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Division 3.5.2.2 For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories as shown in Table 3.5.1.

United Kingdom

Original text. Later amendments are not shown.

Table 3.5.1
Hazard categories for germ cell mutagens
CategoriesCriteria
CATEGORY 1:

Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.

Substances known to induce heritable mutations in the germ cells of humans.

Category 1A:

The classification in Category 1A is based on positive evidence from human epidemiological studies.

Substances to be regarded as if they induce heritable mutations in the germ cells of humans.

Category 1B:

The classification in Category 1B is based on:

  • positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or

  • positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. It is possible to derive this supporting evidence from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or

  • positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.

CATEGORY 2:

Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans

The classification in Category 2 is based on:

  • positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

    • somatic cell mutagenicity tests in vivo, in mammals; or

    • other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

Note: Substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.