Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-904-9 | CAS number: 546-56-5
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Route: .live2