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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 612-722-9 | CAS number: 61931-07-5
Endpoint summary
Administrative data
Description of key information
not skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitizing potential of substance was tested after intradermal injections and cutaneous applications in ten male and ten female Albino Guinea Pigs, to the method established by B. Magnusson and A. Kligman *. The intradermal induction was performed at the concentration of 2.5 % in distilled water. In the epicutaneous induction and in the challenge patch with undiluted test item were used. The behaviour of the animals was not influenced by the treatment. Due to the staining of the skin, no local reaction was noted 24 h and 48 h after removal of the challenge patch test.
Skin samples of both flanks were taken and fixed in formalin 10 %. Histological examination of the skin samples did not reveal evidence of a sensitization reaction.
In conclusion, under the experimental conditions, the test sample did not provoke any cutaneous sensitization in the guinea pig.
*MAGNUSSON B. - KLIGMAN A.M. The identification of contact allergens by animal assay "The guinea pig maximization test". J. Invest. Derm. 1969,52,3,268-276
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the CLP Regulation (EC 1272/2008), in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.
A substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for subcategorisation (1A and 1B) in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).
If in order to evaluate skin sensitisation potential, a Guinea pig maximisation test was performed, a substance is classified as skin sensitizer sub-category 1B if ≥ 30 % responding at > 1 % intradermal induction dose.
Based on the experimental results, the substance induces no reactions after the intradermal induction dose > 1 %. Therefore, the substance is not classified as skin sensitiser, according to the CLP Regulation (EC 1272/2008).
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.
