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Mutagenicity/Genotoxicity

Ability to cause or increase the rate of mutations, which are changes in genetic material in cells.

GHS Definition (6th edition):

[GERM CELL MUTAGENICITY] This hazard class is primarily concerned with chemicals that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, mutagenicity/genotoxicity tests in vitro and in mammalian somatic cells in vivo are also considered in classifying substances and mixtures within this hazard class.

In the present context, commonly found definitions of the terms “mutagenic”, “mutagen”, “mutations” and “genotoxic” are used. A mutation is defined as a permanent change in the amount or structure of the genetic material in a cell.

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, for example, specific base pair changes and chromosomal translocations). The term mutagenic and mutagen will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms.

The more general terms genotoxic and genotoxicity apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non-physiological manner (temporarily) alter its replication. Genotoxicity test results are usually taken as indicators for mutagenic effects.

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Hazard lists affecting this endpoint

Hazards affecting Mutagenicity/Genotoxicity
Hazard List Hazard Rating and Description GREENSCREEN® HPD C2C
EU - Annex VI CMRs
High hazard High confidence
Mutagen - Category 1A Priority List Mutagenicity (Red)
EU - Annex VI CMRs
High hazard High confidence
Mutagen - Category 1B Priority List Mutagenicity (Red)
EU - GHS (H-Statements) Annex 6 Table 3-1
High hazard High confidence
H340 - May cause genetic defects [Germ cell mutagenicity - Category 1A or 1B] Priority List Mutagenicity (Red)
EU - REACH Annex XVII CMRs
High hazard High confidence
Germ cell mutagens: Category 1A Priority List Mutagenicity (Red)
EU - REACH Annex XVII CMRs
High hazard High confidence
Germ cell mutagens: Category 1B Priority List Mutagenicity (Red)
EU - SVHC List
High hazard High confidence
Mutagenic - Banned unless Authorised Priority List Mutagenicity (Red)
EU - SVHC List
High hazard High confidence
Mutagenic - Candidate list Priority List Mutagenicity
EU - SVHC List
High hazard High confidence
Mutagenic - Prioritized for listing Priority List Mutagenicity
EU - Annex VI CMRs
Moderate hazard High confidence
Mutagen - Category 2 Priority List Mutagenicity (Red)
EU - GHS (H-Statements) Annex 6 Table 3-1
Moderate hazard High confidence
H341 - Suspected of causing genetic defects [Germ cell mutagenicity - Category 2] Priority List Mutagenicity (Red)
MAK
High to moderate hazard Low confidence
Germ Cell Mutagen 1 Priority List Mutagenicity (Red)
MAK
High to moderate hazard Low confidence
Germ Cell Mutagen 2 Priority List Mutagenicity (Red)
MAK
High to moderate hazard Low confidence
Germ Cell Mutagen 3a Priority List Mutagenicity (Red)
GHS - Australia
High hazard Low confidence
H340 - May cause genetic defects [Germ cell mutagenicity - Category 1A or 1B] Priority List Mutagenicity (Red)
GHS - Japan
High hazard Low confidence
H340 - May cause genetic defects [Germ cell mutagenicity - Category 1B] Priority List Mutagenicity (Red)
GHS - Korea
High hazard Low confidence
H340 - May cause genetic defects [Germ cell mutagenicity - Category 1] Priority List Mutagenicity (Red)
GHS - Malaysia
High hazard Low confidence
H340 - May cause genetic defects [Germ cell mutagenicity - Category 1A or 1B] Priority List Mutagenicity (Red)
GHS - New Zealand
High hazard Low confidence
Germ cell mutagenicity category 1 Priority List Mutagenicity
GHS - Australia
Moderate hazard Low confidence
H341 - Suspected of causing genetic defects [Germ cell mutagenicity - Category 2] Priority List Mutagenicity (Red)
GHS - Japan
Moderate hazard Low confidence
H341 - Suspected of causing genetic defects [Germ cell mutagenicity - Category 2] Priority List Mutagenicity (Red)
GHS - Korea
Moderate hazard Low confidence
H341 - Suspected of causing genetic defects [Germ cell mutagenicity - Category 2] Priority List Mutagenicity (Red)
GHS - Malaysia
Moderate hazard Low confidence
H341 - Suspected of causing genetic defects [Germ cell mutagenicity - Category 2] Priority List Mutagenicity (Red)
GHS - New Zealand
Moderate hazard Low confidence
Germ cell mutagenicity category 2 Priority List Mutagenicity
MAK
High to low hazard Low confidence
Germ Cell Mutagen 3b Mutagenicity (Red)
MAK
High to low hazard Low confidence
Germ Cell Mutagen 5 Mutagenicity (Red, Yellow, or Green)
US EPA - PPT Chemical Action Plans
High hazard
Mutagenicity - TSCA Criteria met Mutagenicity
DK-EPA - Danish Advisory List
Potential concern hazard
Muta. 2; H341 - Suspected of causing genetic defects (modeled)
EU - Manufacturer REACH hazard submissions
Potential concern hazard
H340 - May cause genetic defects (unverified) [Germ cell mutagenicity - Category 1A or 1B]
EU - Manufacturer REACH hazard submissions
Potential concern hazard
H341 - Suspected of causing genetic defects (unverified) [Germ cell mutagenicity - Category 2]