cases of poisoning reported by physicians -...

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Cases of PoisoningReported by Physicians

Cases of Poisoning Reported by Physicians in 2004Published by: BfR Press and Public Relations OfficeEditors: Poison and Product Documentation Centre at the BfRNo of copies printed: 1000Typesetting and printing: Werbedruck Schreckhase, www.schreckhase.dePrinted on chlorine-free paper

ISBN 3-938163-08-9ISSN 1435-4047

Cases of Poisoning Reported by Physicians

Cases of Poisoning Reported by Physicians2004

Poison and Product Documentation Centre at the Federal Institute for Risk Assessment 11th Report (2004)

A. Hahn, H. Michalak, K. Begemann, K. Preußner, A. Engler


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Table of Contents

1 Introduction 51.1 Legal basis and activities of the Centre 51.2 Processing of reports received 51.3 Product data bank (poison information data bank) 71.3.1 Figures 71.3.2 Collaboration between the BfR, industry and reporting Poison Control Centres 7

2 Case reports by physicians 92.1 Evaluation of reports 92.2 Reports on cases of poisoning in 2004 92.2.1 Origin 92.2.2 Spectrum of cases reported 92.2.3 Causes of poisoning 102.2.4 Age structure and sex distribution 112.2.5 Degree of severity of health impairment 112.2.6 Outcome of illnesses 122.3 The product information system, PRINS 132.3.1 Rapid communications 142.3.2 Summary reports 15

3 Selected toxicological problems 183.1 Risk of aspiration carried by petroleum distillates and paraffins 183.1.1 Reports in the ESPED study, state as of 31 December 2004 183.1.2 Measures to be taken 183.1.3 Overall evaluations of liquids involving aspiration risks 193.2 Health impairments caused by toner 203.3 Case reports 223.3.1 Cases of poisoning by paraffins 223.3.1.1 Liquid products for grill lighting 223.3.1.2 Garden torch 233.3.1.3 Oil lamp 233.3.2 Food supplements 253.3.2.1 Maca powder 253.3.2.2 Atractylosides 273.3.2.3 Ephedra alkaloids 293.3.3 Foods 303.3.3.1 Butterfish/Escolar 303.3.3.2 Shiitake mushroom 313.3.4 Welding fumes 333.3.5 Internal combustion engines 34

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3.3.6 Sewage collector tank 353.3.7 Battery acid 383.3.8 Glow sticks 403.3.9 Multiple chemicals 413.3.10 Henna tattoos 433.3.11 Plants – Colchicum autumnale 443.3.12 Animals – Vipera berus 46

4 Annex 494.1 Overview of reported cases of poisoning in the period of

1 January–31 December 2004 494.2 Notification form 544.3 List of Poison Control Centres 554.4 Press releases on toxicological problems issued by the BfR in 2004 57


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1 Introduction

1.1 Legal basis and activities of the CentreWith the Chemicals Act (ChemG), legislation inthe Federal Republic of Germany laid the foun-dation "to protect humans and the environmentfrom harmful effects of dangerous substancesand preparations, particularly to make them rec-ognizable, to avert and to prevent the develop-ment of such effects" (according to §1).

For a realistic assessment of risks for humanhealth, importance has been increasingly as-cribed to the knowledge of data on human toxi-cology that can be obtained from the evaluationof cases of poisoning in humans. This is whylegislation has introduced compulsory notifica-tion of poisonings by attending physicians from1 August 1990, by the first amendment to theChemG (§16e).

A physician who is consulted for treatment orevaluation of sequelae of diseases caused bychemical substances or products is obliged tosubmit essential data on poisonings to the Poi-son and Product Documentation Centre at theFederal Institute for Risk Assessment (BfR).

According to the Chemicals Act, illnesses orsuspected poisonings associated with the fol-lowing substances are notifiable:� Chemical substances and products used in

the household, e.g. detergents and cleansingagents, hobby and DIY articles;

� Cosmetics;� Pest control products;� Plant protection products;� Wood preservatives;� Chemicals used at the workplace;� Harmful chemical substances in the environ-

ment and� Plants/animals.

Within the meaning of the Chemicals Act, theterm of poisoning designates all cases in which

health impairment has occurred, as well as sus-pected cases of poisoning. Under the Act, alsothe Poison Information and Treatment Centres(Poison Control Centres, PCC) were subjectedto compulsory reporting of their knowledge (ofgeneral importance) gained in the context oftheir activities.

1.2 Processing of reports receivedReports received on health impairment associ-ated with chemicals are subjected to an assess-ment procedure resulting in the rating of a pos-sible causal relationship between the toxicantand the manifestations observed, as well as oth-er conclusions. Such relationship may be classi-fied as "possible", "probable", "confirmed","none" or "cannot be assessed". The rules ap-plied in the assessment of individual caseshave been described in detail in the previousannual reports.

Differentiated analyses and evaluation of thedata on cases form the basis for the estimationof toxic risks in humans. For these purposes,the data on cases in humans are continuouslydocumented as case data sets and case re-ports. Information on identified risks is passedon to ministries, manufacturers and industrialassociations in the form of rapid communica-tions or annual summarizing reports by meansof the product information system PRINS (seeChapter 2.3). At the same time, the responsiblemanufacturers or distributors are requested tosubmit information on the measures envisagedby them to improve product safety.

The BfR publishes annual reports on the knowl-edge gained from the cases of poisoning re-ported by physicians. These publications areavailable on request in writing at the Presses-telle of the Federal Institute for Risk Assess-ment, Thielallee 88-92, D-14195 Berlin, Ger-many. In part, they have also been published as

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electronic documents on the internet(ww.bfr.bund.de).

A graphical representation of these tasks andprocedures is shown in Fig. 1.


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Notificationsphysicians§ 16e para 2

Human data

InformationPoison Control Centres

§ 16e para 3

Casedata bank

Productdata bank

Assessment of individual case

AnalysisRisk identification

aimed at scientific

information

Statistical analysesCase reportsPress release

Rapid communications

to manufacturers/distributorsministeries

industrial association

Criteriumsevere

health impairments

Summarizing reports

annually to manufacturers/distributors

Criteriumnon-severe

health impairments

Measures for risk minimization

Risk communication

aimed atrisk management

Notificationsindustrie

§ 16e para 1Dangerous

products/biocides

Cosmetics Regulations § 5dCosmetics

Voluntary notifications

Fig. 1: Terms of reference of the Poison and Product Documentation Centre

1.3 Product data bank (poison informationdata bank)

1.3.1 FiguresAt he end of 2004, 185 487 documents on indi-vidual products had been recorded in the poi-son information data bank maintained by theBfR, which can be accessed by the Poison Con-trol Centres in Germany thus supporting theiractivities in providing consultation and treatmentin cases of poisoning. The structure of the databank and the different types of product datasets have been described in detail in previousreports. The number of reports on products re-ceived by the Centre for Recording of Poison-ings at the BfR increased by 23 458 documentsin 2004 (Fig. 2).

1.3.2 Collaboration between the BfR, indus-try and reporting Poison Control CentresMore than 90 % of product data on cosmeticsreceived by the BfR are submitted by manufac-turers and distributors in electronic form, whilethe major part of reports made on a voluntarybasis, reports on dangerous preparations andbiocidal products is still submitted on paperforms.

Until the end of the year, 1 699 product formula-tions were received by the BfR through the elec-tronic information procedure (EMIL) elaboratedin cooperation with the Poison Control Centresand the German Cosmetics, Toiletries, Per-fumes, and Detergents Association (Industrie-verband Körperpflege und Waschmittel e.V. –

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Fig. 2: Notifications on products received since 1997 and transmission of information to the German Poison Control Centres

32,297

11,2200

20000

40000

60000

80000

100000

120000

140000

160000

180000

200000

1996 1997 1998 1999 2000 2001 2002 2003 2004

Notifications

185,487

141,970

Cosmetics

Products, voluntary

Products, legal (§16e)+biocides

Total


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Fig. 3: Notifications under §16e para 1 of the Chemicals Act: legal products and biocidal products

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

1997 1998 1999 2000 2001 2002 2003 2004

Dangerous preparations6,316

Biocides4,904

Notifications

Pro

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ct n

oti

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tio

ns

IKW), which is guided by the notification proce-dure for cosmetics. The data were transmittedby diskette and e-mail. The envisaged end pointof electronic data transmission is online datarecording and data transmission in the frame-work of a central poison information data bank.

Of the dangerous preparations and biocidalproducts notifiable under §16e para 1 of theChemicals Act, 11 220 data sets have been dis-tributed by transmission to the Poison ControlCentres so far (Fig. 3).

In the period between 1 August 1990, i.e. thebeginning of the compulsory notification, and31 December 2004, altogether 39 071 reportson cases of poisoning or suspected cases ofpoisoning were received by the BfR. In 2004,the reporting year considered, 5 541 notifica-tions were received (Fig. 4).

The increased number of notifications receivedin 2000 was due to an agreement with theBerufsgenossenschaften (BG, professional in-surance bodies in Germany responsible for oc-cupational safety, health protection and acci-dent insurance). According to this agreement,all notifications on cases of acute health impair-ment after contact with chemicals or chemicalproducts are directly reported to the BfR by theBerufsgenossenschaften.

2.1 Evaluation of reports

2.2 Reports on cases of poisoning in 2004

2.2.1 OriginIn 2004, 5 155 cases, i.e. 93 % of all cases noti-fied, were reported by the Berufsgenossen-schaften. The remaining 386 notifications (7 %)were essentially submitted by hospitals andmedical practitioners. Single notifications werealso received from pharmacies, poison controlcentres, the Arzneimittelkommission derDeutschen Ärzteschaft (Drug Commission ofthe German Medical Profession) or theArzneimittelkommission der DeutschenApotheker (Drug Commission of the GermanPharmacists), among others.

2.2.2 Spectrum of cases reportedFig. 5 provides a synoptic view of the spectrumof product groups involved in the cases report-ed. In 2004, as before, poisonings by chemical

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2 Case reports by physicians

Fig. 4: Cases reported (BG notifications 100 % = 5 155; non-BG notifications 100 % = 386)

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

90 91 92 93 94 95 96 97 98 99 00 01 02 03 04

Non-BG-notifications BG-notifications Year

Number

products and primary substances have re-mained in top position among the total of casesreported by the Berufsgenossenschaften. Allother product groups play a minor role withshares of less than 2 % each.

As expected, the spectrum of substances andproducts involved in poisonings is somewhatdifferent in the reports received from hospitalsand those received from medical practitioners.Also among these, notifications related to chem-ical products ranked first in the reporting year.They are followed, at a clear distance, by theprimary substances that are likewise subject tocompulsory notification. Next in the ranking are

health complaints caused by foods, beveragesand medicinal products that were reported al-though these are not subject to compulsory no-tification.

For a detailed list of toxicants in tabular formsee Annex. In this table, the cases reported in2004 have been classified by product applica-tion groups (assignment of toxicants accordingto their intended use).

2.2.3 Causes of poisoningThe Berufsgenossenschaften almost exclusivelyreported cases of exposure to poisons in thecontext of occupational accidents (ca. 96 % of


10

0

10

20

30

40

50

60%

BG notifications Non-BG notifications

Chem

. Pro

duct

s

Prim

ary

subs

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es

Food

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vera

ges

Med

icin

al p

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Indu

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Othe

rs*

* Others: Cosmetics/personal hygiene products,pesticides, agrochemicals, plants, fungi, ani-mals, veterinary medicines, weapons, others

BG notifi cations(100 % = 5 155 notifi cations)

Non-BG notifi cations(100 % = 386 notifi cations)

Chemical products 55.7 % (2 872 cases) 40.7 % (157 cases)

Primary substances 37.6 % (1 936 cases) 12.7 % (49 cases)

Foods and beverages 0.7 % (36 cases) 13.2 % (51 cases)

Medicinal products 1.6 % (22 cases) 12.2 % (47 cases)

Industrial accidents 0.4 % (20 cases) 10.4 % (40 cases)Others 5.4 % (285 cases) 14.5 % (56 cases)

Table 1: Spectrum of notifications (repeat listing of cases possible)

Fig. 5: Spectrum of cases reported (BG notifications 100 % = 5 155;non-BG notifications 100 % = 386)

cases). The remaining 4 % of cases referred toaccidents that occurred during the common useof a product or the cause of the accident wasunknown.

Also among the reports submitted by hospitalsand medical practitioners, accidents were thepredominant cause of poisoning (58 %) fol-lowed by exposure during common use (25 %).Suicidal action was reported in no more than1.8 % of cases. In the remaining cases, thecause has been unknown.

On principle, acute poisoning takes a dominat-ing position among the reports (Table 2). This isdue to the fact that the agreement on the trans-mission of reports on cases of poisoning by theBerufsgenossenschaften expressly provides forthe submission of reports on acute cases ofpoisoning only.

2.2.4 Age structure and sex distributionIn 2004, the share of poisonings in adultsamong the total of cases reported was 96.8 %.

The cases submitted by the Berufsgenossen-schaften were exclusively those involving adults.The share of cases in adults predominated alsoamong the reports received from hospitals andmedical practitioners while the share of childreninvolved was 43 % (Table 3).

2.2.5 Degree of severity of health impairmentAlso in 2004, the majority of cases reported re-ferred to minor health impairment only, bothamong the cases reported by the Berufs-genossenschaften and among those reportedby hospitals and medical practitioners. Moder-ate and severe health impairment is more oftenreported by medical practitioners or physiciansworking in hospitals because they also receivereports on suicide attempts (Table 5).

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Table 2: Duration of exposure



Acute 99.9 % (5 149 cases) 83.2 % (321 cases)

Chronic 0.1 % (4 cases) 15.8 % (61 cases)Unknown 0 % (2 cases) 1 % (4 cases)



Children 0 % (0 cases) 43.1 % (166 cases)

Adults 100 % (5 154 cases) 55.4 % (214 cases)Unknown 0 % (1 case) 1.5 % (6 cases)



Male 62.3 % (3 211 cases) 44 % (170 cases)

Female 22.0 % (1 134 cases) 44.3 % (171 cases)Unknown 15.7 % (810 cases) 11.7 % (45 cases)

Table 3: Age groups

Table 4: Sex distribution

The product groups involved most frequentlywith regard to the degree of severity of healtheffects have been listed in Table 6 for the casesreported by the Berufsgenossenschaften and inTable 7, for the cases reported by hospitals andmedical practitioners (45 cases). Of course, thetoxicants reported from occupational environ-ments were different from those reported fromthe private sphere because, for example, theavailability of certain product groups is a differ-ent one.

One of the reasons for the high number of cas-es involving lamp oil may be seen in the specificascertainment of such cases in collaboration

with ESPED (Erhebungseinheit für seltene pädi-atrische Erkrankungen in Deutschland – clinicalregistration unit for rare paediatric diseases inGermany) cooperating with almost all paediatrichospitals in Germany.

2.2.6 Outcome of illnesses For the notifications submitted by the Beruf-sgenossenschaften, the outcome is unknown inca. 85 % of cases. The reason is that in the ma-jority of cases, the report submitted is that bythe so-called "Durchgangsarzt" ("transition doc-tor" appointed by the Berufsgenossenschaft).The report form is completed after the patient'sfirst presentation. Therefore, such report does


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Health impairmentProduct groups Minor Moderate Severe

Primary substances 1 727 160 1

Cleansing products 814 58

Industrial cleansers 58 6

All-purpose cleansers 55

Oven and grill cleansers

34 2

Disinfectants/sterilizers 377 8

Paints and related materials 236 11 1

Paint thinners 107 5

Building materials 132 25

Glues 110 3

Sewage 2 3Galvanic cells 101 5 1

Table 6: Product groups involved most frequently, by degree of severity of health impairment (BG notifications 100 % = 5155 notifications)

Table 5: Degree of severity of health disturbances



None 1.4 % (70 cases) 13.5 % (52 cases)

Minor 90.5 % (4 669 cases) 60.4 % (233 cases)

Moderate 6.5 % (334 cases) 17.6 % (68 cases)

Severe 0.1 % (6 cases) 3.6 % (14 cases)

Cannot be assessed 1.5 % (76 cases) 4.9 % (19 cases)

not contain any information on the course of thepatient’s illness. In selected cases, enquirieswere made to obtain information on the courseof the disease. In the majority of cases onwhich information was available, patients hadrecovered completely.

Of the notifications submitted by hospitals andmedical practitioners, patients recovered com-pletely in 254 cases (67 %). In 118 cases (31 %), the outcome was unknown; in nine cas-es (2 %), late damage could not be excluded orpartial recovery was reported.

Altogether seven deaths were reported in 2004,two of these by the Berufsgenossenschaftenand five, by hospitals and medical practitioners.

The fatal two cases reported from workplaceswere poisonings by gases such as hydrogensulfide from an industrial sewage collection tank(cf. Chapter 3.3.6).

In the preceding year, regrettably also twodeaths were reported that referred to childrenwho had accidentally ingested paraffin-contain-ing colourless lamp oil (cf. Chapter 3.3.1).

In addition, two deaths were reported that hadbeen due to consumption of leaves of

colchicum being mistaken for those of bear'sgarlic (cf. Chapter 3.3.11) and one suicide in-volving the pesticide, parathion.

2.3 The product information system, PRINSThe notifications by physicians in cases of poi-soning legally required under the Chemicals Act(§16e para 2) are regularly evaluated to protectconsumers from health risks posed by chemi-cals and chemical products. Since 1994, the re-porting physicians, the responsible ministriesand the scientific community have been in-formed by annual reports on analyses of thesenotifications and the corresponding results. Inthe context of these notifications, the term, poi-soning is used to designate any health impair-ment associated with chemicals, including forexample also allergies.

Since 1998, manufacturers and distributors ofchemical products such as household chemi-cals, hobby articles, cosmetics, plant protectionand pest control products and correspondingproducts for commercial use have been in-formed about reports received by the BfR oncases of health impairment associated withtheir products.

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Table 7: Product groups involved most frequently, by degree of severity of health impairment (Non-BG notifications 100 %= 386 notifications)

Health impairmentProduct groups Minor Moderate Severe

Industrial accidents 40

Foods and beverages 34 8 4

Food supplements 25 4 3

Lamp oil 24 24 3

Primary substances 31 15 2

Cleansing products 14 2

Cosmetic creams/ lotion 10 1Fire lighting products 1 5 2

2.3.1 Rapid communicationsIf reports on severe health risks (except thoserelated to suicide attempts) are received by theBfR, it will provide for immediate information ofthe manufacturer/distributor of the chemicalproduct involved as well as the competent in-dustrial association/federal trade associationand the responsible ministries, the Federal Min-istry of Consumer Protection, Food and Agricul-ture, the Federal Ministry for the Environment,Nature Conservation and Nuclear Safety, andthe Federal Ministry of Health and Social Secu-rity as well as the Federal Office for ConsumerProtection and Food Safety.

Between 1 January 1998 and 31 December2004, altogether 21 rapid communications wereprepared and communicated. A synoptic viewof these is given in Table 8. For explanationswith regard to individual cases until 2003, refer-ence is made to the 2002 and 2003 Annual Re-ports. In the reporting year of 2004, two rapidcommunications were distributed. The casesconcerned were two fatal ones in children asso-ciated with the ingestion of colourless paraffinsfrom a garden torch and an oil lamp. The casereports are described in detail in Chapters3.3.1.2. and 3.3.1.3.


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Year Product Toxicologically relevant substance

Person exposed

Outcome Proposal by BfR (P) and results (R)

1998 Impregnating agent

Fluorinated hydrocarbons

Adult Death P: Warnings for asthmaticsR: Accepted

1998 Disinfectant Quaternary ammonium compounds (surfactants)

Elderly adult Death P: Information, labelling „corrosive“R: Accepted

1999 Toilet drain cleanser

Sodium hydroxide Adult Caustic burns None

1999 Solvent Petrol Adult Pulmonary oedema

None

1999 Depilatory cream Thioglycolic acid Adult Scars None

1999 Disinfectant Quaternary ammonium compounds (surfactants)

Elderly adult Death P: Information, labelling

1999 Industrial cleanser

Sodium hydroxide Young child Caustic burns P: Information

1999 Medicinal product Dimenhydrinate Infant Death P: Warnings

2000 Cream bath product

Surfactants Elderly adult Death P: Information

2000 Lamp oil Paraffi ns Young child Severe pneumonia

P: Partial banR: Accepted, paraffi n substitute

2001 Disinfectant Alkylamine (surfactant)

Elderly adult Death P: Information

2.3.2 Summary reportsNotifications referring to non-severe health im-pairment caused by chemical products in occu-pational or private environments are transmittedto the manufacturers/distributors in the firstquarter of each new year in a summarized form.As requested by manufacturers, alsosuicides/suicide attempts have been included inthe summary notifications since 2003 irrespec-tive of the degree of severity of poisoning.Thus, manufacturers and distributors gainknowledge on possible risks involved in the han-dling of their products, which enables them toexercise responsible care with regard to theirproducts. If they find the information provided tobe insufficient, additional information can beobtained from the BfR. Much use has beenmade of this opportunity. The information pro-

vided for the manufacturer is a contribution toincrease product safety and thus, to improveconsumer protection. There has been great in-terest in such information. For example, acci-dent analyses have revealed that eye injuriescaused by chemical products have frequentlyoccurred in spite of wearing safety goggles.The safety data sheet should therefore point out"closely fitting safety goggles".

Summary reports for the year 2004 referred to303 products and were formally transmitted to148 manufacturers. The table below (Table 9)provides a synoptic view of product applicationgroups (minimum three listings) of the 2004summary reports. Strikingly high numbers havebeen recorded for cleansing products (90) anddisinfectants (61).

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Table 8: Rapid communications 1 January 1998 – 31 December 2004

Year Product Toxicologically relevant substance

Person exposed

Outcome Proposal by BfR (P) and results (R)

2001 Tea (biodrug) Atropa belladonna Adolescent Respiratory insuffi ciency

P: Information

2002 Lavatory cleaner Surfactant Elderly adult Caustic burns P: Information

2002 Mild detergent Surfactant Elderly adult Death P: Information

2003 Cleansing product

Surfactant Elderly adult Respiratory insuffi ciency

P: Information

2003 Food supplement Proteins Adult Severe allergy P: Information

2003 Fumigant Sulfuryl difl uoride Adult Death P: Information

2003 Drain cleanser Potassium hydroxide solution

Child Severe caustic burns

P: Information

2003 Disinfectant Peracetic acid Adult Respiratory insuffi ciency

P: Information

2004 Garden torch Paraffi ns, colourless

Infant Respiratory insuffi ciency, death

P: Information, additional EU ban on colourless / unscented paraffi nsR: Accepted

2004

Oil lamp Paraffi ns, colourless

Infant Respiratory insuffi ciency, death

P: Information, additional EU ban on colourless/unscented paraffi nsR: Accepted


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First level Second level Third levelAgrochemicals 7

Chemical products 254 Building materials, auxiliary products

4

Building materials 6

Fuels, liquid 14 Lamp oil 14

Offi ce materials, chemical

13

Disinfectants/sterilizers 61

Glass-working, auxiliary products

3

Glues 3

Metallurgy, auxiliary products

3

Cleansing products 90 Descaling products 3

Dishwasher detergents

4

Dishwasher cleansers 3

Industrial cleansers 9

Milking machine cleansers

11

Lavatory cleansers 13

Detergents, auxiliary products

4

Water treatment products

3

Cosmetics/personal hygiene products

18 Skin care products 15 Creams 10

Pesticides 24 Fungicides 4

Herbicides 7Insecticides 9

Table 9: Product groups in 2004 summary reports

Table 10 shows the number of moderate healthdisturbances associated with the productgroups in 2004. The remaining product groupswere involved in minor health impairment.The BfR also performs cumulative data analyses

of case reports. If trends become apparent, themanufacturers of the products confirmed are in-formed. In turn, manufacturers are requested bythe BfR to communicate comparable data andtrends that may serve to improve product safety.

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First level Second level Third levelAgrochemicals 1

Chemical products 36 Paints and related materials

1

Building materials 1

Fuels, liquid 7 Lamp oil 7

Offi ce materials, chemical

4

Disinfectants/sterilizers 3

Galvanizing agents, auxiliary products

2

Glass-working, auxiliary products

1

Coolants 1

Metallurgy, auxiliary products

2

Cleaning products 10 Floor polishes 1

Industrial cleaners 1

Milking machine cleaners

2

Furniture polishers 1

Cosmetics/personal hygiene products

2 Hair care products 1 Dyes/colorants 1

Skin care products 1 Creams 1Pesticides 2 Insecticides 2 Phosphoric esters 1

Table 10: Product groups associated with moderate health disturbances of summary reports in 2004

3.1 Risk of aspiration carried by petroleumdistillates and paraffinsAs repeatedly reported earlier, liquid fuels con-taining paraffins and petroleum distillates thatare used in ornamental oil lamps, garden torch-es, for grill lighting and fire-breathing, carry ahigh potential risk. Very low quantities, often on-ly a little sip, may result in severe chemicalpneumonia. In Germany, already five deaths ininfants and young children have been recordedsince 1990. In the reporting year of 2004, twoinfants died of the consequences of aspirationof colourless paraffin-containing lamp oils (seealso case reports).

In addition to the regular documentation of cas-es under §16e of the Chemicals Act , the BfRhas recorded cases of poisoning involving lampoils in collaboration with the clinical registrationunit for rare paediatric diseases in Germany(ESPED) and almost all German paediatric hos-pitals since 1 March 2000. A detailed report onthe first part of the study (ESPED I: 1 March2000–28 February 2003) was published in theannual report "Cases of Poisoning Reported byPhysicians in 2003". Since lamp oil substitutes(rape seed methyl ester, high-viscosity mineraloils and paraffins) are being placed on the mar-ket, the study will be continued until 31 Decem-ber 2006.

The ESPED study "Lamp oil poisoning in Ger-many" has proved to be a reliable instrument ofpostmarketing control. It has reliably describedthe introduction of substitute substances andthe residual risks posed by lamp oils for infantsand young children. The figures documented sofar demonstrate that the frequency of lamp oilaccidents requiring inpatient treatment has con-tinued to be on a decrease in Germany. The banon coloured and scented lamp oils containingparaffins or kerosene that was introduced inGermany on 1 January 1999, the placing on the

market of substitutes and the warning to con-sumers issued by the most different institutionsand the media appears to have taken effect. Acomparable trend has also been recorded bythe German Poison Control Centres. In 2004, asalready in the reporting period of 2003, no sin-gle case of health impairment due to the newsubstitutes was documented, neither at the BfRnor at the German Poison Control Centres.

3.1.1 Reports in the ESPED study, state as of31 December 2004Between 1 March 2000 and 31 December 2004,the BfR received 616 case reports from ESPEDwith a total number of 458 questionnaires beingreturned (67 %). 411 of these cases could bevalidated as lamp oil ingestion with a 40 % rateof pneumonia (in 165 infants and young chil-dren). In the majority of cases (61 %), pneumo-nia was caused by lamp oils containing paraf-fins or petroleum distillates that were either oldproducts (i.e. coloured or scented productssold before the ban) or uncoloured and un-scented products not subject to the ban sofar. Observations made by different partieshave indicated that the uncoloured and un-scented products containing paraffins/petrole-um distillates that are not subject to the ban aremore aggressively advertised and sold with in-creasing market shares by wholesalers and re-tailers. A possible reason is that these productsare a good fuel for garden torches and for light-ing of charcoal (products for grill lighting).

3.1.2 Measures to be takenAlarmed by the two tragic deaths in 2004 thatwere caused by products containing paraffinsand petroleum distillates (lamp oil in one caseand liquid fuel for garden torches in the other),the Federal Institute for Risk Assessment andthe Ministry for the Environment, Nature Conser-vation and Nuclear Safety have again (as al-ready in 1993/1996) demanded a ban on all


18

3 Selected toxicological problems

products of such type on the EU level. At pres-ent, a risk survey is performed by the EU in allits member states in order to achieve an appro-priate decision. Until such a decision isachieved, it is of utmost importance to keenlyprotect children and to draw attention to substi-tute fuels (e.g. on a rape oil basis). In October2002, an EU standard for the design of child-proof oil lamps took effect (EN 14059: Decora-tive oil lamps – Safety requirements and testmethods), which, however, has not yet been tak-en up by the German industry in spite of per-sisting accidents. Also the results of the ESPEDstudy have suggested that the passive protec-tion of children can be improved essentially, giv-en the fact that children have very frequently in-gested the toxicant from non-childproof oillamps. When grilling is performed in the pres-ence of children, paraffin-/kerosene-containingliquid products for grill lighting should not beused. The BfR has pointed out this special riskin press releases.

3.1.3 Overall evaluations of liquids involvingaspiration risksEvaluations of all notifications received by theBfR of cases associated with liquids involvingaspiration risks such as lamp oils, liquid prod-ucts for grill lighting and fire eating/breathing aswell as case reports of the ESPED study haveshown a decreasing tendency. In these evalua-tions, the essential share in the figures is repre-sented by the ESPED study data (ca. 85 %).The total number of cases recorded at the BfRhas distinctly decreased, while the share ofcases of aspiration pneumonia has shown aslight decrease. This tendency becomes evi-dent even if these figures refer to those casesonly where knowledge of the formulation of theproduct involved has suggested the ingestion ofparaffin-containing liquids (Fig. 6). Thus, the re-sults of the ESPED study and notifications un-der §16e have demonstrated the fact of a de-creasing total number of ingestion of liquids in-volving aspiration risks in Germany.

19

Fig. 6: Frequency of notifications under §16e Chemicals Act of cases involving paraffin-containing products from 1 Janu-ary 2000 – 31 December 2004 (linear trend, the figure for 2000 with regard to ESPED cases was obtained by linear ex-trapolation since the study started on 1 March 2000)

76

5763

38 3936

16 20

26

23

0

10

20

30

40

50

60

70

80

90

100

2000 2001 2002 2003 2004

All notifications (paraffin-containing products) of these pneumonia Year

Cases

The severe health impairments caused bycolourless lamp oils and liquid products for grilllighting and fire eating/breathing have shownthat the protection of the population, particularlyof infants and young children, has to be furtherimproved. Appropriate measures on an EU levelare expected to be initiated in 2005.

3.2 Health impairments caused by tonerSingle reports on health impairments caused bytoners were received from the field of occupa-tional medicine. They primarily referred to healthcomplaints involving the mucosal membranessuch as rhinitis, eye and throat irritation andasthma-like cough. One of these cases was de-scribed in the annual report "Cases of Poison-ing Reported by Physicians in 2002" by the Fed-eral Institute for Risk Assessment and informa-tion provided for physicians on the manifesta-tions and relationships observed.

Until the end of 2004, physicians and Berufs-genossenschaften reported to the BfR 48 casesinvolving toners (reporting year 2000: 1 case;2001: 5 cases; 2002: 11 cases; 2003: 5 cases;2004: 26 cases). 15 cases were reported byphysicians working in hospitals, nine by medicalpractitioners and two, by Poison Control Centres(three by others). 19 reports were received fromBerufsgenossenschaften. The persons involvedwere exclusively adults (24 females, 21 males,three cases unknown). Most of the exposures(46) occurred at the workplace, only two ofthem in the private sphere. In most cases, theexposure was chronic (26), but also acute cas-es occurred (20, in two cases unknown). Theroute of exposure occurring most frequentlywas inhalation (42), but also exposure throughthe skin (10) and the eyes (2) and one case ofingestion were reported (repeated listing possi-ble). The health impairments experienced bythe persons affected were predominantly classi-fied as "minor" (28). "Moderate" health impair-ments were observed in 15 cases, no impair-ment in three cases. In two cases, the health im-pairment could not be assessed on the basis of

the data available. The health impairments ob-served referred mainly to the respiratory tractincluding cough (20), rhinitis (16), bronchitis(13), but also dyspnoea (12) and bronchial asth-ma (9). Also eye irritation, headache and aller-gies (9) were reported.

The Interessengemeinschaft der Ton-ergeschädigten (ITG, a self-help group of per-sons affected by health damage due to toners)has stated the number of persons affected tobe at least 700. This was reported on a hearingof the ITG performed at the BfR on 1 September2004. Printing and copying processes are com-plex physical and chemical processes associat-ed with the liberation and emission into the in-door air of volatile organic compounds of differ-ent chemical groups, microparticles from tonersand papers and gases. As a result, users oflaser printers and copying machines are ex-posed to a higher or lower degree to a numberof substances, among these also substancesinvolving health hazards. For the evaluation ofpossible health damage caused by toners, theBfR has been collaborating with other federal in-stitutions, such as the Federal Institute for Occu-pational Safety and Health (BAuA/FIOSH), theFederal Institute for Materials Research andTesting (BAM) and the Federal EnvironmentalAgency (UBA) all of which have already dealtwith the problem in the context of scientifictasks and studies. A BfR pilot study on healthrisks posed by toners is envisaged.

The case report below demonstrates how diffi-cult an evaluation of symptoms associated withexposure to toner dusts may be.

Case reportHealth impairment after contact with tonerin a patient suffering from atopic diathesisA 42-year-old female patient had been suffer-ing from cough and sudden dyspnoea since1985. Having moved into a newly furnishedoffice in 1989, she began to suffer increas-


20

ingly from breathing difficulty at her work-place. The patient attributed her complaints tothe impact of dust emitted by copying ma-chines and printers. She was examined andher medical condition assessed, with a tenta-tive diagnosis of obstructive disease of therespiratory tract. There was no sufficient evi-dence to incriminate the patient's occupationas the cause of her breathing difficulties.

Manifestations/courseThe case history revealed certain indicationsof frequent respiratory tract complaints at theworkplace.

When packaging deep-frozen products in thespring of 1985, the patient experienced forthe first time cough and an oppressive feelingwhen breathing. These manifestations abatedin her private home. This was followed bymanifestations such as a runny nose, sneez-ing and irritation of the conjunctivae of theeyes. Later, she also developed manifesta-tions on her hands, particularly after exposureto dust emitted during reconstruction work inher office. Reportedly, she developed 'influen-za-like' complaints particularly when workingat copying machines or laser printers. Duringweekends and holidays, her condition im-proved clearly. Asthma-like complaints requir-ing increased administration of medicinesand allergic rhinoconjunctivitis were stated.However, examinations performed to deter-mine exposure at the workplace did not re-veal any clear evidence of an occupationalcause of the patient's bronchial asthma. Vari-ous occupational provocation tests were car-ried out on the basis of the patient's assump-tions about substances that might have trig-gered the complaints. After working at acopying machine, inhalation of dust broughtalong from her workplace as well as afterstaying in an archive of medical files, the pa-tient developed breathing difficulties compa-

rable to those experienced at her workplace.However, measuring techniques were unableto unequivocally detect any reaction of therespiratory tract in these provocation tests. Itwas assumed that the patient's complaintsmight have to be attributed to a sick buildingsyndrome. It was stated that no risk of atrend-setting deterioration of the disease wasseen as that could be associated with a con-tinuation of her previous occupation. The lastexpert opinion of 1996 concluded that thepatient was suffering from a rhinopathy due tohouse dust mites which had been partlycaused by exposure to such mites. In thiscontext, the exposure to house dust mites inthe patient's home was considered as less in-tensive than that at the workplace becausethe patient had taken measures to control theinfestation by house dust mites in her privatehome. However, no sufficient evidence wasfound that would have permitted to attributethe bronchial disease of the patient to anti-genic influences at the workplace or to the in-criminated action of dusts emitted by copyingmachines and printers. Great importance wasattributed to the patient's high cigarette con-sumption as a cause of the persistence ofher chronic bronchial asthma. Furthermore, asensitisation to cat epithelium was found toplay an additional role in the unspecific in-crease of responsiveness of the bronchialsystem.

NotesIn the case described, a subjective health im-pairment was experienced at the workplace bythe patient who had been suffering from an un-derlying allergic disease. Nevertheless, no evi-dence of a workplace-associated cause lead-ing to occupational disease was found by exam-inations performed with regard to dust exposureat the workplace.

21

3.3 Case reports

3.3.1 Cases of poisoning by paraffins

3.3.1.1 Liquid products for grill lighting

Respiratory insufficiency in a young childafter ingestion of a liquid product for grilllighting A two-year old boy drank and aspirated anunknown quantity of a liquid product for grilllighting. As a consequence, artificial respira-tion had to be performed. In the furthercourse, the patient developed subglotticgranulomas, in addition to pneumonia. Hewas referred to inpatient treatment, whichlasted for almost three weeks and resulted incomplete recovery.

Manifestations/courseAfter ingestion, the child showed signs of res-piratory insufficiency. Since primary oxygensupply was insufficient as a therapy, the boyhad to be intubated and respirated.On admission to hospital, the little patient wasanalgosedated and kept under mechanicalventilation applied equally on both sides ofthe chest. Auscultation revealed crepitationover the lung fields. Other organ findingswere normal. Pneumonia, which could alsobe verified radiologically, receded slowly sothat respiration could be withdrawn from day4 and extubation performed on day 6. In thefurther course, a marked inspiratory stridorwas found to be present. Bronchoscopy wastherefore performed on day 10, which re-vealed subglottic granulomas. The patient re-mained under intubation and artificial respira-tion. Three days later, bronchoscopy was re-peated under laser conditions at an ENT hos-pital. Except for a moderate mucosal swelling,other manifestations were not found to per-sist. After cortisone administration andsuprarenin inhalation, extubation could beperformed three hours later. Stridor was no

longer found to be present. A secondary in-fection with Haemophilus influenzae detectedin the tracheal secretion was treated with an-tibiotics. After 18 days, the patient had com-pletely recovered and was discharged.

NotesThe detailed composition of the liquid involvedwas not available. In most cases, the only rele-vant components contained in liquid productsfor grill lighting are hydrocarbons such aspetrol, paraffin oil, isoparaffins, kerosene and,less often, also isopropanol. Investigations intoeleven product formulations performed at theFederal Institute for Risk Assessment (BfR) re-vealed as ingredients: lamp oils in six, kerosenein three and petrol in two products. The twoproducts containing petrol, however, had beenavailable on the market only until 2001.

Ingestion of petrol or kerosene is mostly fol-lowed by the typical foetor ex ore since thesesubstances are largely excreted through therespiratory tract. In the case described above,such typical smell was not described, however,the authors of the report may just have failed todo so. The hydrocarbons concerned have chainlengths between C9 and C15 and involve a highrisk of aspiration because of their physico-chemical properties such as low viscosity, lowsurface tension and low vapour pressure. Theyreadily pass the epiglottis by creeping and thusmay cause severe chemical pneumonitis. Aspi-ration of amounts as low as < 1 mL may inducepneumonia in humans. The cardinal sign is aninitial and often persistent cough. In addition,vomiting may occur. This may be followed bydyspnoea and/or tachypnoea, cyanosis andless frequently, by somnolence. In cases of pul-monary manifestations, pneumonitis may devel-op in ca. 25-50 % of cases. However, also in theevent of an initial absence of manifestations,pneumonitis may develop in 10-20 % of cases.Death due to progressive pulmonary oedema is


22

also possible. Less often, pneumatoceles havebeen observed. In cases of ingestion of>1mL/kg b.w. or suspected aspiration it is al-ways recommended to seek medical advice in ahospital. In all patients suffering from initial man-ifestations, clinical and/or radiological examina-tions are required to exclude pneumonia. X-rayexamination should be performed two hours af-ter ingestion but not earlier. Clinically asympto-matic patients with pathological X-ray findingsshould undergo clinical observation for 6-12hours. The aspiration problem associated withlamp oils for use in ornamental lamps, liquid fu-els used by fire breathers and also liquids forgrill lighting has already been comprehensivelydealt with by the Federal Health Office (BGA),the Federal Institute for Health Protection ofConsumers and Veterinary Medicine (BgVV)and their successor institution, the Federal Insti-tute for Risk Assessment (BfR).

Evaluation of the case described:In the case described above, a causal relation-ship between the ingestion and the manifesta-tions observed has been rated as probable onthe basis of the information given on the tempo-ral relationship and in the absence of othercauses, for the severe health impairment suf-fered by the patient.

3.3.1.2 Garden torch

3.3.1.3 Oil lamp

Severe health impairment with lethal out-come in two infants after ingestion ofcolourless and unscented lamp oils con-taining paraffin In the context of notifications of cases of poi-soning under § 16e para 2 of the GermanChemicals Act, two severe cases of healthimpairment with a lethal outcome were report-ed to the Federal Institute for Risk Assess-ment (BfR). The notifications referred to a girlaged 13 months (date of accident 16 May

2004) and a boy aged one year and eightmonths. In both cases, the substances in-volved were colourless and odourless lampoils on a paraffin basis. Both children diedfrom the sequelae of lamp oil aspiration, inspite of intensive medical treatment.

Case No 1: Garden torchWhen playing in the garden, a girl aged 13months drank an unidentified quantity of clearand odourless lamp oil contained in a gardentorch. The manufacturer of the product hasremained unknown so far. According to analy-

23

Fig. 7: Garden torch

ses performed, the product involved consist-ed of paraffins (long-chain alkanes, fractionsC9 - C14) and was labelled with R 65 under theGerman Regulations on Dangerous Sub-stances and Materials (Gefahrstoffverord-nung – GefStoffV).

Manifestations/courseThe child was reported to have coughed,retched and vomited several times immedi-ately after ingestion. After an emergencyphysician had referred her to a hospital which

took place without delay, the little patient'scondition deteriorated dramatically, as seenby signs of respiratory insufficiency, increaseof heart rate and cyanosis. She was artificial-ly respirated and transferred to the paediatricintensive care unit of a large hospital. On ar-rival, a decompensated respiratory acidosiswith a pH of 7.2 was already found to bepresent. Chest X-ray revealed extended ac-cumulation of fluid in both lungs, with pleuraleffusion right in the sense of an extendedchemical pneumonia. In the further course,the clinical picture showed a pronouncedacute respiratory distress syndrome (ARDS)which developed shortly afterwards. In spiteof massive measures of intensive medicalcare, no oxygen saturation could be achievedeven at the highest ventilation pressure avail-able. After a sudden decrease of the heartrate followed by cardiac arrest, cardiac mas-sage, intratracheal administration of threedoses of adrenaline and defibrillation re-mained unsuccessful. The child died after ca.twelve hours from the sequelae of lamp oilaspiration, having developed a severe pneu-monia and destruction of lung tissue, whichwere confirmed histologically.

Evaluation of the case described:Based on the information received on thetemporal relationship between ingestion andmanifestations, a causal relationship is proba-ble.

Case No 2: Oil lampA boy aged 20 months drank an unknownamount of a colourless and unscented paraf-fin-containing oil from a lamp (a heavy glassbottle equipped with a metal ring that report-edly had held a wick). However, it has alsobeen considered as possible that the boy hadonly sucked from the wick because the latterwas found beside the bottle. The lamp hadbeen placed on the terrace. The manufactur-

er of the product was known. Also in thiscase, the substance involved consisted ofparaffins both according to the product labelsubmitted and the analyses performed.


24

Fig. 8: Oil lamp

Manifestations/courseThe child was reported to have coughed im-mediately and vomited later on. After admis-sion to the nearest hospital, the boy was intu-bated and respirated while developing an in-creasing clouding of consciousness. Due tocardiac arrest, cardiopulmonary resuscitation(by mechanical measures and medication)over a short period became necessary andas a result, temporary haemodynamic stabi-lization was achieved. When respiratory insuf-ficiency continued to deteriorate, the boy wastransferred by helicopter to a university hospi-tal. In spite of aggressive respiration and re-peated catecholamine administration, a respi-ratory and haemodynamic stabilization couldnot be achieved again when the patient de-veloped right ventricular failure. A thoracicECCPAD implantation was performed (extra-corporeal membrane oxygenation). In the fur-ther course, the patient became anuretic. Un-der conditions of a considerable generalizedmetabolic disturbance, the patient developed

progressive hyperkalaemia and haemolysis. Areduction of potassium levels could beachieved by haemodialysis that had to beperformed because of renal failure unrespon-sive to therapy. Episodes of rising tempera-ture remained largely refractory to therapy.In spite of massive measures of intensivemedical treatment including aggressive respi-ration and extracorporeal membrane oxy-genation, the patient died after three daysfrom the sequelae of lamp oil aspirationwhich included development of multiple or-gan failure and brain damage.

NotesDue to the particular hazard involved in lampoils, the former Federal Institute for Health Pro-tection of Consumers and Veterinary Medicine(BgVV) had demanded a ban on the marketingof lamp oils. In Germany, a ban on the market-ing of coloured and scented lamp oils contain-ing paraffin and kerosene was achieved in1999. Since mid-2000, this ban has been effec-tive on the European level. Obviously, this meas-ure has not been adequate to protect infantsand young children. The ban on marketingshould be extended as soon as possible to in-clude also colourless and unscented products.In a press release, the BfR has issued a warn-ing not to use such lamp oils in the household.

When including the two notifications describedabove, altogether five deaths of children attrib-utable to lamp oils containing paraffin andkerosene have been reported. Additionally, anumber of children have suffered severe healthdamage. As a conclusion, such products are tobe rated among those household chemicalswhich are most dangerous for children betweenone and three years of age. The potential haz-ard involved is to be attributed to the specialphysicochemical properties of these lamp oils.Ingestion of very low quantities of less than onegram may result in the oils 'creeping' into the

lungs and causing severe inflammation com-monly referred to as chemical pneumonia.

Since 1970, German poison control centres hadreceived ever-increasing numbers of inquiriesabout lamp oil poisoning. In 1994, between 250and 300 cases of chemical pneumonia in in-fants and young children were calculated tohave occurred per 1000 of such inquiries. A de-crease in the number of reported cases involv-ing severe health damage was recorded for thefirst time after a number of preventive measureshad been implemented by the predecessor in-stitute of the Federal Institute for Risk Assess-ment. Such measures included child-resistantclosures, warnings, labelling (risk phrase R 65,'harmful'), and a ban on the marketing of scent-ed and coloured lamp oils containing paraffinand kerosene for use by the private consumer(see Chapter 3.1).

3.3.2 Food supplements

3.3.2.1 Maca powder

Severe course in a case of eosinophilicvasculitisA 22-year-old patient was suffering from aneosinophilic vasculitis associated with adultrespiratory distress syndrome (ARDS) with asevere course. The cause of the diseasecould not be conclusively elucidated. The pa-tient had taken a muscle building productover 20 days that was taken into considera-tion as a triggering agent. However, no allergytests had been performed before the presentreport was recorded. The product containedMaca powder, vitamin E and zinc. The patienthad to be respirated for seven days. Inpatienttreatment lasted for 18 days.

Manifestations/courseThe patient was admitted to hospital due to aswelling of lymph nodes in his right inguinal

25

region lasting for ten days. In addition, hecomplained of exhaustion, night sweat andcough. In order to exclude a malignant under-lying disease, a lymph node puncture wasperformed under spinal anaesthesia. Duringthis procedure, the patient already developedconsiderable dyspnoea associated with re-duced gas exchange and a peripheral oxy-gen saturation of 84 % when breathing indoorair. At first, therapeutic attempts includednon-invasive artificial respiration. Due to a fur-ther deterioration of the patient's condition,he was transferred to the intensive care uniton the following day. There, the striking signsof tachypnoea with respiratory rates of up to30/min and a peripheral oxygen saturation of88 % were recorded under conditions of oxy-gen supply by nasal tube. Because of a fur-ther deterioration (peripheral saturation 75%), the patient was intubated and respirated.Still, the gas exchange was found to be ex-tremely reduced. Bronchoscopy was per-formed without delay and revealed only lowamounts of a yellow-brownish secretion with-out any obstruction of the airways. The mu-cosa was found to be normal except for red-dening and petechial haemorrhages. Theclinical picture found was that of a severeARDS associated with pronounced confluentshadowing over both lungs revealed by X-rayand shadows from pleural effusions revealedby computer tomography. Based on a tenta-tive diagnosis of an infectious-septic process,a broad-spectrum antibiotic therapy was initi-ated. Nevertheless, laboratory analysis re-vealed only a moderate increase of inflamma-tory parameters and a significant increase ofeosinophils in the differential blood count(23.5 %, reference value: 2.7 %). After a sep-tic process had been excluded, a tentative di-agnosis of an allergic-immunological causewas assumed and therefore, it was decidedto perform a probatory high-dose steroid ad-ministration. Already administration of the first

dose of 500 mg of prednisolone resulted in asignificant improvement of the patient's con-dition. Gas exchange parameters improvedcontinuously, pulmonary infiltrates receded,and eosinophil levels returned to normal. Dueto the clinical picture and the findings madeby lymph node biopsy associated with anecrotizing vasculitis and considerableeosinophilia, the tentative diagnosis statedwas that of an eosinophilic vasculitis of un-clear origin. After seven days, extubation ofthe patient could be performed without anyproblems as he exhibited sufficient sponta-neous respiration and a good vigilance. Inparallel to the ARDS, the patient had devel-oped a considerable coagulation disorder as-sociated with thrombopenia, hypofibrino-genaemia and increased D-dimer levels asan expression of hyperfibrinolysis. However,there was no increased haemophilia.

Neither external nor internal medical historyrevealed any event or responsible agent thatcould be considered as a trigger for the aller-gic-immunological process observed in thepatient. The muscle building product takenbefore the onset of the disease was taken in-to consideration as a possible cause. No sim-ilar cases have become known so far.

NotesThe muscle building product contained a rootpowder from the plant, Lepidium meyenii, alsoreferred to as Maca, which is imported from Pe-ru. In addition, the preparation contains vitaminE and zinc oxide. It is sold as a vitality-enhanc-ing food supplement for health-conscious peo-ple. According to the responsible food controlauthority, it is marketable as a food.

Although closely related to the popular gardencress (Lepidium sativum), the perennial Macaplant has been almost unknown in Europe sofar. Maca was cultivated as a crop plant in Peru


26

in pre-Columbian times already. The edible andnutrient-containing part of the plant is the tuberhaving a size of ca. 8 cm in diameter. The softouter layers are rich in sugars. The more solidinner tissues of the tuber accumulate mainlystarch, but also valuable proteins. The contentof nutrients is even higher than that of cerealsand potatoes. The Maca tuber contains ca. 60% of carbohydrates (mainly starch, but also var-ious types of sugar), 10-13 % proteins, 8-9 %dietary fibre and 2-3 % lipids, mainly fatty acidssuch as linoleic and oleic acid. In addition, itcontains important minerals such as iron and io-dine, but also calcium and magnesium. Othersubstances contained include alkaloids, tanninsand saponins whose biological activity in hu-mans still requires further research. Owing to itsoptimal ingredients, Maca became a medicinalplant surrounded by mysticism in the Andeanregion. It was used as a holy medicinal plant al-ready by the Incas. World-wide, Maca powderhas gained increasing popularity because it issaid to enhance physical energy, enduranceand stamina in athletes, etc.

Evaluation of the case described:In the absence of results of allergy tests, a pos-sible relationship cannot be assessed at present.

3.3.2.2 Atractylosides

Intrauterine hepatic damage of unclear ori-gin after exposure to atractylosidesA female infant aged one month and 20 dayswas admitted to hospital due to an increas-ingly poor general condition. The findingsmade included an inadequate circulation dueto vitamin-K deficiency associated withcholestasis under conditions of hepatopathy.An intrauterine hepatic damage due to theadministration of plant products allegedlycontaining atractylosides was suspected.One of the products involved had been takenby the mother during the last three months ofgestation and the second one, during the lac-

tation period. Both products had been mar-keted as food supplements and were boughtin a pharmacy. The report did not contain anyinformation on why the expectant and laterbreast-feeding mother hat taken the prepara-tions concerned. One of the preparationswas labelled on the package with the warn-ing: 'Do not use during pregnancy'. In the fur-ther course, a diagnosis of progressive famil-ial intrahepatic cholestasis was established.

Manifestations/courseThe child had been suffering from congenitalicterus. One or two weeks before admittanceto hospital, she developed a haematoma onher back. Two days before admittance to hos-pital, she suffered from nose bleeding. Hergeneral state deteriorated, and on admit-tance, the child was in a deeply comatouscondition. Due to an extended epidural haem-orrhage right, the haematoma was immedi-ately subjected to a neurosurgical relievingoperation.

Laboratory analyses revealed increased GOT253 U/L (reference range in children < 1 year:< 38 U/L), GPT 335 U/L (reference range inchildren < 1 year: < 36 U/L), bilirubin 3.5mg/dL (reference range total bilirubin new-borns < 13, adults < 1.1 mg/dL), AP 2340 U/L(reference range in children < 15 years. 110-700 U/L) and a Quick's value of 80 % (refer-ence range 70-100 %). Galactosaemia, ty-rosinaemia, alpha-1-antitrypsin deficiency,neonatal haemochromatosis, Niemann-Pickdisease, Alagille syndrome and infectioushepatitis could be excluded. Hepatopathypersisted in the infant. Liver biopsy was per-formed to exclude a progressive familial intra-hepatic cholestasis. The biopsy results re-vealed a picture of chronic hepatitis associat-ed with giant cell transformation, intrahepaticbilirubinostasis as well as marked septal fi-brosis and moderately floride inflammatory

27

activity. The histological picture was compati-ble with that of a protracted neonatal hepati-tis. Similar pictures had been seen in cases offamilial neonatal hepatitis, virus infections andalso of toxic damage resulting from medicinalproducts. The eosinophilic inflammatory com-ponent could be an indication of a previousexposure to medicinal products, e.g. thepreparations taken by the mother. Metabolicdiseases such as viral infections that may al-so cause neonatal giant cell hepatitis wereexcluded by clinical examinations. By meansof differential diagnosis, the investigatorsfound that a toxic damage had to be consid-ered as the most probable cause to explainthe clinical picture presented. Nevertheless, adiagnosis of progressive familial intrahepaticcholestasis was made in the further course.

NotesThe two products involved were preparationsused in traditional Chinese medicine (TCM). InChina and Japan, there are corresponding tra-ditional plant preparations that have been usedto improve the immune system, among otherpurposes. The two food supplements were ex-amined for hepatotoxic ingredients such aspyrrolizidine alkaloids and atractylosides. Ac-cording to the labels, both preparations containthe rhizome of an Atractylodes species, amongother ingredients. Both preparations containAtractylodes macrocephala (Bai Zhu) as an in-gredient in quantities of 12.4 % and 7.6 %, re-spectively. However, it could be detected only inthe capsules taken by the mother during herpregnancy. The concentration detected in acapsule was below 10 µg.

Phytopharmaceuticals are widely used and arelargely considered as harmless by the generalpopulation. However, on the whole, there hasbeen an increasing number of reports on hepa-totoxic effects of herbal medicines ranging fromminor changes in hepatic parameters to severe

liver damage. Particularly in South Africa, therehave been severe cases of poisoning by theplant, Callilepis laureola, containing atractylo-sides. Atractylosides are diterpene glycosidesthat may cause fatal hepatic and renal necrosisin the mammalian organism and also in humans.They inhibit the oxidative phosphorylation in theliver mitochondria. Cases of acute poisoning byplants containing atractylosides in humans havebeen described and may result in acute hepaticfailure. Also cases of renal damage have beendescribed. Knowledge is scarce concerningtheir chronic toxicity. In literature, there has beenno indication so far of intrauterine hepatic dam-age in an unborn child by atractylosides. InTCM, this plant has been described as having a"calming effect on restless foetuses". Bothpreparations seem to have been composed ac-cording to ancient traditional formulations ofTCM that are not intended for dietary purposesbut primarily for the treatment of a number ofphysical complaints, general weakness and al-so for an improvement of the immune system incases of HIV infection or cancer, among otherconditions.

Preparations that are predominantly intended tocure or relieve diseases must be considered asmedicinal products and not as foods. Also ac-cording to assessments made by the food con-trol authorities and the BfR, the products con-cerned have been suspected of belonging tothe category of medicinal products.

Evaluation of the case described:On the basis of the information given on thetemporal relationship between the mother's ex-posure and the onset of the infant's disease,and given the diagnosis of a progressive famil-ial intrahepatic cholestasis, a causal relationshipcannot be established. However, the elevatedtransaminase levels found initially are not typicalof a progressive familial intrahepatic cholesta-sis.


28

3.3.2.3 Ephedra alkaloids

Adverse reaction resulting from anephedra-containing productThe BfR received a report on a suspectedcase of an adverse reaction to a food supple-ment that had been submitted by a pharma-cy. A customer of the pharmacy had reportedto suffer from health complaints after takingthe preparation. Therefore, she was in doubtabout the safety of the product and contact-ed the pharmacist asking him to check thepackage. According to the letter receivedfrom the pharmacy, the product concerned isa food supplement originating from theNetherlands and containing 20 mg ephedraalkaloids. It is used for weight reduction pur-poses. The product had been unknown to theBfR. Already in 2002, a joint press releasehad been issued by the Federal Institute forHealth Protection of Consumers and Veteri-nary Medicine (BgVV) and the Federal Insti-tute for Drugs and Medical Devices (BfArM)giving a warning against an uncontrolled useof ephedra-containing products.

Manifestations/courseThe customer of the pharmacy had reportedto suffer from hot flashes, nervousness andsleep disorders after taking the preparation.She reported to simultaneously have experi-enced a euphoric effect that had been sopronounced that she found it difficult to re-frain from taking the product. The producthad also taken effect with regard to the in-tended weight reduction. However, these sideeffects and the effect of addiction raiseddoubt in her as to whether the product wassafe in terms of health.

NotesDue to the ephedra alkaloids contained in theproduct according to the information given bythe pharmacy, the product involved may have tobe considered as a medicinal product. The

herb, ephedra (Ephedra sinica) is a Chinesetherapeutic agent. It is available on the marketas a food supplement under the Chinese nameof Ma Huang. Being a natural source ofephedrine, it has pharmacological properties.Its effects include vasoconstriction, circulatorystimulation, rising blood pressure, CNS stimula-tion, strong dehydration, suppression of ap-petite and broncho-spasmolysis. Possible ad-verse reactions include dilatation of the pupils,nervousness, tremor, sweating, cardiac arrhyth-mia, hypertension and at high doses, also con-vulsive seizures and mental changes. Form andcharacter of the ephedra alkaloids naturallycontained in the plant are similar to those ofamphetamine. Therefore, products containingephedra have been classified as medicinalproducts to be sold by pharmacies only In thisway, quality, efficacy and safety of the productsmust be ensured.

Regrettably, products containing ephedra havebeen offered on the internet as food supple-ments or foods which is a practice avoiding au-thorization limitations and quality control. Theyare sold as appetite suppressant or remedy forhay fever. A study performed in the Netherlandson the quality and safety of ephedra-containingproducts revealed that in the majority of theproducts tested, the ephedra alkaloid quantitiesdetected were higher than those stated in thelabelling. Often, caffeine is added to the ingre-dients, increasing the effects of ephedra andthus the risk of harmful effects for the consumer.

In literature, there has been a great number ofreports on health impairment associated withthe use of ephedra-containing food supple-ments. After taking four tablets of a Ma Huangpreparation for alleged weight reduction, abodybuilder complained of severe pain in hisright thorax and suffered myocardial infarction.In another case, a 54-year-old female sufferedfrom hallucination associated with long-term useof food supplements containing ephedra (Clini-cal Toxicology 38 (2000) 5). Recently, it was re-

29

ported that a 22-year-old female was admittedto hospital presenting with tachycardia, nausea,tremor, abdominal pain and vomiting after hav-ing consumed a food supplement containingephedrine and caffeine. Electrocardiography re-vealed manifestations of ischaemia (ClinicalToxicology 41 (2003) 6). The Food and Drug Ad-ministration (FDA) being responsible for the ap-proval of medicinal products and food control inthe USA has announced that it will ban the saleof all products containing ephedrine alkaloids.Also in the Netherlands, the use of ephedrine inproducts other than those classified as medici-nal products has meanwhile been discontinued.

Already in 2002, the former BgVV has pointedout that such products should only be adminis-tered under control by a physician. Products forwhich a therapeutic effect is claimed in adver-tising have to be considered as medicinal prod-ucts. Therefore, such products require authori-zation by the Federal Institute for Drugs andMedical Devices (BfArM). Products lackingsuch authorization are not marketable. In con-trast, food supplements are foods of generalconsumption and must not be advertised byclaiming medicinal effects. Responsibility forsafety in terms of health rests with the manufac-turer. Due to the direct sale of ephedrine-con-taining products on the internet, a completecontrol by the national control authorities is im-possible.

Evaluation of the case described:On the basis of the information given on thetemporal relationship between the ingestion andthe occurrence of the manifestations observed,and in the absence of other causes, a causalrelationship has to be assumed in the case de-scribed.

3.3.3 Foods

3.3.3.1 Butterfish/Escolar

Caution when consuming smoked butter-fish/escolar A female patient and her partner experiencedhealth complaints after the consumption ofsuch fish that had been bought in a freshstate, stored in the refrigerator at 4 °C and un-dergone heat treatment. Manifestations per-sisted for four days. The patient becameaware of the problem when reading com-ments on health reports from Australia pub-lished by the BfR.


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Fig. 9: Butterfish/Escolar

Manifestations/courseBoth partners experienced gastrointestinalcomplaints in the form of diarrhoea that per-sisted for three to four days, with stools of oilyconsistency and dark yellow colour. After 48hours, a physician was consulted who sam-pled blood for examination and recommend-ed to drink large amounts of fluid. Since therewas no feedback from the physician consult-ed, it has been assumed that the results ofchemical examinations were not alarming. Noreport was received from the attending physi-cian.

NotesIn mid-2003, Australian health authorities report-ed health complaints associated with the con-sumption of escolar, also referred to as rudder-fish. 98 cases had been recorded since 1999.In a press release, the BfR informed the publicthat in particularly sensitive persons, the con-sumption of large amounts of fish of thespecies Lepidocybium flavobrunneum (escolar)and Ruvettus pretiosus (oilfish) both belongingto the Gempylidae family (German terms: "But-terfisch" or "Buttermakrele") may cause healthimpairments such as diarrhoea, abdominalcramping, vomiting and headache and warnedthat caution be observed when eating suchproducts. Experts have assumed as a presump-tive cause the presence of poorly digestible oreven indigestible wax esters that represent 90% of the oil or fat in these two fish species. Sofar, it has remained unclear whether these waxesters are the only causes responsible for suchillnesses or whether there are other factors play-ing a role as well. Such factors could possiblyinclude certain allergenic fish proteins or bio-genic amines (histamine, among others) thatmay form in fresh fish during extended storageperiods. Another unknown factor consists in thequantity of fish that must be consumed to pro-duce such health disturbances. The Germanterms of "Butterfisch" and "Buttermakrele" arecollective terms used in the marketing of severalhigh-fat fish species caught as by-catch indeep-sea fishing. In Germany, such fish hasbeen available on the market for several years inthe form of hot smoked fish cuts referred to as"geräucherte Buttermakrele", formerly"geräucherter Butterfisch". According to a studyby the Federal Research Centre for Fisheries inHamburg, waxy esters form more than 90 % ofthe oil or fat of the smoked "Butterfisch" and"Buttermakrele" marketed in Germany. The twocases described above are the first ones report-ed in Germany.

With regard to the toxicity of fishery productsassigned to the family of Gempylidae, an expert

opinion of 30 August 2004 by the Scientific Pan-el on Contaminants in the Food Chain (CON-TAM) stated that according to the EFSA (Euro-pean Food Safety Authority), it was not possibleto establish, on the basis of case reports re-ceived, an intake level for such fish which wouldnot lead to these adverse effects. By using ap-propriate practices of preparation, such as dis-carding the oil released, the occurrence of suchsymptoms may perhaps be avoided.

Evaluation of the case described:On the basis of the information given in the twoabove cases on the temporal relationship be-tween the ingestion and the occurrence of themanifestations observed, and in the absence ofother causes, the existence of a causal relation-ship has to be assumed.

Other cases involving butterfish/escolarReports by lay persons after publication of thearticle on the internet.

Case No. 4592/04After the consumption of 350 g of fish each,both partners suffered from severe diarrhoeapersisting for five to six days. Their stools con-tained large quantities of fat excreted in theform of globules. However, this type of diar-rhoea was not associated with pain as usual.

Case No. 4593/04One day after the consumption of 300 g of fish,diarrhoea with stools of a yellow colour andwaxy-oily consistency occurred that persisteduntil the next day. There were no other healthcomplaints.

3.3.3.2 Shiitake mushroom

Shiitake dermatitis (flagellate dermatitis)A dermatological outpatient department re-ported on a patient presenting with dermalmanifestations after the ingestion of at leasttwo raw shiitake mushrooms on two consecu-

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tive days. The patient's wife had also eatensuch mushrooms, however, without develop-ing any health complaints.

lar scales, its gills are white-brownish and itsspores colourless. It is highly valued as a fooddue to its excellent spicy taste. It has been as-cribed extensive favourable effects on health.Particularly in Chinese and Japanese cooking, ithas been a quite popular food. However, it isbeing cultivated and consumed in largeamounts also in Germany. It is the second mostpopular mushroom in the world next to the but-ton (table, white) mushroom. The beneficialproperties and effects ascribed to this "overallhealthy mushroom" include being a source ofprotein, potassium, zinc, vitamins B1, B2 and D,and more, an activator of the immune system, areducer of the cholesterol level, and havingfavourable effects on the immune system in thetreatment of cancer and AIDS. The main flavour-ing substances identified are sulfur compounds.They include lenthionine, tetrathiane and trithi-olane as well as the amino acid, eritadenine.

In a few individuals, consumption of thesemushrooms may have unpleasant conse-quences. Some hours after the meal, they willdevelop a so-called shiitake or flagellate der-matitis. The medieval penitents castigatingthemselves, also referred to as flagellants, lenttheir name to the clinical picture of the diseasebeing characterised by skin lesions which re-semble whiplashes on the trunk, the arms andlegs and on the neck. In the past, such skinmanifestations had been seen mainly after theingestion of inadequately cooked mushrooms. Itwas, therefore recommended to eat shiitakemushrooms only if they had been thoroughlycooked or fried. However, recent reports havesuggested that the type of preparation was ofno influence on the health complaints devel-oped by sensitive individuals.

The suspected cause of the intolerance reac-tion is the polysaccharide, lentinan, being a nat-ural component of the mushroom. The sub-stance appears to be heat-stable which is why itmay cause the dermatitis to develop also afterthe ingestion of well-cooked and fried mush-


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Fig. 10: Shiitake mushroom

Manifestations/courseThe changes of the skin observed were de-scribed by the physician on duty as linearerythema (similar to factitious urticaria)spreading over the entire body including thehead. In addition, disseminated seropapuleswere seen. Furthermore, the patient stated tofeel weak and abnormally tired. One monthlater, he still complained of skin irritation onmechanical stimulation. Treatment includedsystemic administration of cortisone which,however, was not taken by the patient. An al-lergy test was to be performed. The result re-mains to be seen.

NotesThe shiitake mushroom (Lentinus edodes) be-longs to the family of Tricholomataceae and is asaprophytic fungus which colonises deadwood. Its cap has a diameter of up to 20 cmand is of brownish-grey colour with flat triangu-

rooms. In spite of the large quantities of shiitakemushrooms cultivated world-wide, cases of shi-itake dermatitis have been very rare in Germany.Obviously, a sensitive reaction is developed by afew individuals only while the causes have notyet been elucidated. It has been assumed thatresponsible factors may also include unknownco-factors in addition to the amount ingestedand the type of preparation. Based on the num-ber of cases described, the risk for the con-sumer seems to be low, according to the pres-ent state of knowledge.

Mainly Japanese authors have reported aboutworkers on mushroom farms who had devel-oped an allergic alveolitis after inhalation of shi-itake spores. In this context, also cases of aller-gic contact dermatitis were mentioned thatcould be diagnostically confirmed by means ofthe patch test. As a sign of the allergic reaction,the skin rash was found to be associated witheosinophilia. Flagellate dermatitis was de-scribed for the first time in 1977 by Nakamura.In 1985, he reported on 30 cases observed inJapan within a period of nine years. They re-ferred to patients presenting with severe erythe-ma and pruritus after ingestion of the mush-rooms in traditional Asian dishes. All his patientssuffered from intensely pruritic, very smallpapules appearing closely together in lines.They reported these stripes to have developedwithin one or two days after the meal containingthe mushrooms. The stripes expressing a Koeb-ner phenomenon had obviously resulted fromscratching of the skin. The manifestations dis-appeared after 20–30 days. Until 1991, Naka-mura recorded a number of additional cases.Other authors reported on 58 patients present-ing with shiitake dermatitis during the1997–2001 period. In 33 of these cases, thedisease had developed after the ingestion ofsufficiently cooked/boiled mushrooms. In Ger-many, only single cases of this disease have oc-curred after consumption of this mushroom.

Evaluation of the case described:On the basis of the information given on thetemporal relationship between the ingestion andthe occurrence of the manifestations observed,and in the absence of other causes, a causalrelationship has been considered as probable.

3.3.4 Welding fumes

Moderate health impairment after weldingof plastic materialA 39-year-old worker reported to have weldedplastic material on two days for a period of al-together 17 hours. At his workplace, the ex-haust hood under which the work was per-formed was defective. In addition, he hadworn a defective gas mask for three hours.On the following evening, he experiencedhealth complaints that caused him to seekmedical advice in an outpatient department.

Manifestations/courseThe patient reported influenza-like symptomsin the form of arthralgia over the last 36hours. In addition, he suffered from severecough and fever. Inhalation was associatedwith marked pain, and he experienced dysp-noea and decreasing vitality. His cigaretteconsumption was stated to be ten cigarettesper day. The findings of an outpatient exami-nation performed two days later revealed thatthe patient was in a good general condition.Cardiovascular and pulmonary findings, aswell as the status of the other organs exam-ined were normal. No treatment was required,and the patient was recommended to avoidmajor physical strain and temporarily refrainfrom smoking.

NotesThe case described above was presumably dueto exposure to fumes from plastic materials re-sulting from non-compliance with occupationalsafety regulations. The manifestations describedwere largely compatible with those of polymer

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fume fever being similar to those of metal fumefever. During the processing of plastic materials,fluorocarbons in monomer or polymer form arereleased that may cause polymer fume fever. Itis characterised by chest pain, choking fits, drycough, fever, shivers and arthralgia. In mostcases, such manifestations will disappear withinone or two days after exposure. However, alsoprotracted pneumonia associated with agoniz-ing cough, retrosternal pain and general healthimpairment may occur. Chronic health damagehas not been recorded. Exposure to fluorine gasand possibly hydrocyanic acid could not be ex-cluded. Due to the short half-life of both sub-stances, a toxicological analysis was no longerpossible after two days had passed.

Health impairment after steel welding oper-ationsDuring the welding of antimagnetic steel, aworker had inhaled chromium and nickelfumes, in spite of wearing a respirator. Thisresulted in moderate health impairment re-quiring inpatient treatment.

insufficiency. An elevated carbon monoxideHb level (CO-Hb) was found. Pulmonaryoedema could be excluded by radiologicalexamination. The patient's condition improvedrapidly under oxygen supply and inhalatoryadministration of corticoids. He could be dis-charged in a symptom-free state on the fol-lowing day.

NotesThe above case of moderate health impairmentwas possibly associated with the formation ofchromium and nickel fumes during welding op-erations. A temporary partial respiratory insuffi-ciency receded rapidly under appropriate treat-ment. Chromium and nickel fumes may cause ir-ritation of the respiratory tract after inhalationalexposure. Single cases of respiratory diseaseafter occupational exposure to chromium dustand chromium compounds have been reportedwhich were associated with functional pul-monary disorders. Inflammatory and asthma-likelung diseases were reported to have occurredafter acute inhalational exposure. A sensitisingeffect on the respiratory tract has to be as-sumed.

3.3.5 Internal combustion engines

Industrial accident associated with an in-ternal combustion engineAt his workplace, a 33-year-old patient hadcut a concrete slab in an insufficiently venti-lated room. The disk grinder used was pow-ered by an internal combustion engine. Inspite of occasional breaks, the patient hadexperienced health complaints after twohours of working. He was monitored at an in-tensive care unit for one day.

Manifestations/courseAfter having worked for approximately twohours, the patient experienced vertigo and


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Fig. 11: Welding

Manifestations/courseTypical signs of inhalational poisoning weredescribed including dyspnoea at rest, verti-go, cough and two episodes of vomiting. Ablood gas analysis performed on the day ofadmission to the hospital revealed a partial

weakness. He could just leave the room be-fore his legs gave way. There was no loss ofconsciousness nor breathing difficulty. Hewas immediately subjected to intensive med-ical treatment. The carbon monoxide Hb level(CO-Hb) established on the patient's arrivalwas 29.1 %. Under high-dose oxygen supply(15 L/min), the CO-Hb decreased to 2.1 %.Since it remained unclear whether other toxicgases had also been present in the room, thepatient was monitored for another 24 hoursand administered dexamethasone. On the fol-lowing day, the patient could be dischargedin a good general condition.

NotesThe circumstances described by the patientraised doubts as to whether the required meas-ures of occupational safety had been compliedwith. Working in a poorly ventilated room withmachinery powered by an internal combustionengine involves a considerable health risk forthe operator. Possible organ damage due tooxygen deficiency may result in permanentbrain damage or even acute death from suffo-cation.

Combustion gases from internal combustion en-gines contain 4–11 % carbon monoxide. Carbonmonoxide is haemotoxic. It binds to haemoglo-bin to form carbon monoxide Hb (CO-Hb) bydisplacing the oxygen. The affinity of carbonmonoxide to haemoglobin is 300 times higherthan that of oxygen. This is the reason for thehazard posed by CO. Individuals differ consid-erably in their sensitivity to carbon monoxide inacute poisoning events. Because of their higherrespiration rate and more intense metabolism,adolescents and small and slim persons aremore at risk, as a rule, than adult and sturdypersons. Already at CO-Hb levels as low as 4 %, changes can be detected in psychomotortests. As in the case described above,headache, weakness and vertigo will as a ruleoccur, if ca. 30 % of the haemoglobin has be-come bound by carbon monoxide. Levels above

40–50 % will result in collapse and uncon-sciousness. If the respiration is deprived of75 % of the haemoglobin, the inevitable resultwill be death from suffocation. As compared toyounger individuals, CO-Hb concentrations that may lead to death become lower with in-creasing age. Carbon monoxide poisoning isparticularly often followed by late damage andsecondary diseases that may occur mainly assequelae of hypoxia experienced over a moreor less extended period. Frequent sequelae in-clude brain damage characterized by differentmanifestations because the central nervous system is highly sensitive in its response to hypoxia. Other sequelae recorded include my-ocardial necrosis and pneumonia. Also changesin the peripheral nerves or even paralysis havebeen reported. Similar to the central manifesta-tions, they are in part caused by primary vascu-lar damage.

The German MAK (maximale Arbeitsplatzkon-zentration – maximum admissible concentrationat the workplace) has been set at 30 mL/m3 (33mg/m3), and the BAT (Biologischer Arbeitsstoff-toleranzwert – biological threshold li

cases of poisoning reported by physicians -...

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