Registration Dossier
Registration Dossier
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EC number: 700-957-0 | CAS number: 1141852-17-6
Endpoint summary
Administrative data
Description of key information
Based on the results of an LLNA, the registered substance was concluded to be a skin sensitiser. As the LLNA is not considered a suitable test for silicone materials, the result is disregarded and further testing to address this endpoint has been initiated.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
- Additional information:
The skin sensitising potential of Y-15866 was investigated in a Local Lymph Node Assay (LLNA) in mice according to OECD guideline 429 and in compliance with GLP (Vogel, 2010). Based on the results, stimulation indices of 4.75, 2.57 and 1.71 were calculated for the treatment concentrations of 100%, 50% and 25%, respectively. The estimated concentration for a stimulation index of 3 (EC3) was 59.9%. No local or systemic toxicity and no effects on body weights were observed. The historical positive control hexyl cinnamic aldehyde confirmed the sensitivity and reliability of the experimental technique (SI = 3). Under the above mentioned conditions, the test substance was found to be a sensitiser in the LLNA.
The suitability of the murine local lymph node assay (LLNA) to assess skin sensitisation potential of Si-containing chemicals was found to be questionable (“An assessment of the skin sensitisation hazard of a group of polyfunctional silicones using a weight of evidence approach”, Petry et al, Regulatory Toxicology and Pharmacology Volume 64, Issue 2, November 2012). In this study, 4/5 polyfunctional silicone materials showed weak to moderate skin sensitisation potential in the LLNA, but all were negative in the guinea pig maximization test (GPMT). Considering all existing information including physico–chemical and structure activity and animal data as well as existing human experience from silicone exposures at the workplace or their use in cosmetic products, the weight of evidence suggested that none of the examined silicone materials represents a significant skin sensitization hazard to humans.
Based on the fact that Y-15866 also showed a weakly positive response in the LLNA (EC3 = 59.9%) and based on its similarities in chemical structure to the investigated substances (Si-containing chemicals), it is concluded that the outcome of the current LLNA may not be reliable. Therefore further investigations are initiated to allow a final conclusion for this endpoint.
Justification for classification or non-classification
The available data on the skin sensitising potential of Y-15866 is not reliable and therefore further testing is needed to conclude on the classification for skin sensitisation according to Regulation (EC) 1272/2008.
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