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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Substance specific information for the UVCB substance Doré is not available for the endpoint "Sensitisation". 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 skin sensitiser toxicant that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.4.3.3 “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 five different Doré grades (Doré 1 – Doré 5) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for Doré two C&L entries (i.e., no C&L and Skin Sens. 1) for skin sensitisation were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Migrated from Short description of key information:
No information on animal testing of Doré is available. Since, Doré composition profile 4 till composition profile 5 (Doré 4 - Doré 5) contains constituent ≥ 1 % (i.e., nickel) that is itself classified for skin sensitisation; the substance must be classified as being a skin sensitiser, Skin Sens. 1 (H317). It is noted that no sub-categorisation was performed. For information on C&L for Doré - composition profile 1 till composition profile 3 (Doré 1 - Doré 3) please refer to the IUCLID endpoint summary "sensitisation - Doré 1 - Doré 3.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
No information on animal testing of Doré is available. Since, Doré does not contain any constituent ≥ 0.1 % (w/w) that is itself classified for respiratory sensitization, the substance must not be classified as respiratory sensitiser.

Justification for classification or non-classification

Skin sensitisation

Doré 4 – Doré 5 possesses a skin sensitisation potential in accordance with Regulation (EC) 1272/2008. Hence, Doré 4 – Doré 5 does require classification as skin sensitiser in accordance with Regulation (EC) 1272/2008 Cat. 1 (H317).

Respiratory sensitisation

Furthermore, Doré does not contain any constituent ≥ 0.1 % (w/w) that is itself classified for respiratory sensitisation. Hence, the substance must not be classified as respiratory sensitiser in accordance with Regulation (EC) 1272/2008.