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Toxicological information

Carcinogenicity

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Description of key information

No information on animal testing of “Slimes and Sludges, precious metal refining" is available. However, “Slimes and Sludges, precious metal refining" (composition profile 3 - composition profile 4) contains constituents ≥ 0.1 % that are classified as a Carc. 1A carcinogen (i.e., As2O3 or NiCl2). Hence, “Slimes and Sludges, precious metal refining" (composition profile 3 - composition profile 4) meets classification criteria for carcinogenicity and requires classification as “Carc. 1A”, H350 (May cause cancer).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively. “Slimes and Sludges, precious metal refining" (composition profile 3) contains constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (i.e., NiCl2(inhalation)). “Slimes and Sludges, precious metal refining" (composition profile 4) contains constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (i.e., As2O3(oral)) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds). Hence, “Slimes and Sludges, precious metal" (composition profile 3 - composition profile 4) is considered to induce cancer and meets classification criteria as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Additional information

 Substance specific information for the UVCB substance "Slimes and Sludges, precious metal refining" is not available for the endpoint "Carcinogenicity". 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 the mixture classified as carcinogen that trigger classification of the mixture” and respective rules of Regulation (EC) 1272/2006 section 3.6.3.1 “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 carcinogen) were generated. Each group is described in a separate endpoint study record and endpoint summary

Justification for selection of carcinogenicity via oral route endpoint:
i.e., As2O3, lead and lead compounds

Justification for selection of carcinogenicity via inhalation route endpoint:
i.e., NiCl2