|Labeling of chemicals that are
toxic to reproduction
or ionizing radiation
Teratogens ( ancient Greek τέρας téras , German 'monster', in Plato a strange creature unlike the usual figures' ' deformity' and γένεσις génesis , German 'origin' ' emergence') are external influences that can cause malformations in the embryo : Chemicals ( fertile Substances ) as well as viruses and ionizing radiation . Substances that promote malformations are called teratogenic .
In the meantime, the term reproductive toxic (also reprotoxic ) is used by the legislator and instead of CMT substances ( carcinogenic - mutagenic- teratogenic) is now spoken of CMR substances . Under reproductive toxicant he combines the two cases ", the fertility affect" and "the child can damage the unborn" together.
Human embryos and fetuses react sensitively to teratogenic influences during pregnancy , especially in the period from the 18th to 85th day after fertilization . Teratogenic influences (possibly via pesticides, contaminated water, etc.) can also lead to adverse effects on other living beings.
The Teratology study the effect of potentially harmful substances. The reproductive toxicity test has been mandatory for new drugs since the Contergan scandal . This type of test is described in the article Toxicity determination . In the meantime, however, CMR testing has also become mandatory for all chemicals where there is an increased risk, for example during transport ( dangerous goods according to ADR) or during handling or free handling. For the latter, there are the following product labeling regulations.
Until the introduction of the global harmonized system for the classification and labeling of chemicals , chemical substances were classified in accordance with the European definition in Directive 67/548 / EEC , implemented in Germany by the GefStoffV . The following table compares the corresponding assignments:
|GHS||Directive 67/548 / EEC|
|Repr. 1A - H360F Can the fertility impairing||Repr. Cat. 1; R60 Can the fertility impairing|
|Repr. 1B - H360F May damage fertility||Repr. Cat. 2; R60 May impair fertility|
|Repr. 1A - H360D May cause harm to the unborn child||Repr. Cat. 1; R61 May cause harm to the unborn child|
|Repr. 1B - H360D May damage the unborn child||Repr. Cat. 2; R61 May cause harm to the unborn child|
|Repr. 2 - H361f Suspected of damaging fertility ,
or: H361d Suspected of damaging the unborn child
|Repr. Cat. 3; R62 Possible risk of impaired fertility ,
or: R63 Possible risk of harm to the unborn child
|Lact. - H362 Can infants via breast milk harm||R64 May cause harm to babies through breast milk|
- The additional letters differentiate the type of action. Lower case stands for likely effect. Combinations such as DF or Df are possible. The classification in 1A or 1B depends on the higher risk (D and / or F are classified in 1A and marked with H360).
In the GHS, the individual categories are classified as follows:
Substances are classified as toxic to reproduction category 1A if, based on findings in humans, they are known to impair the reproductive capacity of humans and / or cause developmental damage in the offspring. Substances in category 1A are marked with the GHS08 pictogram and the signal word danger .
Substances are classified in Category 1B if, based on animal studies, they are likely to impair the reproductive capacity of humans and / or cause developmental damage in the offspring. Substances in Category 1B are also identified with the GHS08 pictogram and the signal word Danger .
Substances are finally classified as category 2 toxic for reproduction if, based on findings in humans and / or animal studies, there is evidence of impairment of fertility or development, but the evidence is not conclusive enough for classification in category 1. Substances in Category 2 are also marked with the GHS08 pictogram and the signal word Caution .
Classification according to Directive 67/548 / EEC
Before the introduction of the GHS, Directive 67/548 / EEC regulated the classifications in Europe. The categories mean:
Category 1 substances are known to be teratogenic in humans. There are sufficient indications of a causal relationship between exposure of a person to the substance and damage to the fruit of the womb. Classification and labeling with hazard symbol T.
Category 2 substances should be viewed as teratogenic for humans. There is sufficient evidence to support the justified assumption that exposure of a person to the substance can lead to damage to the womb. This assumption is generally based on long-term tests and / or other relevant information. Classification and labeling with hazard symbol T.
Category 3 substances give cause for concern because of their possible teratogenic effects in humans. However, there is not enough information available for a satisfactory assessment. Some evidence is available from suitable tests, but these are not sufficient to classify the substance in Category 2. Classification and labeling with hazard symbol X.
- Category: Substance with a toxic effect on reproduction (list of substances available in Wikipedia, classified as H360, H360F, H360D, H360FD, H360Fd, H360Df or H362)
- Category: Substance suspected of being toxic to reproduction (list of substances available in Wikipedia and classified as H361, H361f, H361d, H361fd)
- Alcohol (embryopathy)
- Vitamin K antagonists
- Dioxins , especially the Seveso poison TCDD
- Retinoids (for acne therapy, mosquito and flea control agents, vitamin A )
- Thalidomide (trade name including Contergan )
- Tobacco smoke , active as well as passive smoking
- Rubella (see: Rubella During Pregnancy )
- Human Cytomegalovirus (CMV)
- Hepatitis B virus (HBV)
- Toxoplasma gondii
- X-rays - relevant for operating personnel in medical use
- Beta radiation and gamma radiation - relevant when dealing with radioactivity
- Cosmic radiation - high-energy radiation from space, relevant for astronauts and pilots; for the latter, however, somewhat reduced by the atmosphere.
- Thomas H. Shepard, Ronald J. Lemire: Catalog of Teratogenic Agents . 12th edition. Johns Hopkins University Press, Baltimore 2007, ISBN 0-8018-8742-9 , pp. 24 (English, limited preview in Google Book Search).
- Michael Hagner: Malformations, physical. In: Werner E. Gerabek , Bernhard D. Haage, Gundolf Keil , Wolfgang Wegner (eds.): Enzyklopädie Medizingeschichte. De Gruyter, Berlin / New York 2005, ISBN 3-11-015714-4 , p. 996 f .; here: p. 996.
- (PDF; 7 MB), accessed on January 28, 2017
- BAuA - Poster / Publications / Federal Institute for Occupational Safety and Health - The Globally Harmonized System (GHS) in the EU - Orientation aid. In: baua.de. August 2015, accessed December 24, 2015 .
- BAuA : Guide to the application of the CLP regulation THE NEW CLASSIFICATION AND LABELING SYSTEM FOR CHEMICALS ACCORDING TO GHS - BRIEF EXPLANATION - ( Memento of the original from August 10, 2015 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. (PDF file)