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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-460-0 | CAS number: 1471311-26-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a key study performed to OECD Guideline 406, a test group of 6 male and 6 female Hartley albino guinea pigs was dosed topically with the test material (100%) one time per week for three weeks for a total of three induction exposures. The duration of the exposures was 6 hours. Two weeks after the last induction exposure Test group animals were challenge dosed for detection of sensitisation by topical application of a known non-irritating concentration of the test material (50% in acetone) to previously unexposed areas of the skin. One week after challenge dosing, the Test Group animals were rechallenged to confirm the initial challenge results.
There were no deaths, clinical findings or remarkable body weight changes.
The positive control material, dinitrochlorobenzene, was demonstrated to be an extreme sensitizing agent in albino guinea pigs under the conditions of this study based on the Sensitization Incidence Index of 83%, thereby demonstrating the reliability of the test system.
There was one reaction in the Test Group that exceeded the highest reaction in the Naive Control Group I, following dosing with 50% w/v concentration of the test material in acetone. The Sensitization Incidence Index was calculated to be 8% for the Test Group following challenge dosing. There were two sensitization reactions (2/12) in the Test Group following rechallenge dosing with a 50% w/v concentration of the test material in acetone.
The Sensitization Incidence Index was calculated to be 17% for the Test Group following rechallenge dosing.
In accordance with CLP Regulation (EC) No 1272/2008 the test material is classified for skin sensitisation
Migrated from Short description of key information:
After rechallenge with 50% test material in acetone 2/12 animals showed a sensitisation reaction (17% sensisation). The substance is a skin sensitiser.
Justification for classification or non-classification
The skin Sensitization Incidence Index was calculated to be 17% for the Test Group following rechallenge dosing.
In accordance with CLP Regulation (EC) No 1272/2008 the test material is classified for skin sensitisation
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.
