Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation study in bacteria:

The test item was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and TA 102, performed according to OECD TG 471. Doses of up to and including 5000 µg per plate did not produce bacteriotoxic effects. Substance precipitation occurred at 5000 µg per plate. The test material was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test. Positive controls increased the mutant counts to well over those of the negative controls, thus demonstrated the system´s sensitivity.

In vitro micronucleus study:

The test item was examined for mutagenic activity (chromsome breakage and misdistribution of chromosomes) in the in vitro micronucleus test using Chinese Hamster V79 cells in accordance to OECD Guideline 487. The negative control and appropriate positive controls with known mutagens demonstrated the suitability and sensitivity of the test system. The test item showed no biologically relevant increase in the frequency of micronucleus containing V79 cells in the absence (both pulse and continuous treatment) or in the presence of S9 mix (pulse treatment) when tested up to cytotoxic concentrations.

In vitro gene mutation study in mammalian cells

The test item was tested in an in vitro gene mutation assay in V79 cells (HPRT) according to OECD TG 476. The vehicle control and appropriate positive controls with known mutagens demonstrated the sensitivity of the test system and the activity of the metabolic activation system. No substantial and reproducible dose dependent increase of the mutation frequency was observed for the test item in the cultures with and without S9 mix when tested up to cytotoxic concentrations. Based on these results the test substance is considered to be non-mutagenic in this V79/HPRT test under the conditions tested.


Justification for selection of genetic toxicity endpoint
No study was selected since all three in vitro mutagenicity studies were negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available study results (negative in Ames test, HPRT test and micronucleus test, in vitro) a classification according to EU-Directive 67/548/EEC, Annex VI and according to Regulation (EC) No 1272/2008, Annex I is not warranted.