Matte, precious metal

Endpoint summary

Description of key information

No information on animal testing of "Matte, precious metal" is available. However, Matte, precious metal 1 with a lead and lead compound content of ≥ 0.05 % and < 0.5 % and a cadmium sulfide content of ≥ 0.1 % and 1 % is considered to be toxic to specific target organs following repeated dosing via oral and inhalation route and should be labelled with STOT-RE 2; H373. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Substance specific information for the UVCB substance "Matte, precious metal" is not available for the endpoint "Repeated Dose 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 the mixture classified as a specific target organ toxicant that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.9.3.4 “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.

In total, tree different grades of "Matte, precious metal" (Matte, precious metal 1 – Matte, precious metal 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile.Thus, for "Matte, precious metal" two C&L entries (i.e., STOT RE 1 and STOT RE 2) for repeated dose toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
i.e., lead and lead compounds

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
i.e., cadmium sulfide

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
i.e., cadmium sulfide

Justification for classification or non-classification

Classification driver for STOT RE 2 are:

(i) Lead and lead compounds - oral

STOT RE 1; H372: C ≥ 0.5 %

STOT RE 2; H373: 0.05 % ≤ C < 0.5 %

(ii) Cadmium sulfide – oral and inhalation

STOT RE 1; H372: C ≥ 10 %

STOT RE 2; H373: 0.1 % ≤ C < 10 %

 

Classification of UVCB substances as being toxic to specific target organs is based on the presence of one or more constituents ≥ 1 % classified for STOT RE 1 and the presence of one or more constituents ≥ 10 % classified for STOT RE 2. However, for lead compounds and cadmium sulfide there are specific concentration limits given for STOT RE classification assigned by the lead industry and according to Regulation (EC) 1272/2008 Annex VI, respectively. According to this previously mentioned regulation “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification. Hence, the SCLs for lead compounds and cadmium sulfide are used for C&L of Matte, precious metal 1. Since, Matte, precious metal 1 contains ≥ 0.05 % but < 0.5 % lead and lead compounds and 0.1 – 1 % cadmium sulfide, Matte, precious metal 1 meets the classification criteria for STOT RE 2 (H373) as required in accordance with Regulation (EC) 1272/2008.

It is noted, that no registrants are using Matte, precious metal with a cadmium/cadmium sulphide content of ≥ 0.1 %. The maximum cadmium content in Matte, precious metal is 0.09% (for detailed information please refer to the ID card attached on IUCLID section 13).