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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

No information on animal testing of Doré is available. Since, Doré composition profile 1 till composition profile 3 (Doré 1 – Doré 2) does not contain any constituent ≥ 0.1 % which is classified as a Carc. 1A or Carc. 1B carcinogen and ≥ 1 % which is classified as a Carc. 2 carcinogen, Doré 1 – Doré 3 must not be classified to possess carcinogenicity. For information on C&L for Doré - composition profile 4 till composition profile 5 (Doré 4 - Doré 5) please refer to the IUCLID endpoint summary "Carcinogenicity - Doré 4 - Doré 5".

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively. Since, Doré with the composition profile 1 – composition profile 3 (Doré 1 – Doré 3) does not contain any constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and no constituent ≥ 1 % classified for carcinogenicity Carc. 2, Doré 1 – Doré 3 is considered not to induce carcinogenicity. Hence, Doré 1 – Doré 3 does not have to classify to possess carcinogenicity (neither in Carc. 1A and Carc. 1B nor in Carc. 2) in accordance with Regulation (EC) 1272/2008.

Additional information

Substance specific information for the UVCB substance Doré is not available for the endpoint "Carcinogenicity". 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&Lof 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 carcinogen that trigger classification of the mixture” and respective rules of Regulation (EC) 1272/2006 section 3.6.3.1 “Classification of mixtures when data are available for all ingredients or only for some ingredients 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 carcinogenic Carc. 2, respectively) for carcinogenicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.