Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.