appendix a list of end points for the active substance and

Peer review of the pesticide risk assessment of the active substance ethoprophos

www.efsa.europa.eu/efsajournal 1 EFSA Journal 2018;16(5):5290

Appendix to:

EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk

assessment of the active substance ethoprophos. EFSA Journal 2018;16(6):5262, 58 pp.

doi:10.2903/j.efsa.2018.5262

© European Food Safety Authority, 2018

Appendix A – List of end points for the active substance and the representative formulation

Identity, Physical and Chemical Properties, Details of Uses, Further Information (Regulation (EU) N° 283/2013, Annex Part A, points 1.3 and 3.2)

Active substance (ISO Common Name) Ethoprophos

Function (e.g. fungicide) Nematicide and soil insecticide

Rapporteur Member State Italy

Co-rapporteur Member State Ireland

Identity (Regulation (EU) N° 283/2013, Annex Part A, point 1)

Chemical name (IUPAC) O-ethyl S,S-dipropyl phosphorodithioate

Chemical name (CA) Phosphorodithioic acid, O-ethyl S,S-dipropyl ester

CIPAC No 218

CAS No 13194-48-4

EC No (EINECS or ELINCS) 236-152-1

FAO Specification (including year of publication)

There is no FAO specification

Minimum purity of the active substance as

manufactured

950 g/kg

Identity of relevant impurities (of toxicological, ecotoxicological and/or environmental

concern) in the active substance as manufactured

None

Molecular formula C8H19O2PS2

Molar mass 242.3 g/mol

Structural formula



Physical and chemical properties (Regulation (EU) N° 283/2013, Annex Part A, point 2)

Melting point (state purity) <-70.0 °C (99.1%)

Boiling point (state purity) 244.3 °C with decomposition (99.1%)

Temperature of decomposition (state purity) Decomposition starts at 244.3 °C (99.1%)

Appearance (state purity) Clear colourless liquid (99.1%)

Clear colourless liquid (94.4%)

Vapour pressure (state temperature, state

purity)

7.8 × 10-2 Pa (20°C, 99.1%)

12.3 × 10-2 Pa (25C, 99.1%)

Henry’s law constant (state temperature) 1.35 10-2 Pa m3 mol-1 (20°C)

Solubility in water (state temperature, state purity and pH)

1.3 g/L at 20 °C (pH 4) (99.1%)

1.4 g/L at 20 °C (unbuffered) (99.1%)

1.3 g/L at 20 °C (pH 9) (99.1%)

Solubility in organic solvents (state temperature, state purity)

> 500 g/L in: acetone; acetonitrile; dichloromethane; ethyl acetate; n-hexane;

methanol; n-octanol and toluene (at 22-24°C room

temperature, 94.4%)

Surface tension

(state concentration and temperature, state

purity)

45.1 mN/m at 20 °C (90 % saturated solution)

(99.1%)

45.9 mN/m at 20 °C (90 % saturated solution) (94.4%)

Partition coefficient

(state temperature, pH and purity)

log POW = 2.99 at 35°C

within a 95% confidence range of 2.9 to 3.1

(HPLC method, unbuffered mobile phase) (99.1%)

Dissociation constant (state purity) No dissociation occurs.

UV/VIS absorption (max.) incl.

(state purity, pH)

Acid methanol solution (99.1%)

max (nm) (L mol-1 cm-1)

269.0 1724

Neutral methanol solution (99.1%):


231.0 725

Basic methanol solution (99.1%):


268.0 3815

at > 290 nm: no absorbance

Flammability (state purity) Flash point = 141°C - Not flammable (94.4%)

Self-ignition temperature: 280°C (94.4%)

Explosive properties (state purity) Not explosive (94.4%)

Oxidising properties (state purity) Data gap



Summary of representative uses evaluated, for which all risk assessments needed to be completed (Ethoprophos) (Regulation (EU) N° 284/2013, Annex Part A, points 3, 4)

Crop

and/or

situation

(a)

Member

State

or

Country

Product

name

F

G

or

I (b)

Pests or

Group of

pests

controlled

(c)

Preparation Application Application rate per treatment

PHI

(days) (m)

Remarks Type

(d-f)

Conc. a.s.

(i)

method kind

(f-h)

range of

growth stages

& season (j)

number min-max

(k)

Interval

between

application (min)

kg a.s

/hL

min-max (l)

Water L/ha

min-max

kg a.s./ha min-max

(l)

Potato Central and

Southern

zone

MOCAP 15G®1

F Soil nematodes

and insects

GR 150 g/kg

Overall application

followed by

soil incorporation

Pre planting 1 - - 4 - 6 80 Representative use Central and Southern

zone**

Early and late potatoes

Potato Central

and Southern

zone

MOCAP

15G

F Soil

nematodes and insects

GR 150

g/kg

Band / row

application followed by

soil

incorporation*

Pre planting 1 - - 4 - 6 80 Representative use

Central and Southern zone**

Early and late potatoes

* Includes application of MOCAP as an 'in furrow application' at planting ** Please note that in the Southern zone MOCAP 10G is used, however at the same application rate with regard to active substance

(a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure)

(b) Outdoor or field use (F), greenhouse application (G) or indoor application (I)

(c) e.g. biting and sucking insects, soil born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of

pesticide (f) All abbreviations used must be explained

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of equipment

used must be indicated

(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in different variants (e.g.

fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give

the rate for the variant (e.g. benthiavalicarb-isopropyl). (j) Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of

application (k) Indicate the minimum and maximum number of applications possible under practical conditions of use

(l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha

instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha

(m) PHI - minimum pre-harvest interval

1 MOCAP is a registered trademark of AMVAC Chemical Corporation and its affiliates



Summary of additional intended uses for which MRL applications have been made, that in addition to the uses above, have also been considered in the consumer risk assessment (Ethoprophos) Regulation (EC) N° 1107/2009 Article 8.1(g)) Important note: efficacy, environmental risk and risk to humans by exposure other than via their diet have not been assessed for these uses

Crop

and/or

situation

(a)

Member

State

or

Country

Product

name

F

G

or

I (b)

Pests or

Group of

pests

controlled

(c)

Preparation Application Application rate per treatment

PHI

(days) (m)

Remarks Type (d-f)

Conc.

a.s.

(i)

method

kind

(f-h)

range of

growth stages & season

(j)

number

min-max

(k)

Interval

between application

(min)

kg a.s

/hL min-max

(l)

Water

L/ha

min-max

kg a.s./ha

min-max

(l)

MRL Application (according to Article 8.1(g) of Regulation (EC) No 1107/2009)

Not applicable. There are no additional intended uses for which MRL applications have been made.

(a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use

situation should be described (e.g. fumigation of a structure)

(b) Outdoor or field use (F), greenhouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil born insects, foliar fungi, weeds

(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide

(f) All abbreviations used must be explained

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of equipment

used must be indicated

(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for

the variant in order to compare the rate for same active substances used in different variants (e.g.

fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give

the rate for the variant (e.g. benthiavalicarb-isopropyl).

(j) Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application

(k) Indicate the minimum and maximum number of applications possible under practical conditions of use

(l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha

(m) PHI - minimum pre-harvest interval



Further information, Efficacy

Effectiveness (Regulation (EU) N° 284/2013, Annex Part A, point 6.2)

Ethoprophos is an organophosphate soil insecticide and

nematicide with contact action. It is used for control of

soil insects (e.g. wireworms) and plant parasitic

nematodes in potatoes, ornamentals, many vegetables,

tobacco, bananas, sugar cane, turf and other crops.

Ethoprophos irreversibly inhibits acetylcholinesterase, an

essential enzyme in the cholinergic pathway terminating

nerve transmission by hydrolysis of the natural

neurotransmitter acetylcholine.

Adverse effects on field crops (Regulation (EU) N° 284/2013, Annex Part A, point 6.4)

Ethoprophos has been widely used in potato crops for

many years, including those destined for use as seed. It

is used close to harvest, and no adverse effects have

occurred in many years of commercial use. NOTE: Some

potato varieties grown under certain soil conditions such

as sandy soils with low pH, may exhibit delayed

emergence when the tubers are treated with MOCAP 15G

during planting time.

Observations on other undesirable or unintended side-effects (Regulation (EU) N° 284/2013, Annex Part A, point 6.5)

No undesirable or unintended side-effects have been

reported. There is low potential of drift, and the fact that

the granules are incorporated into the soil directly after

application means that there is little opportunity for the

granules to be re-distributed and have an effect on any

adjacent crops.

Groundwater metabolites: Screening for biological activity (SANCO/221/2000-rev.10-

final Step 3 a Stage 1)

Activity against target organism Open



Methods of Analysis

Analytical methods for the active substance (Regulation (EU) N° 283/2013, Annex Part A, point 4.1 and Regulation (EU) N° 284/2013, Annex Part A, point 5.2)

Technical a.s. (analytical technique) GC-FID

Impurities in technical a.s. (analytical technique) GC-FID

Plant protection product (analytical technique) GC-FID

Analytical methods for residues (Regulation (EU) N° 283/2013, Annex Part A, point 4.2 & point 7.4.2)

Residue definitions for monitoring purposes

Food of plant origin Ethoprophos

Food of animal origin Open

Soil Ethoprophos, tentative for other metabolites

Sediment Ethoprophos

Water surface Ethoprophos, tentative for other metabolites

drinking/ground Ethoprophos, tentative for other metabolites

Air Ethoprophos

Body fluids and tissues Ethoprophos and EPPA

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique and

LOQ for methods for monitoring purposes)

Orange (high acid), oil seed rape (high oil), cucumber

(high water) and wheat grain (dry matrix)

LC-MS/MS, LOQ: 0.01 mg/kg

ILV: orange and cucumber – LOQ: 0.01 mg/kg

Data gap: Extraction efficiency

Food/feed of animal origin (analytical technique and

LOQ for methods for monitoring purposes)

Open

Soil (analytical technique and LOQ)

LC-MS/MS, LOQ: 0.01 mg/kg

Water (analytical technique and LOQ)

Surface and drinking water

LC-MS/MS, LOQ: 0.1 µg/L

ILV: drinking water – LOQ: 0.1 µg/L

Air (analytical technique and LOQ)

LC-MS/MS, LOQ: 300 µg/m3

Data gap: additional validation data for the submitted

method or a new method with a LOQ in compliance with

the requirements for the operators, workers, residents

and bystanders risk assessment

Body fluids and tissues (analytical technique and

LOQ)

Porcine muscle and porcine urine

LC-MS/MS, LOQ: 0.01 mg/kg in porcine muscle and 0.01

mg/L in porcine urine

Data gap: method for EPPA



Classification and labelling with regard to physical and chemical data (Regulation (EU) N° 283/2013, Annex Part A, point 10)

Substance Ethoprophos

Harmonised classification according to Regulation

(EC) No 1272/2008 and its Adaptations to Technical

Process [Table 3.1 of Annex VI of Regulation (EC)

No 1272/2008 as amended]2:

None

Peer review proposal 3 for harmonised classification

according to Regulation (EC) No 1272/2008:

None

2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling

and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

3 It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with Regulation (EC) No 1272/2008.



Impact on Human and Animal Health

Absorption, distribution, metabolism and excretion (toxicokinetics) (Regulation (EU) N° 283/2013, Annex Part A, point 5.1)

Rate and extent of oral absorption/systemic

bioavailability

Rapid and extensive absorption (>90%) following oral administration to the rat based on comparison of excretion pattern after oral and intravenous administrations

Evidence of reduced absorption at high dose levels

Toxicokinetics Following a single oral dose, whole blood parameters indicate the kinetics of 14C-ethoprophos was independent of sex

Cmax = 1.5 µg equiv/g (4 mg/kg bw dose level)

Tmax = 0.7 h (4 mg/kg bw dose level)

Thereafter, concentrations of radioactivity declined in a biphasic manner

T½ = 110-124 h (in males and females) (4 mg/kg bw dose level)

AUC (0-∞) = 59-63 µg equiv.h/g (4 mg/kg bw dose level)

AUC (0-∞) = 108 µg equiv.h/g (12.5 mg/kg bw dose level)

AUC (0-∞) = 149 µg equiv.h/g (25 mg/kg bw dose level)

AUC at the higher dose levels was proportionally lower

than at the low dose level, indicating reduced absorption

Distribution Widely distributed. Residues were highest in organs associated with metabolism and excretion (lungs, liver and kidney). Comparison of residues in plasma and whole blood show a proportionally greater association of ethoprophos or a metabolite with the cellular component.

Potential for bioaccumulation No evidence for accumulation

Rate and extent of excretion Excretion was rapid and primarily via the urine (~50-60%). Excretion in the faeces (~10%) and expired air (~15%) were also important routes. Values for intravenously dosed animals indicate that biliary excretion may occur to a limited extent (~8%). Tissue residues at 168 hours were relatively low.

Metabolism in animals Data indicate that metabolism in the rat is independent of sex, route of administration, dose level and frequency of administration. Ethoprophos was completely metabolised; no unchanged parent compound was detected in urine or faecal samples. Metabolism of ethoprophos was by dealkylation of one or both S-propyl groups followed by hydroxylation and conjugation. Ethoprophos may also be metabolised by hydrolysis of the ethyl ester linkage to ethanol and CO2.

In vitro metabolism Biological monitoring study in agricultural operator indicate that the metabolite O-ethyl S-propyl

phosphorothioate (M1M or EPPA) is more predominant in humans than in rats (and is considered as a reasonable biomarker of ethoprophos exposure in humans), however since no further information on human metabolites was retrieved from the studies in humans, an in vitro interspecies comparative metabolism study is needed (data gap)



Toxicologically relevant compounds

(animals and plants)

Ethoprophos

The toxicity of metabolites identified in plants (M5, M31 and M18) is considered covered by toxicity and concerns on the parent (genotoxicity of the parent is not clarified)

Toxicologically relevant compounds

(environment)

Ethoprophos

Acute toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.2)

Rat LD50 oral Rat: 40-80 mg/kg bw

Mouse: 31 mg/kg bw

H301

Rat LD50 dermal Rat: 226 mg/kg bw

Rabbit: 8.5 mg/kg bw

H310

Rat LC50 inhalation 0.123 mg/L air (4 hr, nose only) H330

Skin irritation Not determined due to toxicity (dermal exposure of 0.5 ml killed all 6 rabbits)

Eye irritation No study submitted

US EPA reports that all animals died after ocular instillation of 0.1 ml

EUH070

Skin sensitisation Sensitising (Magnusson-Kligman Maximisation Test)

H317

Phototoxicity No phototoxic potential

Short-term toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.3)

Target organ / critical effect Rat (oral, dermal and inhalation exposure) & mouse (oral administration): erythrocyte and brain cholinesterase inhibition

Dog: Brain and erythrocyte cholinesterase inhibition and liver vacuolisation

Rabbit (dermal exposure): erythrocyte and brain cholinesterase inhibition

Relevant oral NOAEL 90-day, rat: 0.1 mg/kg bw per day

6-week, mouse: LOAEL 20 mg/kg bw per day

90-day & 1-year, dog: 0.025 mg/kg bw per day

Relevant dermal NOAEL 21-day, rabbit: 0.05 mg/kg bw per day

21-day, rat: 0.3 mg/kg bw per day

Relevant inhalation NOAEL 28-day, rat: 0.498 µg/L corresponding to 0.1 mg/kg bw per day

Genotoxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.4)

In vitro studies Bacterial reverse mutation test (No TA102/E. coli WP2: Negative (however strains sensitive to cross-linking and oxidizing mutagens (TA102 or E. coli WP2 strain) have not been



investigated) (data gap)

Mammalian cell gene mutation test: (CHO cells (HGPRT)): Equivocal

Sister chromatid exchange (CHO cells): positive

Clastogenicity test: (Chinese hamster lung (CHL) cells): positive

Unscheduled DNA synthesis (rat hepatocytes): Negative

In vivo studies Somatic cells (limited reliability):

Rat bone marrow clastogenicity: Negative (insufficient exposure)

Rat bone marrow clastogenicity: Equivocal (low number of cells investigated)

Germ cells (limited reliability, deviations from test guidelines):

Rat dominant lethal: Positive (lack of data reporting)

Rat dominant lethal: Negative

Photomutagenicity No phototoxic potential

Potential for genotoxicity Based on incomplete Ames tests, equivocal test for gene mutation in mammalian cells in vitro and positive clastogenic effects in vitro that could not be ruled out with robust in vivo assays, a potential for genotoxicity or clastogenicity of ethoprophos cannot be excluded.

Long-term toxicity and carcinogenicity (Regulation (EU) N°283/2013, Annex Part A, point 5.5)

Long-term effects (target organ/critical effect) Rat: Cholinesterase inhibition, reduced haemoglobin concentration, haematocrit and erythrocyte counts observed above the carcinogenic LOAEL

Mouse: Erythrocytes and brain cholinesterase inhibition

Relevant long-term NOAEL LOAEL: 0.04 mg/kg bw per day (2-year, rat)

0.25 mg/kg bw per day (18-month, mouse)

Carcinogenicity (target organ, tumour type) Rat: increased incidence of malignant pheochromocytoma at the LOAEL

Classification regarding carcinogenicity is proposed, based on different types of tumours (uterus endometrial adenoma and carcinoma, malignant pheochromocytoma and thyroid C cells carcinoma) observed in one species but two different strains and in independent studies

Mouse: No neoplastic responses observed in either sex.

H351

Relevant NOAEL for carcinogenicity Rat: LOAEL 0.04 mg/kg bw per day based on increased incidence in malignant pheochromocytoma



Mouse: 4 mg/kg bw per day (the highest dose tested)

Reproductive toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.6)

Reproduction toxicity

Reproduction target / critical effect Parental toxicity: Reduced body weight/bw gain and food consumption

Reproductive toxicity: Reduced litter size

Offspring’s toxicity: Reduced body weight/bw gain at weaning and postnatal mortality

Relevant parental NOAEL 2.3 mg/kg bw per day

Relevant reproductive NOAEL 5.24 mg/kg bw per day

Relevant offspring NOAEL 2.3 mg/kg bw per day

Developmental toxicity

Developmental target / critical effect Rat:

Maternal toxicity: reduced body weights, mortality, abortion

Developmental toxicity: abortions

Rabbit:

Maternal toxicity: reduced body weight gain

Developmental toxicity: no effects, but inadequate reporting of foetal results and low number of dams investigated (data gap for a reliable rabbit developmental toxicity study)

Relevant maternal NOAEL Rat: 1.6 mg/kg bw per day

Rabbit: LOAEL 0.125 mg/kg bw per day

Relevant developmental NOAEL Rat: 1.6 mg/kg bw per day

Rabbit: 2.0 mg/kg bw per day (highest dose

tested, however the value is of low reliability)

Neurotoxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.7)

Acute neurotoxicity Rat: FOB, clinical signs, mortality, erythrocyte AChE inhibition

LOAEL 5 mg/kg bw per day for erythrocyte AChE inhibition in females

Repeated neurotoxicity Rat: LOAEL 0.31 mg/kg bw per day for brain AChE inhibition

STOT-

RE 2

Additional studies (e.g. delayed neurotoxicity,

developmental neurotoxicity)

28-day delayed neurotoxicity (hen):

NOAEL 0.15 mg/kg bw per day based on brain and spinal cord AChE inhibition. No evidence of delayed neurotoxicity

Developmental neurotoxicity (rat):

Maternal toxicity LOAEL: 0.3 mg/kg bw per day based on erythrocyte AChE inhibition



Developmental neurotoxicity LOAEL 0.3 mg/kg bw per day based on increase in both motor and locomotor activity at PND 17

Data gap for a comparative AChE assay after repeated dose (available to the US EPA - according to the USEPA assessment, there is a

higher sensitivity in pups compared to in adults)

Other toxicological studies (Regulation (EU) N° 283/2013, Annex Part A, point 5.8)

Supplementary studies on the active substance Rat immunotoxicity NOAEL: >2.43 mg/kg bw per day. No immunotoxic effect. Inhibition of erythrocyte and brain

AChE observed at 0.4 mg/kg bw per day and higher dose levels

Endocrine disrupting properties No convincing evidence for potential adverse interaction with the estrogen, androgen or thyroid endocrine pathways. Ethoprophos was considered positive in the steroidogenesis assay since it increased estradiol production but it demonstrated an equivocal effect on testosterone production. There were no estrogen related effects observed in the in vivo mammalian studies.

The apical effects observed in level 4 and 5 studies (thyroid C cell tumours and pheochromocytoma) could be endocrine-mediated through other modalities (regarding calcitonin or catecholamine) that are not investigated through the OECD conceptual framework. (data gap)

Studies performed on metabolites or impurities

EPPA/M31/M1/M1M (O-ethyl-S-propyl-

phosphorothioate)

Rat oral LD50: 246 mg/kg bw (females)

RBC (64%) and brain (70%) AChE inhibition at 200

mg/kg bw

Covered by toxicity (and concerns) established for the

parent ethoprophos

M5 (O-ethyl phosphoric acid) Rat oral LD50: > 2000 mg/kg bw

RBC (30%) and brain (32%) AChE inhibition at 2000

mg/kg bw

Covered by toxicity (and concerns) established for the

parent ethoprophos

SME (O-ethyl-S-methyl-S-phosphorodithioate) Rat oral LD50: 50.0 mg/kg bw

Brain AChE inhibition (71%) > ethoprophos (32%)

OME (O-ethyl-O-methyl-S-phosphorothioate Rat oral LD50: 22.4 mg/kg bw

RBC and Brain AChE inhibition OME > ethoprophos

M18 (conjugate of O-ethylphosphorothioate) Covered by toxicity (and concerns) established for the

parent ethoprophos



Medical data (Regulation (EU) N° 283/2013, Annex Part A, point 5.9)

Cholinesterase inhibition:

Regular worker monitoring for cholinesterase inhibition

has been reported in the previous assessment (2004), an

update of the monitoring performed until now and

submission of the respective occupational report is

needed (data gap)

Skin sensitisation:

Three out of 366 banana plantation workers in Central

America (37 who exhibited dermatoses were patch tested

out of 366 interviewed) were found to have become

sensitised to ethoprophos , demonstrating the weak skin

sensitisation potential of ethoprophos

Poisoning:

In cases of deliberate intake of ethoprophos, symptoms

and signs of poisoning included nausea, vomiting,

diarrhoea, miosis, abdominal cramps, muscular

weakness, bronchial hypersecretion, dyspnoea, anxiety,

confusion and convulsions.

A combination of atropine and pralidoxime (2-PAM)

would be the most effective antidote in cases of

ethoprophos poisoning

Summary4 (Regulation (EU) N°1107/2009, Annex II, point 3.1 and

3.6)

Value

(mg/kg bw (per day))

Study

Uncertainty factor

Acceptable Daily Intake (ADI) Not established due to genotoxic concern (1)

Acute Reference Dose (ARfD) Not established due to genotoxic concern (2)

Acceptable Operator Exposure Level (AOEL) Not established due to genotoxic concern (3)

Acute Acceptable Operator Exposure Level (AAOEL) Not established

due to genotoxic

concern

(1) previously set ADI 0.0004 mg/kg bw per day (European

Commission, 2013) (2) previously set ARfD 0.01 mg/kg bw (European

Commission, 2013) (3) previously set AOEL 0.001 mg/kg bw per day

(European Commission, 2013)

4 If available include also reference values for metabolites



Dermal absorption (Regulation (EU) N° 284/2013, Annex Part A, point 7.3)

Representative formulation (MOCAP 15G, granule

formulation containing 150 g ethoprophos/kg)

2% for the granule formulation

based on in vitro study on human skin

Exposure scenarios (Regulation (EU) N° 284/2013, Annex Part A, point 7.2)

Operators Measurements of operator exposure to ethoprophos have

been carried out in biomonitoring studies with MOCAP

10G or 15G. From these studies, estimates of exposure to

ethoprophos from MOCAP 15G application have been

calculated.

However no risk assessment could be conducted since no

AOEL could be derived for ethoprophos.

Workers MOCAP 15G applications are followed by immediate soil

incorporation.

An air monitoring study was performed by US EPA

(1998).

However no risk assessment could be conducted since no

AOEL could be derived for ethoprophos.

Bystanders and resident No risk assessment could be conducted since no AOEL

could be derived for ethoprophos.

Classification with regard to toxicological data (Regulation (EU) N° 283/2013, Annex Part A, Section 10)

Substance: Ethoprophos





Acute Tox. 3* – H301 ‘toxic if swallowed’

Acute Tox. 1 – H310 ‘fatal in contact with skin’

Acute Tox. 2* – H330 ‘fatal if inhaled’

Skin Sens. 1 – H317 ‘may cause an allergic skin reaction’

Peer review proposal6 for harmonised classification


Same as above, in addition :

EUH070 ‘toxic by eye contact’

Carc. 2 - H351 ‘Suspected of causing cancer’

STOT RE 2 – H373 ‘may cause damage to organs

(nervous system) through prolonged or repeated

exposure’

*minimum classification (see section 1.2.1 of Annex VI of

CLP Regulation)

5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling

and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.




Residues in or on treated products food and feed

Metabolism in plants (Regulation (EU) N° 283/2013, Annex Part A, points 6.2.1, 6.5.1, 6.6.1 and 6.7.1)

Primary crops

(Plant groups covered)

OECD Guideline 501

Crop groups Crop(s) Application(s) DAT (days)

Root crops Potatoes Soil incorporation

Leafy vegetables Cabbages Soil incorporation

Fruit crops Sweet corn Soil incorporation

The proposed metabolic pathway of ethoprophos in plants shows that hydrolysis of the thiopropylesters leads to the main metabolite ethylphosphate (M5).

Rotational crops

(metabolic pattern)

OECD Guideline 502

Crop groups Crop(s) PBI (days) Comments

Root/tuber crops radishes 21-30, 120-152, 291-365

Bare soil application at 11.5-13.4 kg a.s./ha (ca. 2 N rate).

Leafy crops spinaches

Cereals (small grain) wheat, spring

Rotational crop and

primary crop metabolism

similar?

Yes

Processed commodities

(standard hydrolysis

study)

OECD Guideline 507

Conditions

Data gap: A hydrolysis study addressing the nature of residues of all compounds included in the proposed risk assessment residue definition for plants and simulating pasteurisation, baking/boiling and sterilisation is required.

Residue pattern in

processed commodities

similar to residue pattern

in raw commodities?

Open

Primary crops: Plant residue definition for

monitoring (RD-Mo)

OECD Guidance, series on pesticides No 31

Ethoprophos – All crop categories.

Primary crops: Plant residue definition for risk

assessment (RD-RA)

Ethoprophos and M5, expressed as ethoprophos – All

crop categories.

Rotational crops: Plant residue definition for

monitoring (RD-Mo)

ethoprophos

Rotational crops: Plant residue definition for risk

assessment (RD-RA)

ethoprophos, EPPA and M5, expressed as ethoprophos.

Conversion factor (monitoring to risk assessment)

Open



Metabolism in livestock (Regulation (EU) N° 283/2013, Annex Part A, points 6.2.2, 6.2.3, 6.2.4, 6.2.5 6.7.1)

OECD Guideline 503 and

SANCO/11187/2013 rev. 3 (fish)

Animal Dose

(mg/kg bw/d)

Duration

(days)

N rate/comment

Animals covered Laying hens 2 ppm diet 7 open

Goats 32 ppm diet 7 open

Metabolism studies in lactating goats and in laying hens not compliant

with the current guidance recommendations.

Time needed to reach a plateau concentration in

milk and eggs (days)

Milk: after first dosing day

Eggs: Not reported

Animal residue definition for monitoring (RD-Mo)

OECD Guidance, series on pesticides No 31

Open

Animal residue definition for risk assessment (RD-

RA)

Open

Conversion factor (monitoring to risk assessment)

Open

Metabolism in rat and ruminant similar (Yes/No)

Open

Fat soluble residues (Yes/No)

(FAO, 2009)

Open

Residues in succeeding crops (Regulation (EU) N° 283/2013, Annex Part A, point 6.6.2)

Confined rotational crop study

(Quantitative aspect)

OECD Guideline 502

Old study (1992):

Metabolite M5 was shown to be the most pertinent

residue across the tested rotational crops and at the

different plant back intervals (PBIs) (17% to 51% TRR).

Most recent study (2007):

EPPA compound was the major residue across the

different rotational crops at 21 d-PBI (13 to 23% TRR),

except in wheat straw and grain where it was hardly

detected and accounted for up to 25% TRR in immature

spinaches at 152 d-PBI.

Field rotational crop study

OECD Guideline 504

Data gap for the submission of sufficient rotational crops residue trials analysing for ethoprophos, EPPA and M5 residues and covered by acceptable storage stability data.

Stability of residues (Regulation (EU) N° 283/2013, Annex Part A, point 6.1)

OECD Guideline 506

Plant products (Category)

Commodity T

(°C)

Stability (Month/Year)

Ethoprophos EPPA OME SME

High water content Tomatoes -18 19 months - - -



High starch content Potatoes -18 19 months 3 months 18 months 18 months

Animal Animal commodity

T (°C)

Stability (Month/Year)

Open



Summary of residues data from the supervised residue trials (Regulation (EU) N° 283/2013, Annex Part A, point 6.3) Guideline 509, OECD Guidance, series on pesticides No 66 and OECD MRL calculator

Crop Region/ Indoor

(a)

Residue levels (mg/kg) observed in the supervised residue trials relevant to the

supported GAPs (b)

Recommendations/comments (OECD calculations)

MRL proposals (mg/kg)

HR (mg/kg)

(c)

STMR (mg/kg)

(d)

Representative uses

Potatoes Northern Europe

(Central zone), outdoor

RDMo:

Unscaled residue values: 4x<0.001; 0.001(1); 0.003(1); 0.009(1); 0.032(1)

Scaled residue values: 4x<0.001; <0.001; 0.0016; 0.0048; 0.0173

RDRA: -

Residue trials conducted with 1 application

at 11.1 kg a.s./ha; PHI 60/80 days. (1)Proportionality principle is applicable.

0.03

(Provisional)

0.02 0.001

Outdoor, Southern

Europe

RDMo:

Unscaled residue values: 5x<0.001; 2x0.001(1);

0.008(1); 3x<0.01; 0.011(1); 0.019(1)

Scaled residue values: 5x<0.001; 2x<0.001;0.0043; 3x<0.01; <0.01; 0.011

RDRA: -

Residue trials conducted with 1 application

at 11.1 kg a.s./ha; PHI 60/80 days. (1)Proportionality principle is applicable.

0.03

(Provisional)

0.01 0.001

Summary of the data on formulation equivalence OECD Guideline 509

Crop Region Residue data (mg/kg) Recommendations/comments

Summary of data on residues in pollen and bee products (Regulation (EU) No 283/2013, Annex Part A, point 6.10.1)

Data gap: Determination of the residues in pollen and bee products for human consumption resulting from residues taken up by honeybees from crops at blossom is required as uptake and translocation of ethoprophos residues throughout the plants was demonstrated to occur from the available plant metabolism studies. A detailed assessment of the cited literature data to conclude on the non-relevance of ethoprophos residues in pollen and honey is also required.

(a): NEU or SEU for northern or southern outdoor trials in EU member states (N+SEU if both zones), Indoor for glasshouse/protected crops, Country if non-EU location. (b): Residue levels in trials conducted according to GAP reported in ascending order (e.g. 3x <0.01, 0.01, 6x 0.02, 0.04, 0.08, 3x 0.10, 2x 0.15, 0.17). When residue definition for monitoring and risk

assessment differs, use Mo/RA to differentiate data expressed according to the residue definition for Monitoring and Risk Assessment. (c): HR: Highest residue. When residue definition for monitoring and risk assessment differs, HR according to residue definition for monitoring reported in brackets (HRMo). (d): STMR: Supervised Trials Median Residue. When residue definition for monitoring and risk assessment differs, STMR according to definition for monitoring reported in brackets (STMRMo).



Inputs for animal burden calculations

Feed commodity Median dietary burden Maximum dietary burden

(mg/kg) Comment (mg/kg) Comment

Representative uses

In the absence of residue trials analysing all the compounds included in the risk assessment residue definitions in primary and rotational crops, a full assessment of the livestock exposure cannot be concluded on.

Residues from livestock feeding studies (Regulation (EU) N° 283/2013, Annex Part A, points

6.4.1, 6.4.2, 6.4.3 and 6.4.4) OECD Guideline 505 and OECD Guidance, series on pesticides No 73 In the absence of residue trials analysing all the compounds included in the risk assessment residue definitions in primary and rotational crops, a full assessment of the livestock exposure cannot be concluded on.

Conversion Factors (CF) for monitoring to risk assessment

Open

Processing factors (Regulation (EU) N° 283/2013, Annex Part A, points 6.5.2 and 6.5.3)

OECD Guideline 508 and OECD Guidance, series on testing and assessment No 96

Crop (RAC)/Edible part or Crop (RAC)/Processed product

Number of

studies(a)

Processing Factor (PF) Conversion Factor (CFP)

for RA(b) Individual values Median PF

Representative uses

Pending upon the outcome of the requested study addressing the nature of the residues at processing, processing trials in potatoes involving a heating step (cooked potatoes, purée, fried potatoes) and analysing for ethoprophos and all relevant degradation products might be needed.

(a): Studies with residues in the RAC at or close to the LOQ should be disregarded (unless concentration) (b): When the residue definition for risk assessment differs from the residue definition for monitoring

Consumer risk assessment (Regulation (EU) N° 283/2013, Annex Part A, point 6.9) Including all representative uses (representative uses and uses related to an MRL application).

Considering that a genotoxic potential cannot be ruled out for ethoprophos, health-based reference values cannot be established for this substance and a dietary risk assessment for the consumer cannot be conducted. The toxicity of metabolites M5 and EPPA is covered by toxicity and concerns of the parent compound.

ADI Open

TMDI according to EFSA PRIMo

NTMDI, according to (to be specified)

IEDI (% ADI), according to EFSA PRIMo

NEDI (% ADI), according to (to be specified)

Factors included in the calculations

ARfD Open

IESTI (% ARfD), according to EFSA PRIMo

NESTI (% ARfD), according to (to be specified)

Factors included in IESTI and NESTI

Additional contribution to the consumer intakes through drinking water resulting from

groundwater metabolite(s) expected to be present above 0.75 µg/L



Not relevant, there are no relevant groundwater metabolites.

Proposed MRLs (Regulation (EU) No 283/2013, Annex Part A, points 6.7.2 and 6.7.3)

Code(a) Commodity/Group MRL/Import tolerance(b) ( mg/kg) and Comments

Plant commodities

Representative uses

Potatoes 0.03 mg/kg

Provisional

The consumer dietary risk assessments cannot be conducted as health-based reference values for ethoprophos have not been set and with regard to the identified data gaps in the residue section.

Animal commodities

Open as the livestock exposure assessment is not finalised.

(a): Commodity code number, as listed in Annex I of Regulation (EC) No 396/2005 (b): MRLs proposed at the LOQ, should be annotated by an asterisk (*) after the figure.



Environmental fate and behaviour

Route of degradation (aerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.1.1)

Mineralisation after 100 days

56-60 % after 90 d, [1-propyl-14C]-label (n7= 2)

Non-extractable residues after 100 days

11-14 % after 90 d, [1-propyl-14C]-label (n8= 2)

Metabolites requiring further consideration

- name and/or code, % of applied (range and

maximum)

Data gap identified for route and rate of degradation

studies.

Route of degradation (anaerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A,

point 7.1.1.2)

Mineralisation after 100 days

No reliable data available

Non-extractable residues after 100 days

No reliable data available

Metabolites that may require further consideration

for risk assessment - name and/or code, % of

applied (range and maximum)

Route of degradation (photolysis) on soil (Regulation (EU) N° 283/2013, Annex Part A,

point 7.1.1.3)

Metabolites that may require further consideration

for risk assessment - name and/or code, % of

applied (range and maximum)

None

Mineralisation at study end

3 % after 30 d, [1-ethyl-14C]-label (n= 1)

Non-extractable residues at study end

3 % after 30 d, [1-ethyl-14C]-label (n= 1)

7 n corresponds to the number of soils. 8 n corresponds to the number of soils.



Rate of degradation in soil (aerobic) laboratory studies active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.1.1 and Regulation (EU) N° 284/2013, Annex

Part A, point 9.1.1.1)

Parent Dark aerobic conditions

Soil type O.C.

(%)

pHa) t. oC / % MWHC DT50 /DT90

(d)

persistence

DT50 (d)

20 C

pF2/10kPab) c)

modelling

St.

(χ2)

Method of

calculation

Sandy clay loam 3.7

7.0 a) 22°C / 50% 21.8 / 89.9

DFOP 21.1 2.73 SFO

Sandy loam 1.9

5.7 a) 22°C / 50% 20.8 / 75.7

FOMC 20.5 2.1 SFO

Humic Sand

(Loamy sand, USDA)

2.3

5.5 b) 20°C / 40% 17.3 / 57.5

SFO 17.3 10.3 SFO

Sandy loam

(Sandy loam, USDA)

1.3

6.5 b) 20°C / 40% 15.1 / 65.6

DFOP 14.7 9.82 SFO

Sandy silt loam

(Silt loam,USDA)

1.4 6.8 b) 20°C / 40%

7.9 / 26.2

SFO 4.2 12.7 SFO

Geometric mean (if not pH dependent) 13.6

pH dependence No a) Measured in water (sandy clay loam and sandy loam soils) or unknown medium (loamy sand, sandy loam and silt loam soils) b) Measured in unknown medium, non-labelled substance used. c) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7

Rate of degradation field soil dissipation studies (Regulation (EU) N° 283/2013, Annex Part A,

point 7.1.2.2.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.1)

A number of field studies are available, but not completely reliable and usable for modelling purposes. See further

information in the RAR. No further data is required.

Combined laboratory and field kinetic endpoints for modelling (when not from different populations)*

Rate of degradation in soil active substance,

normalised geometric mean (if not pH dependent)

13.6 d (geometric mean of aerobic laboratory studies)

Rate of degradation in soil transformation products,

normalised geometric mean (if not pH dependent)

Not applicable

Kinetic formation fraction (f. f. kf / kdp) of

transformation products, arithmetic mean

Not applicable

* Only relevant after implementation of the published EFSA guidance describing how to amalgamate laboratory and field

endpoints.



Soil accumulation (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.2.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.2)

Soil accumulation and plateau concentration

Not applicable

Rate of degradation in soil (anaerobic) laboratory studies active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.1.3 and Regulation (EU) N° 284/2013,

Annex Part A, point 9.1.1.1)

Parent Dark anaerobic conditions

Soil type O.C. pHa) t. oC / % MWHC DT50 / DT90

(d)

DT50 (d)

20 Cb)

St.

(χ2)

Method of

calculation

No reliable study

available.

a) Measured in [medium to be stated, usually calcium chloride solution or water] b) Normalised using a Q10 of 2.58

Rate of degradation on soil (photolysis) laboratory active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.1.3

Parent Soil photolysis

Soil type Conditions pHa) t. oC / % MWHC DT50 / DT90 (d)

calculated at 40ºN

St.

(χ2)

Method of calculation

Sandy loam Xenon arc,

12-hr

light/dark

Air-dry soil

6.8 25°C Stable - -

a) Measured in unknown medium



Soil adsorption active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.3.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Parent

Soil Type OC % Soil pHa) Kd

(mL/g)

Kdoc

(mL/g)

KF

(mL/g)

KFoc

(mL/g)

1/n

Sandy loam-1 3.7 7.0 - - 2.44 66 0.93

Sandy clay loam 1.9 5.7 - - 1.61 87 0.90

Strong loamy sand** 2.2 7.4 - - 1.07 82 0.93

Loamy sand-1** 3.9 5.8 - - 1.61 71 0.96

Weak clayey loam-1** 5.7 5.9 - - 5.60 169 0.93

Weak clayey loam-2** 6.5 7.2 - - 1.42 38 0.90

Loamy sand-2** 1.0 6.7 - - 0.56 97 0.92

Geometric mean (if not pH dependent)*

1.63

79.9

0.92

Arithmetic mean (if not pH dependent) 2,04

87.1

0,92

pH dependence No a) Measured in water (sandy loam-1 and sandy clay loam soils) or CaCl2 (other soils)

* Only relevant after implementation of the published EFSA guidance.

** DIN (Germany) classification

Mobility in soil column leaching active substance (Regulation (EU) N° 283/2013, Annex

Part A, point 7.1.4.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Column leaching

Elution (mm): 200 mm

Time period (d): 4 d

Leachate: 1.9-2.2 % total residues/radioactivity in

leachate (not characterised)

Mobility in soil column leaching transformation products (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.4.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point

9.1.2.1)

Column leaching

Aged for one half-life

Elution (mm): 200 mm

Time period (d): 4 d

Leachate: 1.0 – 5.5 % total residues/radioactivity in

leachate (not characterized)

Lysimeter / field leaching studies (Regulation (EU) N° 283/2013, Annex Part A, points

7.1.4.2 / 7.1.4.3 and Regulation (EU) N° 284/2013, Annex Part A, points 9.1.2.2 / 9.1.2.3)

Lysimeter/ field leaching studies

Location: UK Ongar Essex

Study type (e.g. lysimeter, field): lysimeter

Soil properties: 2 sandy soil monoliths, 1.08 m depth,

Dates of application: May (first year only)



Crop : Potato

Interception estimated: Not applicable

Number of applications: 1 years, 1 application per year

Duration: 2 years

Application rate: 9.44 kg a.s./ha/year

Average annual rainfall (mm): 941 mm (over 2 years

total precipitation+irrigation was 1882 mm)

Leachate volume (mm): 645 mm

Annual average concentrations ethoprophos in leachate:

0.143 µg/L and 4.02 µg/L (first year)

0.024 µg/L 0.037 µg/L (second year)

Location: The Netherlands, Vredepeel

Study type (e.g. lysimeter, field): confined field leaching

Soil properties: humic sand soil

Dates of application : November

Crop: winter wheat


Number of applications: 1 years, 1 applications per year

Duration: ca. 18 months


Average annual rainfall (mm): 533 mm (800 mm rainfall

over ca. 18 month study duration)

No ethoprophos was found in ground water samples at

any level and any sampling time >LOQ 0.1 µg/L,

shallowest samples of aquifer water taken at 1.0 - 1.2 m.

Location: The Netherlands


Soil properties: gley podzol (sandy) soil, shallow aquifer

Dates of application: November1990

Crop: winter wheat


Number of applications: 1 year, 1 applications per year

Duration: ca. 16 months


Ethoprophos did not leach below 20 cm.

Location: The Netherlands, Ottersum


Soil properties: loamy sand/sand

Dates of application : April 2002

Crop: potato



Duration: 2 years

Application rate: 10 kg a.s./ha/year

Ethoprophos not detected in groundwater above the LOQ

(0.02 µg/L).



Location: Germany, Huelm


Soil properties: silty sand/loamy sand

Dates of application : April 2002

Crop: potato



Duration: 2 years

Application rate: 10 kg a.s./ha/year

Ethoprophos not detected in groundwater above the LOQ

(0.02 µg/L).



Hydrolytic degradation (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.1.1

Hydrolytic degradation of the active substance and

metabolites > 10 %

pH 3 and pH 6 (20°C): Stable

pH 5 and pH 7 (25°C): Stable

pH 9 - 25°C, [1-ethyl-14C]: DT50 = 83 days; ethanol and S,S-dipropyl phosphorodithioic acid formed - 20°C-80C° [1-propyl-14C], sterile: DT50 = 849-1.42 days; S,S-dipropylphosphorodithioic acid formed at T>60°C

Aqueous photochemical degradation (Regulation (EU) N° 283/2013, Annex Part A, points

7.2.1.2 / 7.2.1.3)

Photolytic degradation of active substance and

metabolites above 10 %

Stable in to photolysis (the estimated half-life in exposed

samples is 122 days)

Quantum yield of direct phototransformation in

water at > 290 nm

Estimated to be 0 due to photostability

‘Ready biodegradability’ (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.1)

Readily biodegradable

(yes/no)

No

Aerobic mineralisation in surface water (Regulation (EU) N° 283/2013, Annex Part A,

point 7.2.2.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.2.1)

Parent

System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed

t. oCa)

DT50 /DT90 whole sys.

(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to

20oC

At

study

temp

Normali

sed to

20 oC

Fresh water

(pelagic test)

7.56 –

8.72

NA 20 NA NA NA Essen

tially

stable

- - -

a) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C

Mineralisation and non extractable residues (for parent dosed experiments)

System

identifier

pH

water

phase

pH

sed

Mineralisation

Non-extractable

residues (max)

Non-extractable residues

(end of the study)

Fresh water

(Pelagic test)

7.56 –

8.72

NA 6 - 7% after 59

days (end of the

study)

- -

Water / sediment study (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.3 and

Regulation (EU) N° 284/2013, Annex Part A, point 9.2.2)



Parent Distribution (max in water 88.7 after 0 d. Max. sed 44.5 % after 59 d. (High OC))

Water /

sediment

system

pH

water

phase

pH

sed

t. oC

DT50 /DT90

whole sys.

St.

(χ2)

DT50

/DT90

water

St.

(χ2)

DT50

/DT90

sed

St.

(χ2)

Method of

calculation

Low organic carbon

8.2 - 20

Persistence

69.1/230 2.2 38.5/196 2.8 nc - SFO (sys) HS (water)

Modelling

DT50: 69.1 2.2 DT50: 67.6

2.8 nc - SFO (sys) HS (water)

High organic carbon

7.8 - 20

Persistence

102/338 2.4 21.8/123 2.9 nc - SFO (sys)

DFOP (water)

Modelling

DT50: 102 2.4 DT50: 43.4

2.9 nc - SFO (sys)

DFOP (water)

Geometric mean at 20oC 84.0* - 54.2* - - - -

nc Not calculated * Modelling endpoints

Mineralisation and non extractable residues (from parent dosed experiments)

Water /

sediment

system

pH

water

phase

pH

sed

Mineralisation

(end of the study)

Non-extractable

residues in sed (max)

Non-extractable residues in

sed (end of the study)

Low organic carbon

8.2 - 21.6% AR after 100

days

10.2% AR (maximum) after 100

days

-

High organic carbon

7.8 - 22.0% AR after 100

days

11.6% AR (maximum) after 100

days

-

Fate and behaviour in air (Regulation (EU) N° 283/2013, Annex Part A, point 7.3.1)

Direct photolysis in air Negligible degradation of ethoprophos measured in EPA study at 30°C

Photochemical oxidative degradation in air Standard Atkinson calculation: DT50 = 0.155 days (scenario with 1.5×106 OH radicals per cm3 and a time frame of 12 hours/day) 24h timeframe DT50 = 0.077 days

Volatilisation Not measured. Soil incorporation will reduce the potential to volatilise.

Metabolites Not applicable

Residues requiring further assessment (Regulation (EU) N° 283/2013, Annex Part A, point

7.4.1)

Environmental occurring residues requiring further

assessment by other disciplines (toxicology and

ecotoxicology) and or requiring consideration for

groundwater exposure

Soil: Ethoprophos, open for potential

metabolites (see data gap for soil degradation studies)

Surface water: Ethoprophos, open for potential




Sediment: Ethoprophos, open for potential


Ground water: Ethoprophos, open for potential


Air: Ethoprophos

Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A, point 7.4.2)

Ethoprophos

Monitoring data, if available (Regulation (EU) N° 283/2013, Annex Part A, point 7.5

Soil (indicate location and type of study) No data available

Surface water (indicate location and type of study)

Greece (lakes and rivers) (1996): No ethoprophos was detected above 0.05 µg/L.

Italy (Bracciano lake basin) (1995): Ethoprophos not detected in lake water. Some detections in well water but validity of monitoring questionable.

Ground water (indicate location and type of study)

Netherlands (bulb belt, Fen district and Northern Brabant) (1985 - 1988): Two or three years after the application, ethoprophos residues were not found at concentrations higher than the detection limit (0.02 µg/L).

Netherlands (national monitoring programme) (1985 - 1995): Ethoprophos was only detected at a few locations with concentrations below or at the drinking water limit value, and method may have over-estimated concentrations.

Air (indicate location and type of study)

France (Centre region) (2006 - 2008): Ethoprophos was detected only in two samples in 2008, from one rural site. Overall, the frequency of detection was 1% (n = 262) and the range of measured concentrations was 0.21 - 0.48 ng/m3.

PEC soil (Regulation (EU) N° 284/2013, Annex Part A, points 9.1.3 / 9.3.1)

Parent


(d): 21.7 days * (data gap identified for further

degradation studies in soil)

Kinetics: SFO

Field or Lab: representative worst case from appropriate

field studies.

* a DT50 value of 21.8 days (worst case from the

acceptable laboratory studies) should be selected instead,

but no changes in PECsoil are expected

Application data Crop: potatoes

Depth of soil layer: 15 cm

Soil bulk density: 1.5 g/cm3

% plant interception: Pre-emergence therefore no crop

interception

Number of applications: 1

Interval (d): not applicable

Application rate(s): 6000 g a.s./ha



PEC(s)

(mg/kg)

Single

application

Actual

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial 2.67 - - -

Short term 24h 2.58 2.62 - -

2d 2.50 2.58 - -

4d 2.35 2.50 - -

Long term 7d 21.3 2.39 - -

28d 1.09 1.76 - -

50d 0.54 1.33 - -

100d 0.11 0.80 - -

Plateau

concentration

No accumulation

PEC ground water (Regulation (EU) N° 284/2013, Annex Part A, point 9.2.4.1)

Method of calculation and type of study (e.g.

modelling, field leaching, lysimeter)

Modelling using FOCUS model(s), with appropriate

FOCUSgw scenarios, according to FOCUS guidance

Model(s) used: PEARL (version 4.4.4) and PELMO

(version 5.5.3)

Crop: Potatoes

Crop uptake factor: 0

Water solubility: 1400 mg/L at 30°C

Vapour pressure: 7.8 × 10-2 Pa at 20°C

Geometric mean parent DT50 (normalisation to 10 kPa or

pF2, 20°C with Q10 of 2.58 and Walker equation

coefficient 0.7): 13.6 days (data gap identified for further


KOC / KOM (geometric mean): 101 / 58.6 mL/g*

1/n (arithmetic mean): 0.89*

Application rate Gross application rate: 6000 g/ha

Crop growth stage: Pre-emergence

Canopy interception: 0%

Application rate net of interception: 6000 g/ha

No. of applications: 1

Time of application (absolute or relative application

dates): 14 days pre-emergence

Method of application: Incorporation

Depth of incorporation: 15 cm

Application either every year,

*For future modelling Koc = 79.9 and 1/n = 0.92 must

be used.



PEC(gw) - FOCUS modelling results (80th percentile annual average concentration at 1m)

Results to be considered provisional since new data on degradation in soil are requested and slightly more favourable

adsorption parameters have been used in these simulations. On basis of the results below, the contamination of ground

water in at least one of the relevant scenarios cannot be ruled out.

Po

tato

es

Scenario Parent (µg/L)

Application every year (PEARL) Application every year (PELMO)

Chateaudun 0.002 0.001

Hamburg 0.050 0.041

Jokioinen 0.001 0.002

Kremsmunster 0.032 0.027

Okehampton 0.095 0.071

Piacenza 0.025 0.030

Porto 0.001 0.005

Sevilla 0.000 0.000

Thiva 0.000 0.000

PEC(gw) - From lysimeter / field studies

In a lysimeter study of two years duration (UK, Ongar, Essex) with application of 9.44 kg a.s./ha the first year,

ethoprophos reached levels of 0.143 - 4.02 µg/L the first year, as annual average concentrations in the leachate. In

other lysimeter studies in the Netherlands with application rates of up to 10 kg a.s./ha ethoprophos was not found in the

leachate.

PEC surface water and PEC sediment (Regulation (EU) N° 284/2013, Annex Part A, points 9.2.5

/ 9.3.1)

Parent

Parameters used in FOCUSsw step 1 and 2

Version control no. of FOCUS calculator: “Steps 1-2 in

FOCUS” (version 3.2).

Molecular weight (g/mol): 242.3

KOC: 101 mL/g

DT50 soil: 13.6 days (data gap identified for further


DT50 water/sediment system: 84.0 days

DT50 water: 84.0 days

DT50 sediment: 1000 days

Crop: “No drift (incorporation or seed treatment)”

Crop interception: No interception

Region and season of application: NE, March - May; NE,

June - September; SE, March - May; SE, June -

September

Parameters used in FOCUSsw step 3 (if performed) Version control nos. of FOCUS software: SWASH (version

5.3), MACRO (version 5.5.4), PRZM (version SW 4.3.1)

and TOXSWA (version 4.4.3).

Water solubility: 1400 mg/L at 30°C

Vapour pressure: 7.8 × 10-2 Pa at 20°C

KOC / KOM: 101 / 58.6 mL/g**

1/n: 0.89 (soil, surface water, sediment)**



Q10 = 2.58, Walker equation coefficient = 0.7

Crop uptake factor: 0

Canopy washoff factor: 50 m-1 (lumped)

Application rate Crop and growth stage: Potatoes, pre-emergence

Number of applications: 1

Interval: not applicable

Application rate: 6000 g a.s./ha

Application window: 30 days starting 14 days before

emergence date

Application method: Granular*

Depth of incorporation (R scenarios): 15 cm

CAM (R scenarios): 6 (broadcast application followed by

incorporation); 5 (in-furrow application)

Separate Step 3 assessment including dust drift based on

EFSA guidance

Additional Step 4 assessments in R scenarios carried out

for broadcast application followed by incorporation: 10

and 20 m vegetated buffer strips

*correct value to use according to EFSA Journal (2004)

145, 1-31

**For future modelling Koc = 79.9 and 1/n = 0.92 must

be used.



Results to be considered provisional since new data on degradation in soil are requested and slightly more favourable

adsorption parameters have been used in these simulations.

FOCUS STEP 1

Scenario

Day after

overall

maximum

PECSW (µg/L) PECSED (µg/kg)

Actual TWA Actual TWA

0 h 1760 - 1780 -

FOCUS STEP 2

Scenario

Day after

overall

maximum



Northern EU March-May 0 h 287 - 290 -

Northern EU June-Sept 0 h 287 - 290

Southern EU March-May 0 h 575 - 580

Southern EU June-Sept 0 h 431 - 436

FOCUS STEP 3

Scenario

Water

body

Day after

overall

maximum



In furrow application (followed by incorporation)

D3 Ditch 0 h <1E-6 - 0.000018 -

24 h <1E-6 <1E-6 <1E-6 0.00002

2 d <1E-6 <1E-6 <1E-6 0.00002

4 d <1E-6 <1E-6 - 0.00002

7 d <1E-6 <1E-6 - 0.00002

14 d <1E-6 <1E-6 - 0.00002

21d <1E-6 <1E-6 - 0.00002

28 d <1E-6 <1E-6 - 0.00002

42 d <1E-6 <1E-6 - 0.00002

D4 Pond 0 h 0.4398 - 1.838 -

24 h 0.4395 0.4397 1.838 1.838

2 d 0.4388 0.4396 1.838 1.838

4 d 0.4360 0.4393 1.838 1.838

7 d 0.4304 0.4387 1.838 1.838

14 d 0.4147 0.4362 1.836 1.838

21 d 0.3992 0.4318 1.832 1.838

28 d 0.3924 0.4266 - 1.838

42 d 0.3751 0.4163 - 1.836

D4 Stream 0 h 0.3428 - 0.8533 -

24 h 0.3246 0.3254 0.8520 0.8531

2 d 0.3235 0.3222 0.8493 0.8527

4 d 0.3069 0.3125 0.8442 0.8514

7 d 0.2214 0.2930 0.8401 0.8491



14 d 0.1989 0.2572 0.8130 0.8453

21 d 0.1590 0.2354 0.7919 0.8397

28 d 0.1179 0.2135 0.7774 0.8336

42 d 0.0906 0.1769 0.7914 0.8197

D6 Ditch 1 0 h 35.40 - 12.14 -

24 h 18.21 33.06 10.73 11.91

2 d 6.711 27.24 9.099 11.36

4 d 1.796 17.11 7.249 10.15

7 d 1.012 10.49 6.070 8.830

14 d 0.5163 5.989 4.844 7.222

21 d 0.8372 4.324 4.586 6.406

28 d 0.8132 3.414 4.421 5.941

42 d 0.7482 2.560 4.192 5.402

D6 Ditch 2 0 h 52.17 - 17.93 -

24 h 27.25 46.85 16.35 17.69

2 d 11.03 37.42 14.22 17.07

4 d 3.679 23.66 14.56 16.04

7 d 8.737 19.15 15.44 15.85

14 d 3.770 13.51 14.87 15.50

21 d 2.766 10.70 13.57 15.25

28 d 2.828 8.731 12.79 14.74

42 d 2.103 6.621 11.75 13.92

R1 Pond 0 h 0.0147 - 0.0332 -

24 h 0.0145 0.015 0.0332 0.033

2 d 0.0142 0.014 0.0332 0.033

4 d 0.0138 0.014 0.0332 0.033

7 d 0.0136 0.014 0.0331 0.033

14 d 0.0127 0.014 0.0329 0.033

21 d 0.0115 0.013 0.0325 0.033

28 d 0.0105 0.013 0.0321 0.033

42 d 0.0086 0.012 0.0310 0.033

R1 Stream 0 h 1.180 - 0.2272 -

24 h 0.0006 0.510 0.0931 0.159

2 d 0.0002 0.255 0.0687 0.123

4 d 0.0001 0.128 0.0502 0.092

7 d 0.0576 0.073 0.0644 0.072

14 d 0.0002 0.048 0.0549 0.060

21 d 0.0000 0.033 0.0367 0.054

28 d 0.0000 0.025 0.0307 0.049



42 d 0.0000 0.017 0.0242 0.042

R2 Stream 0 h 1.089 - 0.3205 -

24 h 0.0410 0.6575 0.1932 0.268

2 d 0.0005 0.4975 0.2029 0.253

4 d 0.0002 0.2740 0.1414 0.219

7 d 0.0002 0.1807 0.1409 0.193

14 d 0.0000 0.0908 0.1053 0.158

21 d 0.0000 0.0611 0.0839 0.137

28 d 0.0000 0.0477 0.0788 0.124

42 d 0.0000 0.0318 0.0636 0.107

R3 Stream 0 h 5.157 - 0.7957 -

24 h 0.0386 2.240 0.3844 0.640

2 d 0.0037 1.127 0.2839 0.505

4 d 0.0011 0.5645 0.2084 0.381

7 d 0.0104 0.3864 0.2456 0.316

14 d 0.0002 0.1937 0.1493 0.252

21 d 0.0008 0.1551 0.1829 0.228

28 d 0.0001 0.1164 0.1385 0.211

42 d 0.0001 0.0776 0.1079 0.181

Broadcast application followed by incorporation

D3 Ditch 0 h <1E-6 <1E-6 0.000018 0.00002

24 h <1E-6 <1E-6 <1E-6 0.00002

2 d <1E-6 <1E-6 <1E-6 0.00002

4 d <1E-6 <1E-6 - 0.00002

7 d <1E-6 <1E-6 - 0.00002

14 d <1E-6 <1E-6 - 0.00002

21d <1E-6 <1E-6 - 0.00002

28 d <1E-6 <1E-6 - 0.00002

42 d <1E-6 <1E-6 - 0.00002

D4 Pond 0 h 0.4398 - 1.838 -

24 h 0.4395 0.4397 1.838 1.838

2 d 0.4388 0.4396 1.838 1.838

4 d 0.4360 0.4393 1.838 1.838

7 d 0.4304 0.4387 1.838 1.838

14 d 0.4147 0.4362 1.836 1.838

21 d 0.3992 0.4318 1.832 1.838

28 d 0.3924 0.4266 - 1.838

42 d 0.3751 0.4163 - 1.836

D4 Stream 0 h 0.3428 - 0.8533 -



24 h 0.3246 0.3254 0.8520 0.8531

2 d 0.3235 0.3222 0.8493 0.8527

4 d 0.3069 0.3125 0.8442 0.8514

7 d 0.2214 0.2930 0.8401 0.8491

14 d 0.1989 0.2572 0.8130 0.8453

21 d 0.1590 0.2354 0.7919 0.8397

28 d 0.1179 0.2135 0.7774 0.8336

42 d 0.0906 0.1769 0.7914 0.8197

D6 Ditch 1 0 h 35.40 - 12.14 -

24 h 18.21 33.06 10.73 11.91

2 d 6.711 27.24 9.099 11.36

4 d 1.796 17.11 7.249 10.15

7 d 1.012 10.49 6.070 8.830

14 d 0.5163 5.989 4.844 7.222

21 d 0.8372 4.324 4.586 6.406

28 d 0.8132 3.414 4.421 5.941

42 d 0.7482 2.560 4.192 5.402

D6 Ditch 2 0 h 52.17 - 17.93 -

24 h 27.25 46.85 16.35 17.69

2 d 11.03 37.42 14.22 17.07

4 d 3.679 23.66 14.56 16.04

7 d 8.737 19.15 15.44 15.85

14 d 3.770 13.51 14.87 15.50

21 d 2.766 10.70 13.57 15.25

28 d 2.828 8.731 12.79 14.74

42 d 2.103 6.621 11.75 13.92

R1 Pond 0 h 0.3012 - 0.5745 -

24 h 0.2958 0.298 0.5745 0.574

2 d 0.2913 0.296 0.5744 0.574

4 d 0.2835 0.292 0.5741 0.574

7 d 0.2765 0.287 0.5731 0.574

14 d 0.2539 0.276 0.5692 0.574

21 d 0.2304 0.265 0.5628 0.573

28 d 0.2095 0.254 0.5548 0.572

42 d 0.1718 0.233 0.5357 0.580

R1 Stream 0 h 27.56 - 4.667 -

24 h 0.0106 11.90 1.819 3.189

2 d 0.0038 5.957 1.348 2.455

4 d 0.0013 2.980 0.9894 1.830



7 d 1.259 1.703 1.253 1.429

14 d 0.0024 1.086 0.9867 1.164

21 d 0.0003 0.732 0.6715 1.042

28 d 0.0002 0.551 0.5640 0.937

42 d 0.0001 0.367 0.4501 0.792

R2 Stream 0 h 28.15 - 9.760 -

24 h 1.034 17.00 6.657 8.500

2 d 0.0126 12.74 6.682 8.081

4 d 0.0061 6.990 5.136 7.194

7 d 0.0055 4.555 4.807 6.441

14 d 0.0012 2.288 3.678 5.370

21 d 0.0007 1.536 3.037 4.715

28 d 0.0006 1.180 2.748 4.283

42 d 0.0003 0.786 2.278 3.699

R3 Stream 0 h 136.2 - 18.54 -

24 h 0.9434 59.19 8.988 14.83

2 d 0.0824 29.76 6.668 11.69

4 d 0.0245 14.90 4.949 8.852

7 d 0.2416 10.11 5.655 7.366

14 d 0.0055 5.068 3.491 5.857

21 d 0.0154 3.967 4.024 5.249

28 d 0.0032 2.977 3.111 4.818

42 d 0.0020 1.986 2.444 4.128

FOCUS Step 4

Scenario

(10 m

vegetated

buffer zone)

Water

body

Day after

overall

maximum



In furrow application (followed by incorporation)

D4 Pond 0 h 0.4398 - 1.838 -

24 h 0.4395 0.4397 1.838 1.838

2 d 0.4388 0.4396 1.838 1.838

4 d 0.4360 0.4393 1.838 1.838

7 d 0.4304 0.4387 1.838 1.838

14 d 0.4147 0.4362 1.836 1.838

21 d 0.3992 0.4318 1.832 1.838

28 d 0.3924 0.4266 - 1.838

42 d 0.3751 0.4163 - 1.836

D4 Stream 0 h 0.3428 - 0.8533 -



24 h 0.3246 0.3254 0.8520 0.8531

2 d 0.3235 0.3222 0.8493 0.8527

4 d 0.3069 0.3125 0.8442 0.8514

7 d 0.2214 0.2930 0.8401 0.8491

14 d 0.1989 0.2572 0.8130 0.8453

21 d 0.1590 0.2354 0.7919 0.8397

28 d 0.1179 0.2135 0.7774 0.8336

42 d 0.0906 0.1769 0.7914 0.8197

D6 Ditch 1 0 h 35.40 - 12.14 -

24 h 18.21 33.06 10.73 11.91

2 d 6.711 27.24 9.099 11.36

4 d 1.796 17.11 7.249 10.15

7 d 1.012 10.49 6.070 8.830

14 d 0.5163 5.989 4.844 7.222

21 d 0.8372 4.324 4.586 6.406

28 d 0.8132 3.414 4.421 5.941

42 d 0.7482 2.560 4.192 5.402

D6 Ditch 2 0 h 52.17 - 17.93 -

24 h 27.25 46.85 16.35 17.69

2 d 11.03 37.42 14.22 17.07

4 d 3.679 23.66 14.56 16.04

7 d 8.737 19.15 15.44 15.85

14 d 3.770 13.51 14.87 15.50

21 d 2.766 10.70 13.57 15.25

28 d 2.828 8.731 12.79 14.74

42 d 2.103 6.621 11.75 13.92

R1 Stream 0 h 0.5014 - 0.0992 -

24 h 0.0002 0.2148 0.0413 0.0699

2 d 0.0001 0.1075 0.0304 0.0543

4 d 0.0000 0.0538 0.0222 0.0407

7 d 0.0237 0.0307 0.0280 0.0318

14 d 0.0001 0.0206 0.0249 0.0263

21 d 0.0000 0.0140 0.0164 0.0241

28 d 0.0000 0.0106 0.0137 0.0219

42 d 0.0000 0.0071 0.0108 0.0186

R2 Stream 0 h 0.4961 - 0.1361 -

24 h 0.0195 0.3002 0.0777 0.1133

2 d 0.0002 0.2271 0.0821 0.1063

4 d 0.0001 0.1246 0.0545 0.0901



7 d 0.0000 0.0821 0.0552 0.0783

14 d 0.0000 0.0412 0.0401 0.0630

21 d 0.0000 0.0277 0.0315 0.0540

28 d 0.0000 0.0216 0.0299 0.0487

42 d 0.0000 0.0144 0.0238 0.0415

R3 Stream 0 h 2.352 - 0.3785 -

24 h 0.0181 1.029 0.1839 0.3042

2 d 0.0018 0.5177 0.1354 0.2403

4 d 0.0005 0.2593 0.0991 0.1812

7 d 0.0044 0.1740 0.1125 0.1495

14 d 0.0001 0.0872 0.0692 0.1180

21 d 0.0004 0.0701 0.0860 0.1068

28 d 0.0001 0.0526 0.0649 0.0987

42 d 0.0000 0.0351 0.0505 0.0848

Broadcast application followed by incorporation

D4 Pond 0 h 0.4398 - 1.838 -

24 h 0.4395 0.4397 1.838 1.838

2 d 0.4388 0.4396 1.838 1.838

4 d 0.4360 0.4393 1.838 1.838

7 d 0.4304 0.4387 1.838 1.838

14 d 0.4147 0.4362 1.836 1.838

21 d 0.3992 0.4318 1.832 1.838

28 d 0.3924 0.4266 - 1.838

42 d 0.3751 0.4163 - 1.836

D4 Stream 0 h 0.3428 - 0.8533 -

24 h 0.3246 0.3254 0.8520 0.8531

2 d 0.3235 0.3222 0.8493 0.8527

4 d 0.3069 0.3125 0.8442 0.8514

7 d 0.2214 0.2930 0.8401 0.8491

14 d 0.1989 0.2572 0.8130 0.8453

21 d 0.1590 0.2354 0.7919 0.8397

28 d 0.1179 0.2135 0.7774 0.8336

42 d 0.0906 0.1769 0.7914 0.8197

D6 Ditch 1 0 h 35.40 - 12.14 -

24 h 18.21 33.06 10.73 11.91

2 d 6.711 27.24 9.099 11.36

4 d 1.796 17.11 7.249 10.15

7 d 1.012 10.49 6.070 8.830

14 d 0.5163 5.989 4.844 7.222



21 d 0.8372 4.324 4.586 6.406

28 d 0.8132 3.414 4.421 5.941

42 d 0.7482 2.560 4.192 5.402

D6 Ditch 2 0 h 52.17 - 17.93 -

24 h 27.25 46.85 16.35 17.69

2 d 11.03 37.42 14.22 17.07

4 d 3.679 23.66 14.56 16.04

7 d 8.737 19.15 15.44 15.85

14 d 3.770 13.51 14.87 15.50

21 d 2.766 10.70 13.57 15.25

28 d 2.828 8.731 12.79 14.74

42 d 2.103 6.621 11.75 13.92

R1 Stream 0 h 11.72 - 2.046 -

24 h 0.0047 5.018 0.8049 1.402

2 d 0.0017 2.511 0.5956 1.081

4 d 0.0006 1.256 0.4364 0.8064

7 d 0.5181 0.7181 0.5447 0.6298

14 d 0.0011 0.4611 0.4452 0.5132

21 d 0.0001 0.3109 0.2998 0.4610

28 d 0.0001 0.2341 0.2514 0.4151

42 d 0.0000 0.1561 0.2003 0.3514

R2 Stream 0 h 12.82 - 3.395 -

24 h 0.4913 7.757 2.042 2.871

2 d 0.0051 5.814 2.109 2.698

4 d 0.0023 3.179 1.491 2.320

7 d 0.0022 2.069 1.448 2.032

14 d 0.0004 1.039 1.072 1.652

21 d 0.0002 0.6968 0.8638 1.428

28 d 0.0002 0.5350 0.7883 1.286

42 d 0.0001 0.3567 0.6450 1.098

R3 Stream 0 h 62.12 - 8.690 -

24 h 0.4433 27.19 4.171 6.924

2 d 0.0389 13.68 3.065 5.439

4 d 0.0114 6.849 2.251 4.095

7 d 0.1032 4.558 2.509 3.373

14 d 0.0024 2.284 1.554 2.653

21 d 0.0073 1.793 1.832 2.377

28 d 0.0015 1.346 1.405 2.182

42 d 0.0009 0.8975 1.100 1.867



FOCUS Step 4

Scenario

(20 m

vegetated

buffer zone)

Water

body

Day after

overall

maximum



In furrow application (followed by incorporation) – R scenarios only*

R1 Stream 0 h 0.2561 - 0.0518 -

24 h 0.0001 0.1093 0.0219 0.0368

2 d 0.0000 0.0547 0.0161 0.0286

4 d 0.0000 0.0274 0.0117 0.0215

7 d 0.0120 0.0157 0.0146 0.0168

14 d 0.0000 0.0105 0.0133 0.0139

21 d 0.0000 0.0072 0.0087 0.0127

28 d 0.0000 0.0054 0.0073 0.0116

42 d 0.0000 0.0036 0.0057 0.0099

R2 Stream 0 h 0.2600 - 0.0720 -

24 h 0.0104 0.1574 0.0409 0.0600

2 d 0.0001 0.1191 0.0431 0.0563

4 d 0.0000 0.0653 0.0283 0.0475

7 d 0.0000 0.0430 0.0288 0.0411

14 d 0.0000 0.0216 0.0208 0.0330

21 d 0.0000 0.0145 0.0163 0.0282

28 d 0.0000 0.0113 0.0155 0.0254

42 d 0.0000 0.0075 0.0123 0.0216

R3 Stream 0 h 1.233 - 0.2046 -

24 h 0.0097 0.5403 0.1003 0.1647

2 d 0.0010 0.2720 0.0737 0.1304

4 d 0.0003 0.1363 0.0539 0.0984

7 d 0.0023 0.0908 0.0604 0.0810

14 d 0.0001 0.0455 0.0373 0.0638

21 d 0.0002 0.0366 0.0466 0.0577

28 d 0.0000 0.0275 0.0351 0.0533

42 d 0.0000 0.0183 0.0273 0.0458

Broadcast application followed by incorporation – R scenarios only*

R1 Stream 0 h 5.982 - 1.072 -

24 h 0.0025 2.554 0.4257 0.7375

2 d 0.0009 1.278 0.3147 0.5692

4 d 0.0003 0.6396 0.2304 0.4252

7 d 0.2612 0.3656 0.2856 0.3320



14 d 0.0006 0.2354 0.2372 0.2707

21 d 0.0001 0.1588 0.1590 0.2436

28 d 0.0001 0.1196 0.1333 0.2194

42 d 0.0000 0.0797 0.1061 0.1859

R2 Stream 0 h 6.720 - 1.717 -

24 h 0.2611 4.069 1.000 1.443

2 d 0.0027 3.050 1.039 1.353

4 d 0.0012 1.665 0.7158 1.152

7 d 0.0012 1.083 0.7024 1.001

14 d 0.0002 0.5437 0.5144 0.8079

21 d 0.0001 0.3647 0.4115 0.6946

28 d 0.0001 0.2800 0.3766 0.6241

42 d 0.0000 0.1867 0.3066 0.5307

R3 Stream 0 h 32.57 - 4.688 -

24 h 0.2368 14.28 2.258 3.737

2 d 0.0211 7.182 1.655 2.937

4 d 0.0063 3.597 1.212 2.210

7 d 0.0534 2.380 1.338 1.816

14 d 0.0013 1.193 0.8310 1.424

21 d 0.0040 0.9373 0.9857 1.276

28 d 0.0008 0.7034 0.7542 1.171

42 d 0.0005 0.4692 0.5900 1.002

* see Vol3 CP-B.8.5 for further details on why only R scenarios have been simulated with 20m vegetated buffer zones

Estimation of concentrations from other routes of exposure (Regulation (EU) N° 284/2013,

Annex Part A, point 9.4)


There will be no other routes of exposure

PEC

Maximum concentration

Not applicable



Ecotoxicology

Effects on birds and other terrestrial vertebrates (Regulation (EU) N° 283/2013, Annex Part A, point 8.1 and Regulation (EU) N° 284/2013, Annex Part A, point 10.1)

Species Test substance Time scale End point

Toxicity

(mg/kg bw

per day)

Birds

Bobwhite quail a.s. Acute LD50 6.04

Bobwhite quail a.s. Short-term LD50 6.51

Bobwhite quail a.s. Long-term NOAEL < 0.6*

Mallard duck a.s. Long-term NOAEL < 3.961*

Mallard duck a.s. Long-term NOAEL 1.428**

Mammals

Rat a.s. Acute LD50 40-80

Mouse a.s. Acute LD50 31

Rat Mocap 10G Acute LD50 32.9

Geomean LD50 38.8

Rat a.s. Long-term NOAEL 2.42**

Endocrine disrupting properties (Annex Part A, points 8.1.5)

Pending on the data gap in section 2, further information might be needed to address the endocrine disrupting

properties in wildlife, particularly relevant for the amphibians.

*endpoint considered not suitable to conduct a risk assessment.

**merged data from two multiple generations studies.

Additional higher tier studies (Annex Part A, points 10.1.1.2).

Field studies were submitted in the framework of the renewal of the approval of ethoprophos. For further

information, see revised RAR Vol 3 CP9.

Terrestrial vertebrate wildlife (birds, mammals, reptile and amphibians) (Annex Part A, points 8.1.4, 10.1.3):

No other data available.

Endocrine disrupting properties (Annex Part A, points 8.1.5).

Pending on the data gap in section 2, further information might be needed to address the endocrine disrupting

properties in non-target organisms, particularly relevant for the amphibians.

Toxicity/exposure ratios for terrestrial vertebrates (Regulation (EU) N° 284/2013, Part A,

Annex point 10.1)

Potato (Pre-planting, soil incorporation of granules): 6 kg ethoprophos/ha

Growth stage

Indicator or focal species Time scale DDD

(mg/kg bw

per day)

TER Trigger

Tier 1 (Birds)

Bare soil

Birds ingesting granules as a source of food Not relevant^^

Birds ingesting granules with/as grit Acute 0.169 35.7 10

Birds ingesting granules when seeking seeds as food

Acute 0.19 31.3 10

Birds ingesting granules when eating soil-contaminated food

Acute 1.698 3.55 10

Birds consuming seedlings with Pigeon Acute 1.16 5.2 10



residues from granular applications

Skylark 3.04 1.98

Birds consuming earthworms with residues from granular

applications

Starling*

Acute

2.81 2.15 10

Black Headed Gull*

1.44 4.21 10

Thrush* 2.34 2.58 10

Tier 2 (Birds)

Bare soil Birds ingesting granules

when eating soil-contaminated food Acute 0.1146 52.7 10

Tier 1 (Mammals)

Bare soil

Mammals ingesting granules as a source of food Not relevant

Mammals ingesting granules when eating soil-contaminated food

Acute 0.582 66.7 10

Long-term 0.025 96.8 5

Mammals consuming seedlings with residues from granular

applications

Rabbit Acute

0.61 64 10

Wood mouse 2.05 19

Rabbit Long-term

0.081 29.9 5

Wood mouse 0.273 8.9

Mammals consuming earthworms with residues from granular

applications

Wood mouse

Acute

2.76 14

10 Common shrew

3.42 11

Wood mouse

Long-term

0.08 30.2

5 Common shrew

0.1 24.2

Risk from bioaccumulation and food chain behaviour **

Indicator or focal species Time scale DDD

(mg/kg bw per day) TER Trigger

Fish-eating mammals Long-term 0.319 7.6 5

Earthworms-eating mammals Risk assessment covered by the conventional scheme for granular applications

Risk from consumption of contaminated water

Scenario Indicator or focal species

Time scale DDD

(mg/kg bw per day) TER Trigger

Paddy water Birds acute 0.42 14.3 10

Paddy water Mammals acute 0.22 175 10

Paddy water Mammals Long-term 0.22 11 5

^^ low nutritional value of granules * Focal species considered representative for the central zone. A data gap for the identification of focal species in the

southern zone is set. **Risk from bioaccumulation for earthworm is considered covered by the “Mammals consuming earthworms with

residues from granular applications” scenario

Toxicity data for all aquatic tested species (Regulation (EU) N° 283/2013, Annex Part A, points 8.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.2)*

* This section does not yet reflect the new EFSA Guidance Document on aquatic organisms which has been noted in the meeting of the

Standing Committee on Plants, Animals, Food and Feed on 11 July 2014. 1 (nom) nominal concentration; (im) initial measured concentration; (mm) mean measured concentration; prep.: preparation; a.s.: active

substance

Group Test substance

Time-scale (Test type)

End point Toxicity1

Laboratory tests

Fish

Oncorhynchus mykiss a.s. Acute 96 hr (semi-static)

Mortality, LC50 1.71 mg a.s./L (mm)

Lepomis macrochirus a.s. Acute 96 hr (flow-through)


Cyprinodon variegatus a.s. Acute 96 hr (flow-through)


Oncorhynchus mykiss a.s. Chronic 21 d (flow-through) prolonged toxicity test

Sublethal, NOEC 0.064 mg a.s./L (nom)

Pimephales promelas a.s. Chronic 33 d (flow-through) ELS

Growth, NOEC EC10 EC20

0.026 mg a.s./L (mm) 0.041 mg a.s./L (mm) 0.056 mg a.s./L (mm)



Group Test

substance

Time-scale

(Test type)

End point Toxicity1

Aquatic invertebrates

Daphnia magna a.s. Acute 48 h (static) Immobility, EC50 0.20 mg a.s./L (mm)

Mysidopsis bahia a.s. Acute 96 h (flow-through)


Daphnia magna a.s. Chronic 21 d (semi-static)

Reproduction, NOEC 0.0023 mg a.s./L (mm)

Daphnia magna a.s. Chronic 21 d (semi-static)

Reproduction, NOEC 0.0057 mg a.s./L (mm)

Mysidopsis bahia a.s. Chronic 28 d (flow-through)

Growth, NOEC 0.0014 mg a.s./L (mm)

Chironomus riparius a.s. Chronic 28 d (static) Emergence, NOEC Emergence, EC10

Emergence, EC20

0.002 mg a.s./L (nom) 0.00339 mg a.s./L (nom) 0.00456 mg a.s./L (nom)

Algae

Scenedesmus subspicatus a.s. Chronic 72 h (static) 72h EbC50

72h ErC50

72h EyC50

72h EbC10

72h ErC10

72h EyC10

72h EbC20

72h ErC20

72h EyC20

2.4 mg a.s./L (mm) >3 mg a.s./L (mm) 2.4 mg a.s./L (mm) 0.48 mg a.s./L (mm) 1.4 mg a.s./L (mm) 0.49 mg a.s./L (mm) 0.95 mg a.s./L (mm) 2.8 mg a.s./L (mm) 0.98 mg a.s./L (mm)

Higher plant

No studies submitted

Other organisms

Xenopus laevis a.s. Chronic 21 d (flow-through) AMA

Development, NOEC 0.095 mg a.s./L (mm)

Further testing on aquatic organisms Mesocosm study on fate and effects of ethoprophos in outdoor mesocosm ponds (KCA 8.2.8/01, Bruns et al. 2008). Twelve test tanks (6 m3 water, 1 m water depth) containing natural sediment (14 cm height) and natural communities (inoculated several times) were used in the test; five concentrations were tested (1, 1.78, 3.16, 5.62 µg a.s./L in two ponds, 10 µg a.s./L in one pond, three ponds for control). Taxonomic composition of zooplankton, phytoplankton, macroinvertebrates and emergence of insects were investigated 2 weeks before application and 14 weeks after application. Daphnia longispina and Chydorus sphaericus (both cladocerans) resulted the most sensible species (effect class 1 at 3.16 µg/L and effect class 5 at 5.62 µg/L for D. longispina; effect class 2 at 1.78 µg/L, effect class 3 at 3.16 µg/L and effect class 3 at 5.62 µg/L for C. sphaericus). The proposed endpoint is: 14-week NOEC=0.00178 mg/L

Potential endocrine disrupting properties (Annex Part A, point 8.2.3) A fish short-term reproduction assay was available; due to the high variability in the results in this study, specifically for

what concerns the VTG (vitellogenin) levels and cumulative eggs production, a firm conclusion could not be reached on the basis of it. An amphibian metamorphosis assay (AMA) test was available and possible effects due to thyroid modality cannot be excluded on the basis of this study. Pending on the data gap in section 2, further information might be needed to address the endocrine disrupting properties in non-target organisms, particularly relevant for the amphibians.

Bioconcentration in fish (Annex Part A, point 8.2.2.3)

Active substance Metabolites

logPO/W 2.99 Not applicable

Steady-state bioconcentration factor (BCF)

(total wet weight/normalised to 5% lipid content)

210*

Uptake/depuration kinetics BCF (total wet weight/normalised to 5% lipid content)

Uptake rate constant K1: 18 ppm in water/ppm in fish/day Depuration rate constant K2: 0.085 days-1 T(1/2) for clearance: 8.1 days Time to reach 90% steady-state: 27 days

Annex VI Trigger for the bioconcentration factor

Log10 Pow <3 and <90% hydrolysis over 24 hours

Clearance time (days) (CT50) 50% depuration 8 -12 day



(CT90)

Level and nature of residues (%) in organisms after the 14 day depuration phase

63% (no major metabolites were identified)

Higher tier study No higher tier studies submitted

* based on total 14C



PEC/RAC ratios for the most sensitive aquatic organisms (Regulation (EU) N° 284/2013, Annex Part A, point 10.2)

Maximum PECsw values and RAC values for ethoprophos– application to potato (pre-planting, in-furrow application): 6 kg ethoprophos/ha

Scenario PECSW (µg/L)

Fish acute Tier1

Fish acute Tier2

Fish prolonged

Invertebrate acute Tier1


Invertebrate prolonged

Tier1 Algae Mesocosm

L.

macrochirus Geomean P. promelas M. bahia Geomean M. bahia

S. subspicatus

Aquatic invertebrates, algae, macrophyte

RACsw,ac RACsw,ac RACsw,ch RACsw,ac RACsw,ac RACsw,ch RACsw,ch ETO-RAC

3.2 µg/L 8.04 µg/L 2.6 µg/L 0.19 µg/L 0.62 µg/L 0.14 µg/L 300 µg/L 0.59 µg/L

FOCUS Step 1 1760 550.00 218.91 676.92 9263.16 2838.71 12571.43 5.87 2983.05

FOCUS Step 2 575 179.69 71.52 221.15 3026.32 927.42 4107.14 1.92 974.58

FOCUS Step 3

D3 Ditch <1E-6 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

D4 Pond 0.4398 0.14 0.05 0.17 2.31 0.71 3.14 0.001 0.75

D4 Stream 0.3428 0.11 0.04 0.13 1.80 0.55 2.45 0.001 0.58

D6 Ditch 1 35.40 11.06 4.40 13.62 186.32 57.10 252.86 0.12 60

D6 Ditch 2 52.17 16.30 6.49 20.07 274.58 84.15 372.64 0.17 88.42

R1 Pond 0.0147 0.00 0.00 0.01 0.08 0.02 0.11 <0.0001 0.02

R1 Stream 1.180 0.37 0.15 0.45 6.21 1.90 8.43 0.004 2

R2 Stream 1.089 0.34 0.14 0.42 5.73 1.76 7.78 0.004 1.85

R3 Stream 5.517 1.72 0.69 2.12 29.04 8.90 39.41 0.02 9.35

FOCUS Step 4 (10m VBS)

D4 Pond 0.4398 0.14 0.05 0.17 2.31 0.71 3.14 <0.0001 0.75

D4 Stream 0.3428 0.11 0.04 0.13 1.80 0.55 2.45 <0.0001 0.58

D6 Ditch 1 35.40 11.06 4.40 13.62 186.32 57.10 252.86 0.12 60

D6 Ditch 2 52.17 16.30 6.49 20.07 274.58 84.15 372.64 0.17 88.42

R1 Stream 0.5014 0.16 0.06 0.19 2.64 0.81 3.58 <0.0001 0.85

R2 Stream 0.4961 0.16 0.06 0.19 2.61 0.80 3.54 <0.0001 0.84

R3 Stream 2.352 0.74 0.29 0.90 12.38 3.79 16.80 0.01 3.99

FOCUS Step 4 (20m VBS)*

R1 Stream 0.2561 0.08 0.03 0.10 1.35 0.41 1.83 <0.0001 0.43

R2 Stream 0.260 0.08 0.03 0.10 1.37 0.42 1.86 <0.0001 0.44

R3 Stream 1.233 0.39 0.15 0.47 6.49 1.99 8.81 <0.0001 2.09

Values in bold do not meet the trigger *Only R scenarios were refined with 20m VBS since entry route in D scenarios is drainage and no mitigation measures are available to reduce the contribution.

Maximum PECsw values and RAC values for ethoprophos– application to potato (pre-planting, broadcast application): 6 kg ethoprophos/ha

Scenario PECSW (µg/L)

Fish acute Tier1

Fish acute Tier2

Fish prolonged



Invertebrate prolonged

Tier1 Algae Mesocosm



L.

macrochirus Geomean P. promelas M. bahia Geomean M. bahia

S. subspicatus

Aquatic invertebrates, algae, macrophyte

RACsw,ac RACsw,ac RACsw,ch RACsw,ac RACsw,ac RACsw,ch RACsw,ch ETO-RAC

3.2 µg/L 8.04 µg/L 2.6 µg/L 0.19 µg/L 0.62 µg/L 0.14 µg/L 300 µg/L 0.59 µg/L

FOCUS Step 1 1760 550.00 218.91 676.92 9263.16 2838.71 12571.43 5.87 2983.05

FOCUS Step 2 575 179.69 71.52 221.15 3026.32 927.42 4107.14 1.92 974.58

FOCUS Step 3

D3 Ditch <1E-6 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

D4 Pond 0.4398 0.14 0.05 0.17 2.31 0.71 3.14 0.00 0.75

D4 Stream 0.3428 0.11 0.04 0.13 1.80 0.55 2.45 0.00 0.58

D6 Ditch 1 35.4 11.06 4.40 13.62 186.32 57.10 252.86 0.12 60

D6 Ditch 2 52.17 16.30 6.49 20.07 274.58 84.15 372.64 0.17 88.42

R1 Pond 0.3012 0.09 0.04 0.12 1.59 0.49 2.15 <0.0001 0.51

R1 Stream 27.56 8.61 3.43 10.60 145.05 44.45 196.86 0.09 46.71

R2 Stream 28.15 8.80 3.50 10.83 148.16 45.40 201.07 0.09 47.71

R3 Stream 136.2 42.56 16.94 52.38 716.84 219.68 972.86 0.45 230.85

FOCUS Step 4 (10m VBS)

D4 Pond 0.4398 0.14 0.05 0.17 2.31 0.71 3.14 <0.0001 0.75

D4 Stream 0.3428 0.11 0.04 0.13 1.80 0.55 2.45 <0.0001 0.58

D6 Ditch 1 35.4 11.06 4.40 13.62 186.32 57.10 252.86 0.12 60

D6 Ditch 2 52.17 16.30 6.49 20.07 274.58 84.15 372.64 0.17 88.42

R1 Stream 11.72 3.66 1.46 4.51 61.68 18.90 83.71 0.04 19.86

R2 Stream 12.82 4.01 1.59 4.93 67.47 20.68 91.57 0.04 21.73

R3 Stream 63.12 19.73 7.85 24.28 332.21 101.81 450.86 0.21 106.98

FOCUS Step 4 (20m

VBS) *

R1 Stream 5.982 1.87 0.74 2.30 31.48 9.65 42.73 0.02 10.14

R2 Stream 6.72 2.10 0.84 2.58 35.37 10.84 48.00 0.02 11.39

R3 Stream 32.57 10.18 4.05 12.53 171.42 52.53 232.64 0.11 55.2

Values in bold do not meet the trigger *Only R scenarios were refined with 20m VBS since entry route in D scenarios is drainage and no mitigation measures are available to reduce the contribution.



Effects on bees (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.1 and Regulation (EU) N° 284/2013 Annex Part A, point 10.3.1)*

* This section does reflect the new EFSA Guidance Document on bees which has not yet been noted by the Standing Committee on

Plants, Animals, Food and Feed.

Species Test substance Time scale/type of endpoint

End point

toxicity

Apis mellifera MOCAP 15G Acute (48h) Oral toxicity (LD50) 26.1 µg product/bee 4.07 µg a.s./bee

Apis mellifera MOCAP 15G Acute (48h) Contact toxicity (LD50) >100 µg product /bee >15.6 µg a.s./bee

Semi-field test (Cage and tunnel test) No further tests submitted

Field tests No further tests submitted

Risk assessment for bees from contact and oral dietary exposure for ethoprophos–

application to potato (pre-planting, broadcast and in-furrow application): 6 kg ethoprophos/ha

Species Test substance

Scenario Risk quotient

HQ/ETR Trigger

Screening step

Apis mellifera

ethoprophos Treated crop ETRoral 3.36 0.2 ethoprophos Guttation water ETRoral 3.9 0.2 ethoprophos Surface

water in-furrow

Step 1 HQoral 4929.73 0.2

Step 2 (SE, March-May) HQoral 1610.565

Step 3* - D6 Ditch 2 HQoral 146.127

Step 4* – 10m VBZ - D6 Ditch 2

HQoral 146.127

ethoprophos Surface water broadcast

Step 1 HQoral 4929.73 0.2

Step 2 (SE, March-May) HQoral 1610.565

Step 3* - D6 Ditch 2 HQoral 146.127

Step 4* – 10m VBZ - D6 Ditch 2

HQoral 146.127

ethoprophos Puddle water in-furrow

Step 3 - R1 HQoral 0.000034 0.2

Step 3 - R2 HQoral 0.000015


ethoprophos Puddle water

broadcast

Step 3 - R1 HQoral 0.0008 0.2



Tier 1

Apis mellifera

ethoprophos Foraging on treated crop ETRoral 0.018 0.2

ethoprophos Foraging on weeds in treated field ETRoral 0.16 0.2 ethoprophos Foraging on succeeding crop ETRoral 1.03 0.2 * See revised RAR Vol 3 CP9 for further information.

Effects on other arthropod species (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.3.2)

Laboratory tests with standard sensitive species

Species Test Substance

End point Toxicity

Poecilus cupreus MOCAP 20G Mortality, LR50 100% mortality at 7 kg a.s./ha



Aleochara bileneata MOCAP 20G Mortality, LR50 100% mortality at 10 kg a.s./ha

Additional species

None submitted

First tier for ethoprophos– application to potato (pre-planting, broadcast and in-furrow

application): 6 kg ethoprophos/ha

Test substance Species Effect (LR50 g/ha)

HQ in-field HQ off-field (1 m)

Trigger

Due to the lack of suitable endpoints from laboratory studies, the first tier risk assessment cannot be performed. However, due to the “nearly dust free” properties of the representative formulation, the off-field exposure is considered negligible, therefore the off-field risk is assessed as low. A high in-field risk cannot be excluded. Data from extended laboratory studies are considered not sufficient to demonstrate a potential for in-field re-

colonisation.

Extended laboratory tests, aged residue tests

Species Life stage Test substance, substrate

Time scale

Dose End point % effect (positive values = adverse effects)

Aleochara bileneata

Adult MOCAP 10G, soil application, aged residue 28 days and 86 days in outdoor conditions

28 d of exposure

110 kg product/ha (11 kg a.s./ha) initial application rate

reproduction

100 (28 d aged residues)

100 (86 d aged residues)

Poecilus cupreus

Adult MOCAP 10G, soil application, aged residue 30 days and 59 days in outdoor conditions

21 d of exposure


Mortality/ Food consumption

57/54 (30 d aged residues)

0/0 (59 d aged residues)

Aleochara bileneata

Adults MOCAP 10G, soil application, aged residue 6 days, 13 weeks, 23 weeks and 10.5 month under field conditions

28 d of exposure


Reproduction

100 mortality (6 d aged residues)

99 reproduction (13 w aged residues)

69.5 reproduction (23 w aged residues)

7.7 reproduction (10.5 m aged

residues)

Semi-field tests


Field studies

No acceptable field studies. Further information can be found in the revised RAR Vol 3 CP9

Additional specific test




Effects on non-target soil meso- and macro fauna; effects on soil nitrogen transformation (Regulation (EU) N° 283/2013, Annex Part A, points 8.4, 8.5, and Regulation (EU) N°

284/2013 Annex Part A, points 10.4, 10.5)

Test

organism

Test substance Application

method of

test a.s./

OM1

Time scale End point Toxicity

Earthworms

No suitable endpoint for earthworms. Data gap.

Other soil macro-organisms

Hypoaspis

aculeifer

MOCAP 15G Mixed in

artificial soil

/ 5% peat

Chronic (14d) Mortality,

reproduction

NOEC 13.25* mg

product/kg soil (1.99*

mg a.s./kg soil)

14-d EC10 9.68* mg


mg a.s./kg soil)

14-d EC20 17.56* mg


mg a.s./kg soil)

Folsomia

candida

MOCAP 15G Mixed in

artificial soil

/ 5% peat

Chronic (28d) Mortality,

reproduction

NOEC 0.026* mg

product/kg soil

(0.004* mg a.s./kg

soil)

28-d EC10 0.055* mg


mg a.s./kg soil)

28-d EC20 0.074* mg


mg a.s./kg soil) §effects on body weight were recorded at all the testes concentrations, endpoint not suitable for the risk assessment *endpoints divided by 2 due to the logPow>2 Endpoints in bold used in the risk assessment.

Higher tier testing (e.g. modelling or field studies)

Field studies were not considered acceptable during the Experts’ consultation for refinement. For further

information, see revised RAR Vol 3 CP9.

Nitrogen transformation Ethoprophos <25% effect at day 44 at 33.33 mg a.s./kg d.w.soil

(25 kg a.s/ha)*

*Endpoint based on concentration of nitrogen in soil (expressed as NH4+, NO3

-, NO2- per kg dry soil) and not in terms

of nitrate transformation rate.



First tier risk assessment for ethoprophos– application to potato (pre-planting, broadcast and in-furrow application): 6 kg ethoprophos/ha

Test organism Test substance Time scale Soil PEC (actual)

TER Trigger

Earthworms

No Tier 1 risk assessment (no acceptable endpoint).

Other soil macroorganisms

Hypoaspis aculeifer

Ethoprophos Chronic 2.67 0.54 5

Folsomia candida Ethoprophos Chronic 2.67 0.0015 5

Effects on terrestrial non target higher plants (Regulation (EU) N° 283/2013, Annex Part A,

point 8.6 and Regulation (EU) N° 284/2013 Annex Part A, point 10.6)

Screening data

Pre-emergence applications of ethoprophos at a rate equivalent to 2.2 kg a.s./ha caused an adverse effect on

the growth of 8 out to the 22 plant species tested. At rates below 2.2 kg a.s./ha, no adverse effects were

observed. Post-emergence applications virtually had no adverse effects on plants

Laboratory dose response tests - ethoprophos– application to potato (pre-planting, broadcast and in-furrow application): 6 kg ethoprophos/ha

Species Test substance ER50 (g a.s./ha)

vegetative vigour

ER50 (mL f.p./ha) emergence

Exposure (g a.s./ha)

TER Trigger

No studies submitted. The representative product is a granular formulation dust free, no agreed risk assessment scheme for exposure of the off-crop available.

Extended laboratory studies : Not necessary Semi-field and field test: Not necessary

Effects on biological methods for sewage treatment (Regulation (EU) N° 283/2013, Annex

Part A, point 8.8)

Test type/organism end point

Activated sludge 3-hour EC50 =780 mg/L (respiration activity)

Monitoring data (Regulation (EU) N° 283/2013, Annex Part A, point 8.9 and Regulation (EU) N° 284/2013, Annex Part A, point 10.8)

Available monitoring data concerning adverse effect of the a.s.

No data available

Available monitoring data concerning effect of the PPP.

No data available

Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A, point

7.4.2) Ecotoxicologically relevant compounds1

Compartment

soil Ethoprophos, tentative for other metabolites



Surface water Ethoprophos, tentative for other metabolites

sediment Ethoprophos

groundwater Ethoprophos, tentative for other metabolites 1 metabolites are considered relevant when, based on the risk assessment; they pose a risk comparable or higher than the parent



Classification and labelling with regard to ecotoxicological data (Regulation (EU) N° 283/2013, Annex Part A, Section 10)

Substance Ethoprophos





Aquatic Acute 1 – H400

Aquatic Chronic 1 - H410

Peer review proposal10 for harmonised classification


Aquatic Acute 1 – H400 (M=10)

Aquatic Chronic 1 - H410 (M=10)

9 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and

packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.


appendix a list of end points for the active substance and

Documents