Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-140-0 | CAS number: 3010-96-6
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
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
