Registration Dossier

Administrative data

Description of key information

No information on animal testing for skin and eye irritation of “Slimes and Sludges, precious metal refining” - composition profile 3 is available. The approach followed on C&L of UVCB substances as irritant or corrosive to skin and eye in case where data are available on the constituents, but not on the UVCB substance as a whole, is based on the theory of additivity (CLP guideline, section 3.2.3.2.3.2, November 2013). Hence, the UVCB substance “Slimes and Sludges, precious metal refining” - composition profile 3 meets classification criteria as Skin Irrit. 2 and has to be labelled with H315 (Causes skin irritation). Furthermore, ”Slimes and Sludges, precious metal refining” - composition profile 3 requires classification as Eye Irrit. 2 in accordance with Regulation (EC) 1272/2008 and requires labelling with H319 (Causes serious eye irritation). 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Substance specific information for the UVCB substance of "Slimes and Sludges, precious metal refining" is not available for the endpoint "Irritation/Corrosion". In order to meet the requirements for Annex VII - Annex X of Regulation (EC) 1907/2006, read across information from any constituent 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 “theory of additivity" (Regulation (EC) No 1272/2008, section 3.2.3. and 3.3.3) 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" three C&L entries for irritation/corrosion (i.e., no C&L, irritation and corrosion) were generated. Each group is described in a separate endpoint study record and endpoint summary.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:
“Slimes and Sludges, precious metal refining” - composition profile 3 meets classification criteria for skin irritation Skin Irrit. (theory of additivity was applied) and requires labelling with H315 (causes skin irritation) as defined in Regulation (EC) 1272/2008.

Eye irritation:
“Slimes and Sludges, precious metal refining” - composition profile 3 meets classification criteria for Eye Irrit. 2 (theory of additivity was applied) and requires labelling with H319 (causes severe eye irritation) as defined in Regulation (EC) 1272/2008.

 

Respiratory irritation:

The generic term respiratory tract irritation (RTI) covers two different effects: (i) sensory irritation and (ii) local cytotoxic effects. The classification is usually covered under the endpoint specific target organs toxicity- single exposure (endpoint IUCLID 7.2) and - repeated exposure (endpoint IUCLID 7.5). Please refer to the endpoint summaries on acute toxicity and repeated dose toxicity for further information.