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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 421-820-9 | CAS number: 192268-65-8 CD 28-0132; IRGALUBE 232
Endpoint summary
Administrative data
Description of key information
No animal not produce evidence of skin sensitisation (delayed contact hypersensitivity) in the key study. Based on the evaluation criteria of Annex VI of the Commission Directive 67/548/EEC, the evaluation "sensitizing" is warranted when at least 30 % of the test animals exhibit positive skin reactions in the adjuvant test. Therefore the test article is not sensitizing at skin contact.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a dermal sensitization study performed according to the EU Method B.6 (Skin Sensitisation) 92/69/EWG, 4-5 weeks old guinea pigs were used to test for contact sensitization of the test article. The control group consisted of 5 animals and the test group was composed of 10 animals. Intradermal inductions were performed with 1% of the test article in Alembicol D mixed with Freund's complete adjuvant (FCA). 7 days later, topical inductions were carried out under occlusive conditions for 48 hours with the undiluted test article. Following a 2 week treatment free interval, challenge exposures were performed epicutaneously (occlusive, 24 hours) with the undiluted test article in Alembicol D. Evaluation of the skin reactions was performed 24 and 48 hours after challenge exposures. No animal showed a positive reaction in the treatment as well as the control group. Assays with the positive control substance (hexyl cinnamic aldehyde (CAS No. 101-86-0)) performed regularly in the same laboratory caused the expected reaction (Huntingdon Life Sciences Ltd. 1995).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation 1272/2008. Based on the criteria laid down in Regulation (EC) No. 1272/2008, classification as a skin sensitizer is not warranted.
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.
