Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

This study was carried out based on the guidelines in the EC Commission Directive 96/54/EC, Part B.6 and OECD number 406 and EPA OPPTS 870.2600. The test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 20% concentration of the test substance. Five control animals were similarly treated with the vehicle (polyethylene glycol) alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application, all animals were challenged with a 20% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the test article had caused skin hypersensitivity in the guinea pig, since no response were observed in the experimental animals in the challenge phase. This result indicates a sensitization rate of zero percent. Based on these results and according to the EC criteria for classification and labeling requirements for dangerous substances and preparations, the test article does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact.


Migrated from Short description of key information:
A Guinea Pig Maximization skin sensitization study was conducted on C4 Alcohol. The results of the study was:

Non-sensitizing in a Guinea Pig Maximization Test according to OECD 406.

Justification for classification or non-classification

Criteria for classifying as a dermal sensitizer are not met.