Registration Dossier
Registration Dossier
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EC number: 701-129-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The study was performed to investigate bthe potential of the test item to induce gene mutations according to the plate incorporation test (Experiment I) and the pr-incubation test (Experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested in the following concentrations: 33, 100, 333, 1000, 2500, and 5000 µg/plate. Toxic effects (below the factor of 0.5), evident as reduction in the number of revertants, were observed at 1000 µg/plate and above with and without metabolic activation in nearly all strains used.In experiment I, reduced background growth was observed in strains TA 98 and TA 100 at 333 µg/plate and above without S9 mix and at 2500 µg/plate and above with S9 mix.No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
Short description of key information:
The test item is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
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