Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

AMES test: negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance did not show mutagenic activity in any of the strains used in the AMES test according to the OECD Guideline 471. The positive controls were valid.

Justification for classification or non-classification

According to the CLP Regulation (EC) No. 1272/2008, for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories depending on whether they are:

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

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

Based on the av<ilable experimental data on genetic toxicity, the substance is not classified for genetic toxicity according to the CLP Regulation (EC) No. 1272/2008.


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