Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The key study for bacterial mutagenicity (Verspeek-Rip, 2003) was conducted according to the OECD 471 guideline using both Salmonella typhimurium and Escherichia coli. The test was conducted using test concentrations up to 5000 µg per plate, in both the presence and absence of metabolic activation. Standard positive and negative controls were employed concurrently.

Under the conditions of the test the registered substance was found not to induce mutation in bacterial cells in both the presence and absence of metabolic activation.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).

The key study for mammalian in vitro mutagenicity (Nakagawa, 2004) was conducted according to the OECD 473 guideline using the Chinese Hamster Lung (CHL/IU) cell line. Test concentrations of 313, 625, 1250, 2500 and 5000 µg/ml were used in the test. Standard positive and negative controls were employed concurrently.

Under the conditions of the test the registered substance did not enduce mutations in mammalian cells either in the presence or absence of metabolic activation.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).


Short description of key information:
The registered substance induced negative results in the key studies for bacterial mutagenicity (Verspeek-Rip, 2003) in both the presence and absence of metabolic activation, and also in the key study for mammalian in vitro mutagenicity (Nakagawa, 2004) in both the presence and absence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based upon the key information presented the registered substance does not fulfill the criteria for classification according to EC Regulation 1272/2008 or directive 67/548/EEC.