Blue MOP 6314

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, "Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea

Pig - identification of Contact Allergens".

Test substance concentrations selected for the main study were based on the results of a preliminary study.

ln the main study, ten experimental animals were intradermally injected with a 0.2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (water). Approximately 24 hours before the epidermal

induction exposure all animals were treated with 10% SDS.

Two weeks alter the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.

in the challenge phase, skin reactions varying between grades 1 and 3, were observed in all experimental animals in response to the 50% test substance concentration. ln one control animal, a skin reaction of grade 1 was observed, 24 hours after challenge only.

Scaliness and eschar formation were seen in some treated skin sites among the experimental animals.

Blue staining was observed at all test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions. Taking into account the intensity and duration of the responses and comparing these with the

skin reactions seen in the control animals, it was considered that hypersensitivity to the substance had been induced in the experimental animals. The skin reaction, as observed in one control animal, was considered to be a sign of non-specific irritation.

These results indicate a sensitisation rate of 100 per cent. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), BLUE MOP 6314 should be labelled as: may cause sensitisation by skin contact (Skin sens. 1B).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008) a skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. A substance classified as skin sensitiser (Category 1) may be allocated to one of the two sub-categories 1A or 1B in accordance with the criteria given in Annex I: 3.4.2.2.1.4, Table 3.4.2.. If classification is based on results obtained from studies conducted in experimental animals, the test results from the LLNA, GPMT and the Buehler assay can be used directly for classification. Guidance values are presented in the CLP Regulation (EC 1272/2008) in Annex I: 3.4.2.2.3.2., Table 3.4.3 for classification in sub-category 1A and in Annex I: 3.4.2.2.3.3., Table 3.4.4 for classification in sub-category 1B.

Based on the results from Guinea Pig Maximisation Test performed, the substance induces a sensitisation rate of 100 %. Thus, the substance should be classified as skin sensitizer sub-category 1B (H317), according to the CLP Regulation (EC 1272/2008).