Registration Dossier
Registration Dossier
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EC number: 484-460-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization studies on several oximes and oxime silanes have been conducted. MEKO was shown to be a skin sensitizer in guinea pig studies. Methylisobutyl ketoxime (MIBKO) was not a skin sensitizer in guinea pigs. MEKO-containing oxime silanes have produced skin sensitization reactions in guinea pigs similar to MEKO itself. Oxime silanes containing MIBKO did not produce skin sensitization in guinea pigs. These data indicate the skin sensitization potential of the oxime silanes are due to the oxime and not the silicone containing moieties. Due to the differences in skin sensitization potential between MEKO and MIBKO, the skin sensitization potential of MPKO was evaluated. Originally, we conducted a local lymph node assay (LLNA) as this is the preferred methodology. In this study, we used MEKO as the positive control. Neither MPKO nor MEKO were positive in the LLNA. Since MEKO was also negative in the LLNA, we conducted another skin sensitization study on MPKO using a guinea pig method which produced skin sensitization reactions with MEKO. MPKO was not a skin sensitizer in guinea pigs. Currently, we do not know why MEKO was negative in the LLNA. However, the LLNA methodology evaluated the induction phase but not the elucidation phase of skin sensitization. The LLNA does not appear to be an appropriate method to evaluate the skin sensitization potential of oximes. Due to the rapid hydrolysis of OS1600 to MPKO and the similarities in response between other oximes and their associated oxime silanes, it is appropriate to use the MPKO data to evaluate the skin sensitization potential of OS1600.
Migrated from Short description of key information:
Not a skin sensitizer in the guinea pig (Beuhler) or LLNA studies
Justification for classification or non-classification
MPKO, the hydrolysis product of OS1600, was not a skin sensitizer in animal models. Classification is not necessary.
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