Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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 dermal sensitization study (RCC 1996, 635027, Val.1), which was performed according to OECD guideline 406/EU method B.6, female Himalayan guinea pigs (20 animals) were treated with the test substance dissolved in polyethylene glycol. Intradermal injections were performed with 5% of the test substance and topical inductions were carried out with 100% under occlusive conditions one week after intradermal inductions. 2 weeks after topical induction, challenge was performed epicutaneously for 24 hours (occlusive, 100% of the test substance). Evaluation for sensitisation was performed 24 and 48 hours post termination of exposure. None of the animals showed erythema or edema after 24 resp. after 48 hours.

In conclusion, the test substance was found to be a non-sensitizer when tested in the Maximization-Test in accordance with OECD Guideline No. 406.



Migrated from Short description of key information:
Guinea pig (GPMT): not sensitizing (RCC, 635027 1996, Val.1)

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 studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011)