Registration Dossier

Administrative data

Description of key information

In the key in vivo (non-LLNA) skin sensitisation study, conducted according to an appropriate OECD test guideline and in compliance with GLP,  the test material octaphenylcyclotetrasiloxane was reported to be not sensitising to skin (Eurofins, 2017).

Key value for chemical safety assessment

Skin sensitisation

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

In the key in vivo (non-LLNA) skin sensitisation study, conducted according to an appropriate OECD test guideline and in compliance with GLP,  the test material octaphenylcyclotetrasiloxane was reported to be not sensitising to skin (Eurofins, 2017).

Prior to each induction application, the left flank was cleared of hair (close-clipped). Then, a gauze patch was loaded with 0.5 g of 100% of the test substance. The patch was applied to the test area of approximately 2.5 x 2.5 cm and was held in contact with the help of an occlusive dressing for 6 hours. This procedure was repeated once a week at the same test area at weekly intervals for 3 weeks. The negative control group was treated the same way, but a dry gauze patch was applied to the test area.

At challenge, 14 days after the last induction application both flanks were cleared of hair (close-clipped). Then, 0.5 g of 100% of the test substance was applied to an area of approximately 2.5 x 2.5 cm on the right flank and was held in contact with the help of an occlusive dressing for 6 hours. A patch loaded with 0.5 mL of the vehicle was applied to an area of approximately 2.5 x 2.5 cm on the left flank at an untreated site (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours. Within approximately 21 hours after removing the patch, the challenge area was cleaned and cleared of hair by the use of a depilatory cream. Approximately 24 and 48 hours after removing the patch the skin reaction was observed and recorded. There was no evidence of sensitisation and the percentage of sensitised animals was 0%.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for octaphenylcyclotetrasiloxane, no classification for skin sensitisation is required according to Regulation (EC) No 1272/2008.