Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No information on animal testing for skin and eye irritation of Doré 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). Since, Doré does not contain any constituent ≥ 1 % (w/w) (in sum) classified as skin corrosive Skin Corr. 1A, 1B and 1C and/or ≥ 10 % (w/w) (in sum) classified as skin irritant Skin Irrit.. 2, the UVCB substance Doré must not be classified to possess skin irritant properties or skin corrosion.
Furthermore, since, Doré does not contain any constituent ≥ 1 % (w/w) (in sum) classified as Eye Damage. 1 (in sum) and ≥ 3 % (w/w) (in sum) classified as Eye Irrit. 2, the UVCB substance Doré must not be classified to possess eye irritant properties or eye corrosion.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

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

Additional information

Substance specific information for the UVCB substance Doré 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, five different grades of Doré (Doré 1 – Doré 5) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. For Doré only one C&L entry (i.e., no C&L) is needed for irritation/corrosion properties of Doré 1-5, since either the individual constituents are not classified for irritation/corrosion or the sum of individual constituents that are classified for irritation/corrosion are not above the cut-off values given in Regulation (EC) 1272/2008.

Justification for classification or non-classification

Skin irritation:
The UVCB substance Doré does not possess a skin irritation potential in accordance with Guidance on the application of the CLP criteria Version 4.0 - November 2013 (theory of additivity was applied). Hence, Doré does not require classification as a skin irritant according to Directive 67/548/EEC and Regulation (EC) 1272/2008.

Eye irritation:
The UVCB substance Doré does not possess an eye irritation potential in accordance with Guidance on the application of the CLP criteria Version 4.0 - November 2013 (theory of additivity was applied.

Hence, Doré does not require classification as an eye irritant according to Directive 67/548/EEC and 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 organ 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.