Registration Dossier
Registration Dossier
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EC number: 230-796-7 | CAS number: 7324-02-9
Endpoint summary
Administrative data
Description of key information
REACH_not sensitising | guinea pig (male/female) | Guinea pig maximisation test | Polymerised Indermil
No adverseeffects observed
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
All cyanoacrylates react rapidly in contact with water to form polymers (within seconds) giving an exogenous reaction. It is thus technically not possible to assess the skin sensitizing potential of the isolated allyl 2-cyanoacrylate monomer. During the test procedure then monomer reacts with the humidity of the air and on the skin to form the polymer (see waivers). This reaction is thus much faster than a penetration through skin, making it practically impossible to expose cells involved in an allergic reaction to the monomeric substance.
In guinea pigs according to a modified Buehler protocol have been conducted in order to assess the skin sensitizing potential of the substance n-butyl cyanoacrylate (structural surrogate) supplied in a commercial formulation.Polymerised Indermil (n-butylcyanoacrylate), elicited no reaction at the challenge (0% sensitization), following an induction phase. Therefore, as defined by the scoring system of Kligman, this is a Grade I reaction and the test article is classified as having weak allergenic potentiaL. A Grade I sensitization rate is not considered significant according to Magnusson and Kligman (1969, 1970).
Justification for classification or non-classification
Based on available information, it can be concluded that allyl 2-cyanoacrylate is not a skin sensitizer and thus needs no classification and labelling for skin sensitisation.
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