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Key value for chemical safety assessment

Additional information

Substance specific information for the UVCB substance "Lead bullion, Platinum Group metals rich" is not available for the endpoint "Genetic Toxicity". In order to meet the requirements for Annex VII till Annex X of Regulation (EC) 1907/2006, read across information from any constituents being relevant needs to be included. Due to the high number of constituents and variability in C&L of these constituents it was decided to use the classification information from the individual constituents and to calculate the resulting classification by using the “generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture.” and respective rules of Regulation (EC) 1272/2006 section 3.5.3.1 “Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture” with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.

For "Lead bullion, Platinum Group metals rich" one C&L entry (i.e., no C&L) for genetic toxicity was calculated.


Short description of key information:
No information on animal testing of "Lead bullion, Platinum Group metals rich" is available. Since, "Lead bullion, Platinum Group metals rich" neither contains any constituent ≥ 0.1 % classified as mutagen Muta. 1, nor any constituent ≥ 1 % classified as mutagen Muta. 2, the substance must not be classified to possess germ cell mutagenicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

"Lead bullion, Platinum Group metals rich" neither contains any constituent ≥ 0.1 % (w/w) classified as mutagen Muta. 1, nor any constituent ≥ 1 % (w/w) classified as mutagen Muta. 2. In conclusion, "Lead bullion, Platinum Group metals rich" does not meet classification criteria for mutagenicity and/or genotoxicity in accordance with Regulation (EC) 1272/2008.

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