Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

IN VITRO

In a reverse gene mutation assay in bacteria (BASF, 1992), strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium were exposed to C5 acetate (purity 98.8%; solvent: DMSO) at concentrations of up to 5000 µg/plate in the presence and absence of mammalian metabolic activation (Standard Plate test: 4-5000 µg/plate; Preincubation Test: 4-1000 µg/plate; Liquid suspension Assay: 4-1250 µg/plate).

C5 acetate was tested up to cytotoxic concentrations. There was no evidence of mutagenicity in any tester strain in the Standard Plate test with and without metabolic activation; in any tester strain in the Preincubation Test with and without metabolic activation; in any tester strain in the Liquid Suspension Assay with metabolic activation; and in tester strains TA 1535 and TA1537 in the Liquid Suspension Assay without metabolic activation. Controversial results were observed in the Liquid Suspension Assay without metabolic activation for TA 98 (slightly enhanced figures at 500 - 1000 µg/plate; factor 1.8-2.0; this could not be confirmed by a second experiment). Positive reaction was observed in the Liquid Suspension Assay without metabolic activation for TA100 from about 250 µg/plate (factor 1.8) onward with an increase in the number of mutant colonies by a factor of 8.1 at 1250 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. Overall, there was no evidence of induced mutant colonies over background.

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.

 

IN VIVO

No data.



Short description of key information:
IN VITRO
Not mutagenic in bacteria:
- not mutagenic in the standard Ames Test (Standard Palte Test and Preincubation Test)
- mutagenic in a modified Ames Test (Liquid Suspension Assay).

IN VIVO
No data are available.

Endpoint Conclusion:

Justification for classification or non-classification

There is no need to classify C5 acetate for mutagenicity according to the Directive 67/548/EC or GHS criteria.