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Administrative data

Key value for chemical safety assessment

Additional information

Additin E459 was investigated for point mutagenic effects according to OECD TG 471 and GLP using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and in the absence of a metabolic activation systen. The test was performed using the the plate incorporation and the pre-incubation methodology with doses up to and including 5000 µg/plate.

None of the 5 strains used showed a dose-related and biologically relevant increase in mutant counts over those of the solvent controls in the plate incorporation test. This applied both to the tests with and without S9-mix and was confirmed by the results of the pe-incubation trials.No bacteriotoxic effects or precipitations of the substance were observed. The positive controls increased mutant counts to well over the solvent controls, and thus demonstrated the sysem's sensitivity and the activity of the S9-mix.

Therefore, Additin E 459 was considered to be non-mutagenic in the Ames test under the conditions reported.


Justification for selection of genetic toxicity endpoint
The available study is performed according to OECD Guideline No. 471 under GLP conditions and was evaluated with Klimisch score 1

Short description of key information:
Additin E459 was investigated for point mutagenic effects according to OECD TG 471 and GLP using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and in the absence of a metabolic activation systen. The test was performed using the the plate incorporation and the pre-incubation methodology with doses up to and including 5000 µg/plate. Additin E 459 was considered to be non-mutagenic in the Ames test under the conditions reported.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data no classification is required.