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Administrative data

Key value for chemical safety assessment

Additional information

The key studies were performed in compliance with GLP and to appropriate OECD, EU and EPA OPPTS guidelines with a sufficient level of detail to assess the quality of the studies. The studies were performed to a good standard in line with an accepted, standardised guidelines and were assigned a reliability score of 1 using the criteria for assessing data quality as set out in Klimisch (1997).


Short description of key information:
Key study:- Bowles (2011) 'CN-3384A: Reverse mutation assay "Ames test" using Salmonella typhimurium and Escherichia coli' conducted in line with OECD Guideline 471 and EU Method B.13/B.14 and EPA OPPTS 870.5265.

Key study:- Morris (2011) 'CN-3384A: Chromosome aberration test in human lymphocytes in vitro' conducted in line with OECD Guideline 473 and EU Method B.10 and EPA OPPTS 870.5375.

Key study:- Flanders (2011) 'CN-3384A: L5178Y TK +/- Mouse lymphoma assay' conducted in line with OECD Guideline 476 and EU Method B.17 and EPA OPPTS 870.5300.

The substance was considered to be non-mutagenic under the conditions of all three tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The data do not indicate that any classification for genetic toxicity is required.

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