1. identification of chemicals and information on a ...etg-group.org/docs/ecodis/msds_2013_pages...
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Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 1
Safety Data Sheet registration number №
Valid until
page. 3
out of 20
1. Identification of chemicals and information on a manufacturer and/or supplier
1.1. Identification of chemicals
1.1.1. Technical name: Disinfecting substance BIOPAG [1].
1.1.2. Brief recommendations on application
(incl. application restrictions)
Desinfecting substance BIOPAG is intended for
application as an active agent in manufacturing process
of disinfectants [1].
1.2. Information on a manufacturer and/or supplier
1.2.1. Developer
1.2.1.1. Full official name of the organisation: Regional public organisation– Institute of
Ecotechnologies (short name: RPO IETP).
1.2.1.2. Postal address: Volzhskiy boulevard 113A, Moscow, 109462, Russia
1.2.1.3. Telephone (including emergency
cunsultations) and time limitations:
+7 (495) 921-43-61, from 9:00 to 17:00
1.2.1.4. Fax: +7 (495) 921-43-61
1.2.1.5. Е-mail: [email protected]
1.2.2. Manufacturer
1.2.2.1. Full official name of the organisation: Limited liability company «International Institute of
Ecotechnologies» (short name: LLC «MIETP»).
1.2.2.2. Postal address: Electrolitniy proezd 9 bld.1, Moscow, 117638, Russia
1.2.2.3. Telephone (including emergency
cunsultations) and time limitations:
+7 (495) 921-43-61, from 9:00 to 17:00
1.2.2.4. Fax: +7 (495) 921-43-61
1.2.2.5. Е-mail: [email protected]
2. Hazard identification
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Disinfecting substance «Biopag»
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2.1. Hazard class of chemicals in general:
(information on hazard classification in accordance
with the legal system of the Russian Federation
(GOST 12.1.007) and GHS (after confirmation))
In accordance with the acute toxicity parameters in the
classification GOST 12.1.007-76 BIOPAG substance
attributes to the 3th
class of moderately hazardous
substances when introduced into stomach, to the 4th
class
of low-hazard substances in case of a skin contact and to
the 4th class of low-toxic substances when inctroduced
into abdominal cavity. BIOPAG substance does not have
any sensitising or cumulative effect. When inhalating
vapours are low-hazard. The substance has a local
irritating effect when applied once on skin or eyes.
[Ошибка! Источник ссылки не найден., 37].
2.2. Hygienic normatives for products in general in
workspace area:
(MACwa. or Safe Reference Level of Impact
in workspace area)
MACwa – 2 mg/m3, aerosol, 3rd hazard class, a special
protection for skin and eyes is required [Ошибка!
Источник ссылки не найден., 37].
2.3. Information on labeling (according to GOST 31340-07)
2.3.1. Hazard description: Signal word: Be careful. Danger symbols: Exclamation
mark. - Harmful if swallowed (oral) [34].
- Causes serious eye irritation in the case of eye contact
[34].
2.3.2. Preventive measures: - Do not smoke, drink or eat when using product [34].
- Wash hands after working with product [34].
Emergency procedures:
- If swallowed, rinse mouth and immediately seek
medical help [34].
- After working with product wash hands with soap [34].
- Use rubber or plastic gloves according to GOST
20010-93 [34].
- Use eye protection means – eye-protective goggles of a
trade mark ZN with colourless glasses according to
GOST 12.4.013-97 [34].
- In the case of an eye contact, carefully wash eyes with
water for several minutes. Take contact lenses off, if any
and it is not difficult to do. Keep washing eyes [34].
- Seek medical assistance if irritation does not go away
[34].
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 1
Safety Data Sheet registration number №
Valid until
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3. Composition (information on components)
3.1. Information on the product in general
3.1.1. Chemical name:
(according to IUPAC)
Poly (iminocarbonimidoylimino-1,6-hexandiyl)
hydrochloride
3.1.2. Chemical formula: Empirical formula: (C7H16ClN3)n, where n=5-50 [1].
Structural formula:
(CH2)6NH C NH
NH HCl n., where n=5-50
[1].
3.1.3. General characteristics of the composition:
(taking to the account brand assortiment, with an
indication of admixtures and functional additives
that have an effect on hazard of productsопасность
продукции; methods of production)
«Disinfecting substance «BIOPAG» where there is not
more than 95% of polyhexamethyleneguanidine
hydrochloride, the rest to 100% is water [1] is called
«solid form».
Disinfecting substance BIOPAG can be manufactured as
a water solution of polyhexamethyleneguanidine
hydrochloride («liquid form») with its content up to 25%
under trade marks «Disinfecting substance
«Biopag-D» according to the technical specification TU
9392-020-41547288-02 [38], «Antimicrobial preparation
«Biopag» according to TU 9392-009-41547288-2000
[39].
3.2. Components
(name, CAS and EC numbers (if any), mass share,
MACwa or SRLIwa, hazard classes, refeences on data
sources)
Components
(name, CAS and EC numbers)
Mass share, % MACwa,
mg/m3
Hazard class Information
sources «Liquid
form»
«Solid
form»
Poly
(iminocarbonimidoylimino-
1,6-hexandiyl) hydrochloride
(polyhexamethyleneguanidine
hydrochloride, polyhexa-
iminoimidocarbonimono-
hexamethylene hydrochloride,
short name: PHMGHC)
CAS № 57029-18-2
20 ± 1,5 Not less
than 95%
2 mg/m3 for
substance in
aerosol form
3rd class of moderately
hazardous substances when
introduced into stomach, 4th
class of low-hazard
substances in the case of
skin contact
[1,
Ошибка!
Источник
ссылки не
найден., 37,
38, 39].
Water The rest to 100% - -
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TU 9392-008-41547288-00 with changes № 11
4. First aid measures
4.1. Observable symptoms
4.1.1. In case of respiratory exposure (inhalation): Vapours of BIOPAG substance in a «solid form» and as
a water solution do not have any general toxic or
irriteting effect on a human being [33].
In the case of respiratory exposure (aerosol inhalation)
cough, throat irritation or respiratory affection may be
observed. [Ошибка! Источник ссылки не найден.].
4.1.2. In case of skin exposure: In case of skin contact the product in a powder form
may have a low local irritating effect (in the case of a
single contact); water solution of the product may cause
first signs of local irritating action on the skin which
may appear after multiple contacts (at least three
applications). Intensity and severity of this action
depend on the concentration of the product [Ошибка!
Источник ссылки не найден.].
4.1.3. In case of eye exposure: In case of eye contact with the powder form of the
product a pronounced irritation, plethoric eye watering,
blepharospasm, edema, mucopurulent excrements,
leucoma formation or loss of vision may be observed. In
the case of eye contact with water solution of the
product eye watering, pronounced irritation or edema
may be observed, while they do not cause keratopathy
or loss of sight [Ошибка! Источник ссылки не
найден.].
Irritating effect on eye mucous tunics depends on
percentage composition of the active agent in water
solution. The effect may be from low to the pronounced
one [Ошибка! Источник ссылки не найден.].
4.1.4. In case of oral exposure (if swallowed): In case of oral exposure (if swallowed) breathing
problems, dystaxia, convulsions, cyanosis of mucous
membranes or skin may be observed [Ошибка!
Источник ссылки не найден.].
4.2. First aid measures
4.2.1. In case of inhalation poisoning: Inhalation poisoning with product vapours is
unlikely.[Ошибка! Источник ссылки не найден.].
Fresh air, warmth and repose. Seek medical assistance if
necessary [Ошибка! Источник ссылки не найден.].
4.2.2. In case of skin exposure: Wash skin with running water and soap. Seek medical
assistance if necessary [Ошибка! Источник ссылки
не найден., 37].
4.2.3. In case of eye exposure: Immediately wash eyes with running water during 10-15
minutes, then drop 30 % solution of sodium sulfacyl.
Disinfecting substance «Biopag»
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Seek medical assistance if necessary [37].
4.2.4. In case of oral poisoning: Drink several glasses of water with adsorbent (10-20
crushed tablets of activated carbon per 1 glass of water).
Do not cause vomiting. Seek medical assistance if
necessary [Ошибка! Источник ссылки не найден.,
37]. Take salt laxative. [Ошибка! Источник ссылки
не найден.].
4.2.5. Contraindications: Do not cause vomiting [32, 37].
4.2.6. First aid equipment (first aid kit): Cotton wool, glass bath for eye washing, 30 % solution
of sodium sulfacyl, activated carbon, salt laxative
[Ошибка! Источник ссылки не найден.].
5. Measures and tools for prevention of fire and explosion hazard
5.1. General characteristics of fire and explosion
hazard:
The product is manufactured in granules that do not
form any dusty explosive mixtures [1].
The product is fire- and explosion-proof.
Ignition temperature: 400оС [Ошибка! Источник
ссылки не найден.].
Self-ignition temperature: 455 оС [Ошибка!
Источник ссылки не найден., Ошибка! Источник
ссылки не найден.].
5.2. Parameters of fire and explosion hazard:
(nomenclature of indicators according to GOST
12.1.044 and GOST R 51330.0)
Inflammability class: combustible, low flammable [5,
Ошибка! Источник ссылки не найден.].
Flash temperature is more than 400 оС [Ошибка!
Источник ссылки не найден.].
5.3. Hazard of combustion and/or decomposition
products:
Combustion products: carbon oxides, nitrogen oxides,
hydrochloride [Ошибка! Источник ссылки не
найден.].
Poisoning with a carbon monoxide causes headache,
dizzinness; buzzing in ears, breathlessness, heartbeating,
flickering before eyes, facial flushing, general faintness,
sickness, sometimes vomiting; in severe cases
convulsions, loss of consciousness, coma [36].
Depending on a content of various nitrogen oxides in
gas mixtures poisoning with nitrogen oxides in general
has irritating or nitrite action. After a contact of nitrogen
oxides with wet surfaces of lungs HNO3 and HNO2 are
formed. They attack alveolar tissue that cause
pulmonary edema and complex reflectory problems.
Nitrates and nitrites are formed in blood and cause
vessel distensibility, lack of oxygen and fall of blood
pressure [40].
In the case of high concentrations poisoning with
hydrochloride causes irritation of mucous tunics,
especially nasal; conjuctivitis; corneal opacity,
hoarseness, choking feeling, chest tingling, snuffles,
cough. Chronic intoxication causes catarrh of the
respiratory tract, dental decay, cankering of nasal
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mucous tunics, gastroenteric upsets [40].
5.4. Recommended fire extinguishing substances: Aspirated foam, water[37].
In case of inflammation use sand, felt mat, asbestos
cloth, fire extinguishers of types ОП (lat. OP), ОУ (lat.
OU) [Ошибка! Источник ссылки не найден.,
Ошибка! Источник ссылки не найден.].
5.5. Forbidden fire extinguishing substances: None [Ошибка! Источник ссылки не найден.,
Ошибка! Источник ссылки не найден., Ошибка!
Источник ссылки не найден.].
5.6. Personal protection equipment (PPE) for fire
fighters and personnel
For a work manager– ПДУ-3 (lat. PDU-3) (during 20
minutes). For emergency brigades – an isolating
protective suit КИХ-5 (lat.KIH-5) complete with an
isolating gas mask ИП-4М (lat. IP-4M) or a breathing
apparatus АСВ-2 (lat.ASV-2). In the case of
inflammation – a fireproof suit complete with a self-
rescue device СПИ-20 (lat.SPI-20). If there is no such
an equipment – an all-service protective suit Л-1 (lat.L-
1) or Л-2 (lat. L-2) complete with an industrial gas mask
with cartridges of B type with an aerosol filter, small
box respirator. When concentrations in the air are low
(if MAC is up to hundredfold higher) – work clothes, an
industrial gas mask of a small size ПФМ-1 (lat.PFM-1)
with a universal protective cartridge ПЗУ (lat.PZU), an
independent protective individual set with a forced feed
of purified air to a breathing zone. Oil-and-petrol
resistant gloves, gloves made by dispersion of butyl-
rubber, special shoes [Ошибка! Источник ссылки не
найден., Ошибка! Источник ссылки не найден.].
5.7. Specific instructions for fire fighting: Wear protective clothes and use a breathing apparatus
before entering the zone of an accident. Extinguish fire
with sprayed water, air or chemical foam standing at a
maximum possible distance from a burning product. Do
not come too close to the product. Precipitate fire gases
and vapours with fine-sprayed water. Organise
evacuation of people from buildings that are situated
nearby taking to the account the direction of flowing of
toxic combustion products [6].
Pour water on containers with product located in the
vicinity of the fire area while standing possibly remote
from the containers in order to cool them. This is
required for prevention of product firing, as well as its
melting down and losing of its marketable condition (the
product has a low melting point - 120°С) [Ошибка!
Источник ссылки не найден.].
6. Measures for prevention and elimination of accidents and their consequences
6.1. Measures for prevention of harmful influence on people, environment, buildings, etc. in emergency
situations
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 1
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6.1.1. Required general recommendations: In a case of an emergency an executive officer is chief
engineer of a plant. A chief of a workshop where an
accident has happenned becomes responsible for all the
works for mitigation of the emergency. A chief of a shift
that was working when the accident has happenned
should immediately by himself or by responsible
subordinates call a gas safety or a fire brigade and notify
an on-duty dispatcher of the plant about the accident.
The responsibilities of foremen and equipment
workshop operators where the accident has happenned
include an immediate notification of a plant dispatcher
about the accident and taking measures for men
removing from work rooms.
In the case of an emergency alert (alarm, honk, ring) all
the workers except people who are participating in the
mitigation of the emergency in the workshop
(department, segment) must leave their work rooms and
follow a predetermined way to the emergency exits
[Ошибка! Источник ссылки не найден.].
People who are participating in emergency containment
should fulfil all the works using personal protective
equipment (wear work clothes according to GOST
12.4.031-84, protective goggles according to GOST
12.4.013-85, rubber or plastic gloves according to
GOST 20010-93) [1, 37].
6.1.2.Personal protective equipment:
(for emergency brigades and personnel)
See Clause 8.3. In the case of an emergency spillage all
the works should be fulfilled using personal protective
equipment: work clothes, rubber gloves, dust masks
[37], for protection of eyes protective goggles of a brand
ЗН (lat. ZN) with colourless glasses should be used [1,
Ошибка! Источник ссылки не найден., 13, 14,
Ошибка! Источник ссылки не найден.].
6.2. Measures for mitigation of emergencies
6.2.1. Emergency measures in case of spillage,
leakage or scattering of the product:
(including safety precautions that provide
environmental protection)
Scattered substance should be gathered and sent for
utilisation. Residuals should be washed out with water.
Solutions that contain the substance can be poured into
drains only when diluted.
In the case of an accidental scattering cleaning can be
carried out only in work clothes, respiratory organs
should be protected with antidust respirators, hand skin -
with rubber gloves, eyes – with hermetical goggles.
It is allowed to work with the product only if workers
are older than 18 and they do not suffer from a
hypersensibility to chemicals or medicines or any
allergic desease.
If product is in an undamaged package, it should be
gathered and sent for the purpose intended [37].
6.2.2. Emergency measures in case of fire: In the case of fire a fire brigade should be called
immediately, an on-duty dispatcher should be notified
about the fire and measures for removing people from
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their work places should be takes and the fire should be
mitigated.
Do not come to close to the burning product.
If the fire is detected all the workers from this shopfloor
should immediately use personal protective equipment
(a filtering gas mask) and leave their work rooms,
following the predetermined way to the emergency
exits. [Ошибка! Источник ссылки не найден.].
7. Safe storage and handling conditions for chemicals while loading-unloading operations
7.1. Protective measures when handling chemicals
7.1.1. Protective measures and collective protective
equipment:
(including measures for fire and explosion safety)
Avoid ingress of the substance into respiratory organs,
on skin, on mucous tunics of eyes, into stomach.
It is allowed to work with the substance (weigthing,
preparing of working solutions) only in work clothes,
respiratory organs should be protected with antidust
respirators, hand skin– rubber gloves, eyes – hermetical
goggles [37].
The product is fire- and explosion- safe, flash point is
more than 400°С [Ошибка! Источник ссылки не
найден., 37].
Support peronnel should be instructed with the labour
safety rules when working with the product and
provided with personal protective equipment [1, 13]. It
is not allowed to work with the product near the open
fire or heat sources. Take fire precautions[10].
7.1.2. Measures for environmental protection: Environmental protection is achieved by observance of
standards of technological regulations, encapsulation of
technological equipment and transport tare.
In industrial premises and the most essential work
places periodical control for the condition of the air in
the workspace area should be carried out [Ошибка!
Источник ссылки не найден., 9].
Solutions that contain the substance can be poured into
drains only when diluted. [37].
Do not allow the substance to get into ground and
surface waters in amounts that exceed maximum
allowed concentrations (MAC) [24, Ошибка!
Источник ссылки не найден.].
There are no wastes that are subject to a special disposal
at a stage of product preparation [1].
7.1.3. Recommendations on a safe transportation: Freight is non-hazardous [18].
The product can be transported by all modes of
transport, in roofed vehicles in conditions that
guarantee safety of package, in compliance with the
rules that are effective on each mode of transport.
In order to prevent scattering of the product avoid tare
tampering (shocks or heating) [1, 37].
7.2. Storage conditions of chemicals
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7.2.1. Conditions and time limits of safe storage:
(including guaranteed shelf life)
The product should be stored in hermetically sealed
producer’s containers in dry roofed indoor storage
facilities on wooden shelving or trays at the ambient
temperature from –40 оС to +40
оС.
Guaranteed shelf life is 7 years.
The substance should be stored apart from food products
and medicines in places not available for children [1,
37].
7.2.2. Substances and materials that are
incompatiable with the product when storing:
Oxidants, acids, alcali [Ошибка! Источник ссылки
не найден.]. The product should be stored apart from
food products and medicines in places not available for
children [1].
7.2.3. Materials that are recommended for tare and
packaging:
The substance is produced and packed in double-walled
polyethylene (PE) packages from 5 g to 10 kg according
to GOST 10354 [42] and hermetically sealed by fusion
welding. The PE film thickness is at least 0.6 mm. The
plastic packages are packed into transport tare:
corrugated paperboard, paper or PE sacks. It is
permissible to package the product into hermetically
sealed PE containers [1, 12, 37].
7.3. Safety precautions and storage conditions in
household use:
The product should be stored in hermetically sealed
producer’s containers at the ambient temperature from
from –40 оС to +40
оС. Shelf life is 7 years.
The product should be stored apart from food products
and medicines in places not available for children [1,
37].
8. Techniques of control for hazardous exposure and personal protective equipment
8.1. Parameters of working zone that are subject of
compulsory control (MACwa or SRLIwa):
MACwa – 2 mg/m3, aerosol, 3rd class of hazard, special
protection of skin and eyes is required [Ошибка!
Источник ссылки не найден.].
8.2. Measures for holding hazardous substances
content in permissible concentrations:
Observe all the safety precautions when working with
the product. Working premises should be equipped with
a communal combined extract and input ventilation and
local ventilation. Maintain hermecity of the equipment.
Control content of polyhexamethyleneguanidine
hydrochloride in the air of working area [8, 9].
8.3. Personal protective equipment
8.3.1. General recommendations: Working with the substance (weighting, preparation of
working solutions) should be carried out only in work
clothes, respiratory organs should be protected with
antidust respirators, hand skin – with rubber gloves,
eyes – with hermetical goggles.
It is prohibited for people who are younger than 18
years with a hypersensibility to chemicals and medicines
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or who are suffering from any allergic desease to work
with the product. [37].
8.3.2. Protection of respiratory organs (types of
personal protective equipment of respiratory
organs):
Antidust respirators according to GOST 12.4.034-2001
[37, 15].
8.3.3. Protective clothes (material, type): Protective goggles according to GOST 12.4.013-85 [1,
37, 14].
Rubber gloves according to GOST 20010-93 [1, 37, 41].
Work clothes according to GOST 12.4.031-84 [1, 37,
13].
8.3.4. Personal protective equipment in household
use:
All the works with the product should be carried out
with hand skin protected with rubber gloves, respiratory
organs - with respirators, eyes - with hermetical goggles
[37, 1].
9. Physicochemical properties
9.1. Physical conditions:
(state of aggregation, colour, odour)
BIOPAG is a transparent glass-like solid substance,
from colourless to light yellow colour (in lumps or fine
crushed – «solid form»), when crushed – it is a powder
from white to light yellow colour that contains small
pieces of solid transparent substance. [37]. Odourless
[Ошибка! Источник ссылки не найден.], contains
not less than 95% of polyhexamethyleneguanidine
hydrochloride.. [1, 37].
9.2. Parameters characterizing basic properties of
chemicals, primarily hazardous:
(temperature indices, pH, solubility, coefficient n-
octanol/water, etc.)
Softening point: > 100 °С [Ошибка! Источник
ссылки не найден.].
Melting point: 120 °С [Ошибка! Источник ссылки
не найден.].
Density at 20C, g/cmЗ: ~1,0 [Ошибка! Источник
ссылки не найден.].
Water-solubility: soluble [1].
Alcohol- solubility: soluble [Ошибка! Источник
ссылки не найден.].
Thermal degradation temperature: 250 оС.
Inflammability class (fire risk): combustible, low-
flammable [Ошибка! Источник ссылки не
найден., 5, Ошибка! Источник ссылки не
найден.].
Ignition temperature: 400 оС [Ошибка! Источник
ссылки не найден.].
Self-ignition temperature: 455 оС [Ошибка!
Источник ссылки не найден.].
10. Stability and reacting capacity
10.1. Chemical stability:
(for non-stable products decomposition products
should be mentioned)
The product is stable in normal conditions of storage
and handling. The product is stable in abiotic conditions
[Ошибка! Источник ссылки не найден.].
Disinfecting substance «Biopag»
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10.2. Reacting capacity: The product can be oxidized, alkylated or acidified [4].
10.3. Conditions that should be avoided:
(including hazard expressions upon contact with
incompatible substances and materials)
Incompatible with oxidants, acids, alkali or open fire
[Ошибка! Источник ссылки не найден.].
11. Information on toxicity
11.1. General characteristics of exposure:
(evaluation of hazard (toxicity) of exposure on
organisms)
In accordance with the acute toxicity parameters in the
classification GOST 12.1.007-76 BIOPAG substance
attributes to the 3th
class of moderately hazardous
substances when introduced into stomach, to the 4th
class of low-hazard substances in case of skin contact
and to the 4th
class of low-toxic substances when
introduced into abdominal cavity. BIOPAG substance
does not have any sensitising or cumulative effect.
When inhalating vapours are low-hazard. The substance
has a local irritating effect when applied once on skin or
eyes [37].
The BIOPAG substance attributes to the 4th
class of low
hazard substances according to the volatility level
[Ошибка! Источник ссылки не найден.].
No signs of irritating action of the substance on mucous
tunics of upper airway in conditions of saturating vapour
concentrations were found. An irritating effect was
detected when inhalating aerosol. [26].
11.2. Ways of exposure:
(inhalational, peroral, skin and eye contact)
Inhalational, peroral, skin and eye contact [Ошибка!
Источник ссылки не найден., Ошибка! Источник
ссылки не найден., 33].
11.3. Affected organs, tissues and systems of a
human being:
Central nervous and respiratory systems, hepar, kidneys,
morphological composition of peripheral blood, eyes,
skin, carbohydrate and protein metabolism, oxidation-
reduction processes [Ошибка! Источник ссылки не
найден.]. Local irritating action on skin and mucous
tunics of eyes depends on percentage composition of the
active agent in water solutions. The reaction on it that
may be from low to an expressed one [Ошибка!
Источник ссылки не найден.].
11.4. Information on dangerous to health exposures
upon direct contact with the substance as well as
consequences of these exposures: (irritating action on upper airways, eyes, skin,
including skin-resorbtive action; sensibilisation)
In conditions of saturating vapour concentrations, the
substance does not have any irritating action on mucous
tunics of the upper airways.[26].
The substance causes irritation of mucous tunics of eyes.
In the case of a skin contact may cause a local irritating
effect.
The substance does not have any sensibilising effect
[Ошибка! Источник ссылки не найден.].
11.5. Information on hazardous late effects of an exposure on organisms:
Cumulative properties are poorly marked [Ошибка!
Источник ссылки не найден.].
page 14
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Safety Data Sheet registration number №
Valid until
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 11
(influence on a reproduction function,
carcinogenecity, cumulativeness, etc.) The substance did not show any embryotoxic,
gonadotrophic, mutagenic and cancerogenic action in
experiments with animals [Ошибка! Источник
ссылки не найден., 33].
11.6. Acute toxicity parameters:
(DL50, route of entry (intragastrically, skin
application), animal specimen;
CL50, time of exposure (h), animal specimen)
DL50 – 1080 mg/kg, intragastrically, rats [Ошибка!
Источник ссылки не найден.].
DL50 – 906 mg/kg, intragastrically, mice [Ошибка!
Источник ссылки не найден.].
DL50 – 10500 mg/kg, skin application, rats, mice
[Ошибка! Источник ссылки не найден.].
СL50 is unreachable [Ошибка! Источник ссылки не
найден.].
11.7. Doses (concentrations) that have a minimal
toxic effect:
Threshold chronic effect:
Limcrcut
, mg/kg: 8 (rats) [Ошибка! Источник ссылки
не найден.].
Threshold acute effect:
Limacсut
, mg/kg: 1000 (rats) [Ошибка! Источник
ссылки не найден.].
Threshold of an irritant action on a rabbits’ skin
Limir – 20%, skin application, once [Ошибка!
Источник ссылки не найден., Ошибка! Источник
ссылки не найден.],
Limir – 1%, skin application, repeatedly [Ошибка!
Источник ссылки не найден., Ошибка! Источник
ссылки не найден.].
Threshold of an irritant action on mucous tunics of
rabbits’ eyes:
Limir -1%, eyes, once [Ошибка! Источник ссылки
не найден., Ошибка! Источник ссылки не
найден.].
12. Information on an environmental impact
12.1. General characteristics of exposures on
environmental objects:
(open air, water basins, ground)
Stable product in abiotic conditions. The substance
transforms in the environment. It has an effect on
organoleptic properties of water [Ошибка! Источник
ссылки не найден.].
12.2. Ways of exposure on the environment: In the case of infringement of rules of handling,
transportation, storage, accidents and emergency
situations [16].
12.3. Observable signes of exposure: If the concentrations are high, it has a negative effect on
growth and development of aquatic saprophytic
microflora and causes a slowdown of biochemical
oxygen consumption. It also causes foam formation
[33].
12.4. The most important characteristics of exposure on the environment
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 1
Safety Data Sheet registration number №
Valid until
page. 15
out of 20
12.4.1. Hygienic normatives:
(permissible concentrations in the open air, water, including
fishery water bodies, ground)
Componenets MAC open air.
or SRLI open
air, mg/m3
MAC water1
or APC water,
mg/l,
MAC fishery
water bodies.2
or SRLI
fishery water
bodies,
mg/l
MAC ground or
APC
ground,
mg/kg
Sources of data
Poly
(iminocarbonimidoylimino-
1,6-hexandiyl) hydrochloride
(polyhexamethyleneguanidine
hydrochloride, polyhexa-
iminoimidocarbonimono-
hexamethylene
hydrochloride, short name:
PHMGHC)
SRLIopen air
0.03 mg/m3
MAC water
0.1 mg/l,
general, 3
class of
hazard
MAC fish.bod.
0.01 mg/l,
sanitary-
toxicological,
3 class of
hazard
None [Ошибка!
Источник
ссылки не
найден.,
Ошибка!
Источник
ссылки не
найден., 24,
Ошибка!
Источник
ссылки не
найден.,
Ошибка!
Источник
ссылки не
найден.]
Water - - - -
12.4.2. Ecotoxicity indices:
(CL, EC for fishes, Daphnia magna,algae, etc.)
Toxicity for fishes:
Acipenser Linne/CL50 (96 h): 10.0 mg/l
[Ошибка! Источник ссылки не найден.],
Leuciscus idus/CL50 (96 h): 4.17 mg/l
[Ошибка! Источник ссылки не найден.].
Other aquatic invertebrates:
Daphnia magna/CL50 (48 h): 1.0 mg/l [Ошибка!
Источник ссылки не найден.].
Water plants:
Scenedrsmus quadricanda/EC50 (72 h): 1.0 mg/l
[Ошибка! Источник ссылки не найден.].
12.4.3. Migration and transformation in the environment due
to biodestruction and other processes (oxidation, hydrolysis,
etc.):
PHMG-H is quite a stable compound in the
water environment. If the concentrations are
higher than 1.0-1.5 mg/l, it intensifies water
foam formaation. It does not give water any
foreign odours, tastes or colours. If the
concentrations are higher than 0.1 mg/l, it does
not have any effect on processes of natural self-
purification of water bodies. If the
concentrations are high, it may have a negative
effect on growth and development of aquatic
saprophytic microflora and cause a slowdown of
1 Water from water bodies for household and drinking and cultural and general water use
2 Water from water bodies that have a commercial fishing importance (including seas)
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Safety Data Sheet registration number №
Valid until
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 11
biochemical oxygen consumption. [33].
13. Recommendations on waste disposal (residuals)
13.1. Protective measures when handling with wastea that
are formed during application, storage, transportation, etc.
Avoid penetration of substance wastes to the
respiratory organs, on skin, mucous tunics of
eyes, into stomach.
It is allowed to work with the substance wastes
and residuals only in work clothes, respiratory
organs should be protected with antidust
respirators, hand skin– rubber gloves, eyes –
hermetical goggles [37].
All the workers should know all the safety rules
when working with the produc and provided
with personal protective equipment [1, 13].
It is prohibited for people who are younger than
18 years with a hypersensibility to chemicals and
medicines or who are suffering from any allergic
desease to work with the product. [37].
Follow fire precautions. [10].
It is allowed to work with the product only for
personnel who have completed safety induction,
education and knowledge assessment on safe
working practice with the product [11].
13.2. Information on places and methods of deactivation,
utilisation and substance waste disposal (material), including
tare (package):
Wastes of pure product should be gathered to a
container and put back to the technological
process for further application [17].
Scattered substance wastes should be gathered
and sent for utilisation. Residuals should be
washed out with water. Solutions that contain
the substance can be poured into drains only
when diluted [37].
There are no residuals that are due to a special
deactivation and disposal at the stage of product
production [1].
13.3. Recommendations on disposal of wastes that are
formed when applying of products in the household use:
It is recommended to wash the empty tare from
used product before utilisation. Residuals of
unused product should be diluted and poured
into drains [37].
14. Information on transportation
14.1. UN number:
(in compliance with UN recommendations for transportation
of dangerous goods (standard rules), the latest version)
There is no UN serial number.
14.2. An appropriate shipping and/or transport name: «Disinfecting substance «BIOPAG» (active agent) TU 9392-008-41547288-2000 with
changes to TU № 1 [1], «Desinfectant
«BIOPAG-D» TU 9392-020-41547288-02 [38],
Antimicrobial preparation «BIOPAG» TU 9392-
009-41547288-2000 [39].
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 1
Safety Data Sheet registration number №
Valid until
page. 17
out of 20
14.3. Modes of transport that can be used: The product can be transported by all modes of
transport, in roofed vehicles in conditions that
guarantee safety of package, in compliance with
the rules that are effective on each mode of
transport [1, 37].
14.4. Classification of freight hazard:
(according to GOST 19433 and UN recommendations on
transportation hazard)
The product is a non-hazardous freight [1, 18, 37].
14.5. Transport labelling:
(handling symbols; basic, additional and explanatory texts)
«Keep dry» [20]. The following information should be written on the label: name of the
product and a producer, a lot number, netto
weight, content of the active agent, date of
production, shelf life, indication of technical
specification TU [20].
14.6. Packaging groups:
(in compliance with UN recommendations on transportation
hazard)
None.
14.7. Information on hazard when transporting by car: None, as substances with a low level of hazard should be transported by car without application
of system of information on hazard [18].
14.8. Emergency cards:
(in case of railway, marine and other transportation)
None.
14.9. Information on hazard at the international freight
traffic: (according to Agreement on International Goods
Transport by Rail, ADR, RID, IMDG Code, ICAO/IАTA,
etc., including information on hazard for the environment
including information about a «marine pollutant»)
None.
15. Information on national and international legislation
15.1. National legislation
15.1.1. Laws of the Russian Federation: In any case one should act in compliance with
the effective legislation of the Russian
Federation.
15.1.2. Documents regulating requirements on
protection of human being and the environment:
(certificates, Hygiene Certificates, licences, etc.)
State Registration Certificate for disinfecting
substance (active agent) «BIOPAG» №
RU.77.99.01.002.E.002182.10.10 dated
26.10.2010 [27], State Registration Certificate of
the desinfecting substance «BIOPAG-D» dated
05.10.2010 № RU.77.99.01.002.E.001633.10.10
[44], State Registration Certificate of the
desinfecting substance Antimicrobial preparation
«BIOPAG» № RU77.99.88.002.E.007468.03.11
dated 25.03.2011 [45].
page 18
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Safety Data Sheet registration number №
Valid until
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 11
15.2. International legislation
15.2.1. International сonventions and agreements:
(if the products are regulated by the Montreal Protocol, the
Stokholm Convention, etc.)
Not regulated.
15.2.2. Safety marking that is effective in the EU countries:
(danger symbols, risk and safety phrases, etc.)
Danger symbols: Xi – irritation
R-phrases:
R21/22 – dangerous in the case of skin contact
or if swallowed.
S-phrases
S22 – not to inhale powder.
S26 – in the case of eye contact immediately
wash them with water during 15 minutes.
S28 – in the case of skin contact wash it with
water.
S48 – if the product is swallowed immediately
seek medical help and show them an instruction
or a package.
16. Additional information
16.1. Informaion on revision (reedition) of MSDS:
(it is written: «MSDS is first-time elaborated » or other cases
with an indication of the main argument for revision of
MSDS)
MSDS was registered with a Safety Data Sheet
Registration number № 41547288-93-19816
dated 20 August 2008, was revised due to the
end of its effective date 20 August 2013 [35].
16.2. List of data sources that were used while preparing MSDS
1. TU (technical specifications) 9392-008-41547288-00 «Desinfecting substance «BIOPAG» with
changes 1.;
2. Report made by FGUE Research Disinfectology Institute of Rospotrebnadzor of the Russian
Federation «Reasons for maximum allowed polyguanidine levels when applied on skin». – Moscow.
2005. (RPO IETP is the holder of the document);
3. Explosion and fire hazard of materials and substances, and fire extinguishing equipment. Reference
guide. A.N. Baratov and A.Ya. Korolchenko, editors. Khimiya, Moscow, Russia. 1990;
4. Information card of a potentially hazardous chemical or a biological substance. Poly
(iminocarbonimidoilimino-1,6-hexandiil) hydrochloride. State registration certificate, series ВТ (lat.
VT) №002189, Russian Register of Hazardous Chemical and Biological Substances, Moscow, 2002.;
5. Russian State Standard GOST 12.1.044-89 Fire and explosion safety of substances and materials.
Nomenclature of characteristics and methods for their detection.;
6. Accident prevention rules and emergency management in railway transporting of hazardous cargo.
Railway Transport Ministry of Russian Federation, Moscow, Russia, 1997.;
7. Occupational safety in chemical industry. G.V. Makarov, editor. Khimiya, Moscow, Russia, 1989.;
8. Russian State Standard GOST 12.4.021-75. Ventilation systems. General requirements.;
9. Russian State Standard GOST 12.1.005-88. General sanitary and hygienic requirements to the air of
workspace area.;
10. Russian State Standard GOST 12.1.004-91. Fire safety. General requirements.;
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 1
Safety Data Sheet registration number №
Valid until
page. 19
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11. Russian State Standard GOST 12.0.004-90. Organization of training for accident prevention for
personnel. General requirements.;
12. Russian State Standard GOST 9980.3-86. Paint materials. Packaging.;
13. Russian State Standard GOST 12.4.103-83. Special protective clothes, personal protection equipment
for hands and feet. Classification.;
14. Russian State Standard GOST R 12.4.013-97. Protective goggles. General technical specifications.;
15. Russian State Standard GOST 12.4.034-2001. Personal equipment for protection of respiratory
system. Classification and marking.;
16. Russian State Standard GOST 17.2.3.02-78. Environment protection. Atmosphere. Rules for
determination of maximum allowable emissions of hazardous substances by industrial facilities.;
17. СанПиН (lat. SanPiN) (sanitary regulations and standards) 2.1.7.1322-03. Hygienic requirements to
placing and disposal of industrial wastes and consumption residues. Approved by the Decree №80 by
Onischenko G.G., the Principal state sanitary doctor of Russian Federation, dated 30 April 2003.;
18. Russian State Standard GOST 19443-88. Dangerous freight. Classification and marking.;
19. Russian State Standard GOST 123009-76. Loading and unloading operations. General safety
requirements.;
20. Russian State Standard GOST 14192-96. Cargo marking.;
21. Reference catalogue. Personal protection equipment for industrial workers at oil-refining, chemical
and petrochemical facilities. Moscow, 1983.;
22. Safe Reference Levels of Impact (SRLI) for pollutants in ambient air for populated territories.
Appendix №3 to the Hygienic norms, State number 2.1.6.1339-03. Approved on 10 July 2006 by
Onischenko G.G., the Principal state sanitary doctor of Russian Federation.;
23. Maximum Allowable Concentrations (MAC) of hazardous substances in the air of the working area.
Appendix № 1 to the Hygienic norms, State number 2.2.5.1313-03. Approved on 21 December 2003
by G.G. Onischenko, the Principal state sanitary doctor of Russian Federation. State
number 2.2.5.1827-03.;
24. Maximum Allowable Concentrations (MAC) of hazardous substances in water sources for drinking,
household, and recreational use. Hygienic norms State number 2.1.5.1315-03. Approved by the
Decree №79 of the Principal state sanitary doctor of Russian Federation on 30 April 2003, № 79.;
25. List of norms for the fishing industry: maximum Allowable Concentrations (MAC) and Safe
Reference Levels of Impact (SRLI) of hazardous substances in water of natural fish breeding
reservoirs. Russian Federation State Committee for Fishing Industry. Approved on 28 April 1999,
№96. Russian Federal Research Institute of Fisheries and Oceanography (VNIRO), Moscow 1999.;
26. Hygienic norm substantiation for the two substances: polyhexamethylene guanidine hydrochloride
(«Biopag») and polyhexamethylene guanidine phosphate («Phosphopag») in the air of the workspace
area. Scientific report of the Disinfectology Institute of the Public Health ministry of Russian
Federation. Moscow, 2001. Page 20.;
27. State Registration Certificate for the disinfecting substance (active agent) «BIOPAG» №
RU.77.99.01.002.Е.002182.10.10 dated 26 October 2010.;
28. Report prepared by the FGU VNIIPO of EMERCOM of Russia «Parameters of fire risk of the
disinfecting substance BIOPAG», – Moscow, 2006 (RPO IETP is the document holder).;
29. Report prepared by the Russian Federal Research Institute of Fisheries and Oceanography (VNIRO)
«Ecological fishery estimation of the preparation «Biopag» for sweet water», – Moscow, 2006.;
30. Letter to FGU VNIIPO of EMERCOM of Russia from RPO IETP. About results of the research work
concerning combustibility of Biopag and Biopag-D in a solid form.;
page 20
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Safety Data Sheet registration number №
Valid until
Disinfecting substance «Biopag»
TU 9392-008-41547288-00 with changes № 11
31. «Maximum Allowable Concentrations (MAC) of chemical substances». Reference book. Yu.A.
Krotov, A.O. Karelin, A.O. Lait.;
32. Report on toxicity and a hazard effect of the active agent of «Biopag» (IETP, Russia). The Research
Disinfectology Institute, 2000.;
33. Scientific report prepared by FGUE Research Disinfectology Institute of Rospotrebnadzor of the
Russian Federation based on the results of investigation of polyhexamethyleneguanidine
hydrochloride, substance (BIOPAG) and disinfecting substance ("BIOPAG-D") on its basis, 2010.;
34. Russian State Standard GOST 31340-2007. Warning marking for chemicals. General requirements.;
35. Russian State Standard GOST 30333-2007. Safety certificate (MSDS) for chemicals. General
requirements.;
36. Carbonic oxide. Russian book of reference for work safety: In 3 books. — Second edition., revised
and enlarged. — Moscow, Publishing house of the Novation Center ENAS, 2007.;
37. Instruction №5/2005 on application of disinfecting substance (active agent) «Biopag».;
38. Technical specification TU 9392-020-41547288-02 «Disinfecting substance «Biopag-D».;
39. Technical specification TU 9392-009-41547288-2000 «Antimicrobial preparation «Biopag».;
40. Hazardous substances in industry. Reference book for chemists, engineers and doctors. Seventh
edition, revised and enlarged. In 3 books. 1977.;
41. Russian State Standard GOST 20010-93. Technical rubber gloves. Technical specifications.;
42. Russian State Standard GOST 10354. Polyethylene film. Technical conditions.;
43. Russian State Standard GOST 19433. Dangerous cargo. Classification and labelling.;
44. State Registration Certificate of a disinfecting substance «BIOPAG-D» dated 05.10.2010 №
RU.77.99.01.002.E.001633.10.10.;
45. State Registration Certificate of a disinfectant «Antimicrobial preparation «BIOPAG» №
RU77.99.88.002.E.007468.03.11 dated 25.03.2011.