Registration Dossier

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

 

The potential for 2,2,4,4-tetramethyl-1,3-cyclobutanediol to induce skin sensitization is well understood with the key study consisting of an OECD guideline 406 study that followed GLP assurances. In that study a 75% w/w mixture of the test substance in mineral oil was topically applied to 20 guinea pigs, once each week for a three-week induction period. Twenty-seven days after the first induction dose, a challenge dose of the test substance at its highest non-irritating concentration (38% w/w mixture in mineral oil) was applied to a naive site on each guinea pig. A naive control group (ten animals) was treated with the test substance at challenge only. Approximately 24 and 48 or 73 hours after each induction and challenge dose, the animals were scored for erythema. No evidence of sensitization was seen in any animal at any time. Accordingly, based on the results of this study, the test substance is not considered to be a contact sensitizer.

Justification for classification or non-classification