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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 428-880-5 | CAS number: -
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:
In a guinea pig maximization test (Safepharm Laboratories Ltd, 1253/006, 1998), which was performed according to OECD guideline 406 and GLP requirements, young female Dunkin-Hartley guinea pigs (20 animals) were treated with the test substance, dissolved in distilled water. Intradermal injections were performed with 25% of the test substance and topical inductions were carried out with 50% one week after intradermal inductions. After the topical induction, a challenge was performed epicutaneously with 25 and 50% of the test substance (on the right and left flank of the animals) four 24 hours.Evaluation for sensitisation was performed 24 and 48 hours post termination of exposure: the test material produced a 0% (0/20) sensitisation rate. Only orange-coloured staining was noted at all challenge sites at the 24 and 48-hour observations.
Migrated from Short description of key information:
Guinea pig (GPMT): not sensitizing, OECD Guideline, GLP (Safepharm Laboratories Ltd, 1253/006, 1998). Only an incomplete study report is available and relevant data are missing. The reliability of the study is therefore restricted. However, with 20 animals, no skin reactions were noted 24 and 48 hours after challenge.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data available.
Migrated from Short description of key information:
No data available.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data are reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for sensitisation is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for sensitisation is not warranted under Regulation (EC) No.1272/2008.
No data are available to assess the respiratory sensitization potential of the test material.
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.
