Registration Dossier

Administrative data

Description of key information

A key study was available for read-across substance CAS 68784 -08 -7 according to the Magnusson and Kligman Maximisation Test in guinea pigs. Induction with 0.5% suspension (intracutaneous) and 2 mL of a 25% suspension, followed by challenge with 2 mL of a 10% suspension of the test item - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the test item had no sensitising properties.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Guinea-pig maximisation testing

Read-across substance CAS 68784 -08 -7 (test item containing 39.80% active ingredient) was tested for its sensitising properties in the Magnusson and Kligman Maximisation Test in guinea pigs (Haferkorn, 2013c). A 0.5% suspension in aqua ad iniectabilia chosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 10 animals 24 and 48 hours after administration. 2 mL of a 25% suspension of the test item in aqua ad iniectabilia/animal chosen for the 2nd (topical) induction stage revealed a moderate and confluent erythema 48 hours and a discrete or patchy erythema 72 hours after start of exposure in all 10 animals. The challenge with 2 mL of a 10% suspension of the test item in aqua ad iniectabilia /animal - the maximum non-irritating concentration - revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. The vehicle control revealed no skin reactions. Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2).

Behaviour of the animals remained unchanged. Body weights were not influenced.

In conclusion, under the present test conditions, test item containing 39.80% active ingredient, was found to be not sensitising to guinea pigs in a test model according to MAGNUSSON and KLIGMAN.

 

Conclusion

- Based on the negative findings in the guinea-pig maximisation test, potential for skin sensitisation can be excluded.

- Further information supporting the absence of sensitisation potential is also provided in the read across justification for the N2 subgroup, showing that other guinea-pig maximisation was also negative. (Justification with data matrix separately attached in Section 13).

 

Justification for selection of skin sensitisation endpoint: Key study

 

Justification for classification or non-classification

As there was no indication for sensitisation from the Guinea-pig Maximisation test, classification for skin sensitisation is not needed according to the EC CLP Guidance (No. 1272/2008 of 16 December 2008).