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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 605-318-9 | CAS number: 163206-31-3
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:
The Buehler epicutaneous patch test was conducted on male guinea pigs according to OECD guideline 406 with a test item containing 75 % active ingredient. A 50 % test substance formulation was used for first to third induction and a 25 % test substance formulation for challenge, based on previously performed range finding tests (highest dose to cause mild irritation for induction, highest non-irritating dose for challenge). 24 and 48 hours after challenge exposure (30 and 54 hours after the beginning of the challenge) the treated sites were assessed.
The challenge with the 25 % test item formulation led to slight skin effects (grade 1) in the test item group in 1/20 animals after 24 hours and in 1/20 animals after 48 hours. Slight skin effects (grade 1) were also seen in 1/10 of the animals in the control group after 24 and 48 hours. The total number of reacting animals was 1/10 (10 %) in the control group and 2/20 (10 %) of the animals in the test item group.
In summary, by comparing the effects in the test item group and the control group it can be concluded that under the conditions used the test item exhibits no skin-sensitization potential.
Migrated from Short description of key information:
Buehler test, Guinea pig: negative
Justification for selection of skin sensitisation endpoint:
Only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification on skin sensitisation is warranted according to Regulation (EC) No 1272/2008, Annex I.
Although a commercial product with a 75 % concentration of active ingredient was used in the available assay on sensitisation (Buehler), the negative test result should also be valid for the pure substance, as the test item was tested at a concentration that was the highest to cause mild irritation for induction and at a concentration that was the highest non-irritating concentration for challenge. Higher concentrations would not have been appropriate.
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.
