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 1, 1.1 Ability of a chemical to cause changes in the genetic material. Glossary by the Center for Alternatives to Animal Testing, Johns Hopkins University, URL: http://caat.jhsph.edu/publications/animal_alternatives/glossary.htm 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT For some endpoints, especially mutagenicity and carcinogenicity, the available information may not enable a threshold, and therefore a DNEL, to be established. Annex I, Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations). The term ‘mutagenic’ and ‘mutagen’ is used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms. 2015-01-21 1, 1.2 An agent giving rise to an increased occurrence of mutations in populations of cells and /or organisms. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT The mixture shall be classified as a mutagen when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 mutagen and is present at or above the appropriate generic concentration limit as shown in Table 3.5.2 for Category 1A, Category 1B and Category 2 respectively. Annex I, Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 2015-01-21 1, 1.1 Substances known to be mutagenic to humans. There is sufficient evidence to establish a causal association between human exposure to a substance and heritable genetic damage. Annex VI to the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT Approximate equivalence in the GHS classification scheme and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: germ cell mutagenicity category 1A 2015-01-21 1, 1.1 Substances which should be regarded as if they are mutagenic to humans. There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in the development of heritable genetic damage (generally on the basis of appropriate animal studies). Annex VI to the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT Approximate equivalence in the GHS classification scheme and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: germ cell mutagenicity category 1B 2015-01-21 1, 1.1 Substances which cause concern for humans owing to possible mutagenic effects. There is evidence from appropriate mutagenicity studies, but this is insufficient to place the substance in Category 2. Annex VI to the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT Approximate equivalence in the GHS classification scheme and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: germ cell mutagenicity category 2 2015-01-21 1, 1.2 Ability of a chemical to cause heritable changes in the genetic material in germ cells. UNECE, 2004 4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 2015-01-21 1 Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1 or 2, in accordance with Directive 67/548/EEC, are substances of very high concern2. They may be included in Annex XIV and by that made subject to authorisation requirement. CMRs may be non-threshold (i.e. it is not possible to define a Derived No-Effect Level (DNEL)) or threshold (i.e. it is possible to define a DNEL). 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21