Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Mutagenic (Ames)

Non-mutagenic (chromosome aberration, hprt)

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC) No. 1272/2008 substances can be allocated in two categories for germ cell mutagenicity: Category 1- subcategories 1A and 1B, Category 2.

According to the Guidance on the Application of CLP criteria (version 5.0, July 2017): 'in vitro results can only lead to a Category 2 mutagen classification in a case where there is support by chemical structure activity relationship to known germ cell mutagens. In the case where there are also negative or equivocal data, a weight of evidence approach using expert judgement has to be applied.'

Due to the positive result of the in in-vitro gene mutation study in bacteria (confirmed by other studies), further investigation on the potential of the substance to induce gene mutations was done in the in in-vitro chromosome aberration study in V79 cells. The gene mutation study in mammalian cells was also considered as necessary due to the negative result of the chromosome aberration test. According to the CLP Regulation: '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'. The negative result in the in-vitro gene mutation study in mammalian cells suggests a non classification for mutagenicity.