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Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

Substance specific information for the UVCB substance "Slimes and Sludges, precious metal refining" is not available for the endpoint "Toxicity to Reproduction" with respect to effects on fertility. 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&Lit 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 reproduction toxicants or for effects on or via lactation that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.7.3.1 “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.

In total, four different grades of "Slimes and Sludges, precious metal refining" (composition profile 1 - composition profile 4) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. Thus, for "Slimes and Sludges, precious metal refining" two C&L entries for carcinogenicity (i.e., no C&L and reproductive toxicant) were generated. Each group is described in a separate endpoint study record and endpoint summary.


Short description of key information:
No information on animal testing of “Slimes and Sludges, precious metal refining” is available. Since, "Slimes and Sludges, precious metal refining" (composition profile 1 - composition profile 3) does not contain any constituent ≥ 0.3 % which possesses reproduction toxicity and/or induce effects on or via lactation, the substance does not require classification for reproductive toxicity.

Effects on developmental toxicity

Description of key information
No information on animal testing of “Slimes and Sludges, precious metal refining” is available. Since, “Slimes and Sludges, precious metal refining” (composition profile 4) does not contain any constituent ≥ 0.3 % which possesses reproduction toxicity and/or induce effects on or via lactation, the substance does not require classification for reproductive toxicity.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

Substance specific information for the UVCB substance "Slimes and Sludges, precious metal refining" is not available for the endpoint "Toxicity to Reproduction" with respect to effects on developmental 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 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 reproduction toxicants or for effects on or via lactation that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.7.3.1 “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.

In total, four different grades of Slimes and Sludges, precious metal refining (composition profile 1 - composition profile 4) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. Thus, for "Slimes and Sludges, precious metal refining" two C&L entries for carcinogenicity (i.e., no C&L and reproductive toxicant) were generated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

Reproductive toxicity classification of UVCB substances is based on the presence of a constituent ≥ 0.3 % classified for reproductive toxicity. Since, "Slimes and Sludges, precious metal refining" (composition profile 1 - composition profile 3) is considered neither to induce reproductive toxicity nor induce effects on or via lactation, the substance does not have to be classified as such (neither in Cat. 1A and Cat. B nor in Cat. 2) in accordance with Regulation (EC) 1272/2008.

Additional information