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Administrative data

Key value for chemical safety assessment

Additional information

In vitro Gene Mutation Study in Bacteria

The key study, Krul (2010) was submitted to fulfil the data requirement for in vitro mutagenicity in bacteria. The study was performed in accordance with standardised guidelines, OECD 471 and EPA OPPTS 870.5100 and in accordance with GLP. The study was both performed and reported to a high standard. As such it was deemed acceptable to assign the study a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997). Under the conditions of the test, the test substance did not induce an increase in revertants in the bacterial strains selected for the study.

In vitro Gene Mutation

The key study, Flanders (2012), was performed in accordance with standardised guidelines OECD 476, EU Method B.17 and EPA OPPTS 870.5300 and in line with GLP. The study was both performed and reported to a high standard. As such it was deemed acceptable to assign the study a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997). Under the conditions of the assay, the test material was determined not to be mutagenic in L5178Y TK+/- cells treated in vitro in either the presence or absence of metabolic activation.

In vivo Cytogenicity Test:

The key study, de Vogel (2004), was performed in accordance with the standardised guideline OECD 474 and in line with GLP. The study was reported to a high standard and was sufficient to assess the genotoxic and clastogenic potential of the substance. In accordance with the criteria for assessing data quality as outlined in Klimisch (1997), the study was assigned a reliability score of 1. The test substance was found not to induce chromosome damage, or damage to the mitotic spindle apparatus under the conditions of the test, and was concluded to be negative for genotoxicity and clastogenicity.


Justification for selection of genetic toxicity endpoint
As multiple studies are presented to address genetic toxicity, no one study was selected as the key study as they represent different types of genetic toxicity and are therefore not comparable.

Short description of key information:
In vitro Gene Mutation Study in Bacteria
Key study:- Krul (2010), OECD 471 and EPA OPPTS 870.5100; Negative up to precipitating concentrations.

In vitro Gene Mutation
Key study:- Flanders (2012), OECD 476, EU Method B.17, EPA OPPTS 870.5300; Negative up to precipitating concentrations

In vivo Cytogenicity Test
Key study:- de Vogel (2004), OECD 474; Negative up to 2000 mg/kg bw (limit concentration)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance with with criteria for classification and labelling as defined in Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD), the test material does not require classification for genetic toxicity.