Registration Dossier
Registration Dossier
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EC number: 202-288-5 | CAS number: 93-92-5
Endpoint summary
Administrative data
Description of key information
Data from maximization studies conducted in humans at up to 4% shows a lack of sensitization.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Migrated from Short description of key information:
Due to the availability of suitable human sensitisation data (see IUCLID dataset section 7.10.4 'Sensitisation data (humans)' below, there is no justification in performing an in vivo animal sensitisation test on the basis that the results will be superseded by the availability of suitable human data. This study is also not required on animal welfare grounds.ustification in performing an in vivo animal sensitisation test on the basis that the results will be superseded by the availability of suitable human data. This study is also not required on animal welfare grounds.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The key study for skin sensitisation (presented in IUCLID dataset section 7.10.4 'Sensitisation data (humans)) indicates that the test substance is not sensitising when tested at a 4% concentration in a human bioassay study conducted in line with the Maximisation test for identifying contact allergens in humans. The substance is therefore not classified un accordance with Directive 67/548/EEC and Regulation 1272/2008.
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