Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames TEST: Negative with and without S9.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the REACH regulation (EC n. 1907/2006), annex VII, the information required for registration in tonnage band 1-10 t/y regarding mutagenicity is in vitro gene mutation study in bacteria. Further mutagenicity studies shall be considered in case of a positive result. The test item was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium (TA98, TA100, TA1535, TA 1537) and Escherichia coli WP2 uvrA pKM101 with and without metabolic activation S9 according to OECD TG 471. In all strains the induction factor (IF) did not exceed 2 (TA98, TA100, ECWP2) or 3 (TA1535, TA1537), hence the substance is not considered mutagenic under the test conditions applied. No further investigation regarding the mutagenicity are required.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) a mutation means 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 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 test substance is not capable to induce gene mutation as demonstrated by negative result of AMES on the test item with and without metabolic activation. According to the REACH regulation (EC n. 1907/2006), annex VII for registration in tonnage band 1-10 t/y if in vitro gene mutation study in bacteria is negative no further investigation regarding the mutagenicity are required and the substance is considered not mutagenic according to the CLP Regulation (EC n. 1272/2008).