Registration Dossier

Administrative data

Description of key information

No information on animal testing of “Slimes and Sludges, precious metal refining" is available. “Slimes and Sludges, precious metal refining" 3 contains ≥ 1 % nickel chloride (specific concentration limits of nickel chloride; see "justification for classification and non-classification" below). Hence, “Slimes and Sludges, precious metal refining" 3 meets classification criteria for STOT RE 1 via the inhalation route.
“Slimes and Sludges, precious metal refining" 4 contains ≥ 1 % nickel chloride and ≥ 0.3 % lead and lead compounds relevant for C&L of grade 4. For all constituents there are specific concentration limits (SCLs) given for STOT RE classification (see discussion). Based on the SCLs and the specific rules for mixtures of Regulation (EC) 1272/2008 “Slimes and Sludges, precious metal refining" 4 requires classification as STOT RE 1.

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 - 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 "Slimes and Sludges, precious metal refining"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, 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 specific target organs toxicity (i.e., no C&L and STOT RE 1) were generated. 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. It is noted that lead and lead compounds are only considered for Slimes and Sludges, precious metal refining grade 4- The lead and lead compound content in Slimes and Sludges, precious metal refining grade 3 is below the cut-off value for C&L of mixtures in accordance with Regulation (EC) 1272/2008.

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

Justification for classification or non-classification

Classification driver for STOT RE 1 are:

(i) Lead and lead compounds - oral (grade 4)

According to the self-classification of lead compounds thespecific concentration limits (SCL) for STOT RE classification are as follows:

STOT RE 1; H372: C ≥ 0.5%

STOT RE 2; H373: 0.05% ≤ C < 0.5%

(ii) Nickel dichloride – inhalation (grade 3 & 4)

According to the self-classification of nickel chloride the specific concentration limits (SCL) for STOT RE classification (inhalation) are as follows:

 

STOT RE 1; H372: C ≥ 1 %

STOT RE 2; H373: 1 % ≤ C < 7 %

 

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. However, for lead compounds and nickel dichloride there are specific concentration limits given for STOT RE classification assigned by the lead/nickel industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification.

 

The classification driver for STOT RE classification of “Slimes and Sludges, precious metal refining” 3 is nickel dichloride in concentration relevant for C&L as STOT RE 1. The classification drivers for STOT RE classification of “Slimes and Sludges, precious metal refining” 4 are nickel dichloride and lead and lead compounds in concentration relevant for C&L as STOT RE 1.

Hence, “Slimes and Sludges, precious metal refining” 3&4 meets classification criteria as STOT RE 1 and requires labelling with H372 (causes damage to organs).