Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 406, EU Method B6 and EPA OPPTS 870.2600 (Guinea pig maximisation test), in compliance with GLP. The study design was based on the preliminary test results. In the main study, 10 female Guinea pigs were intradermally injected with a 1% concentration and epidermally (occlusive) exposed to a 2% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Two weeks after the epidermal application all animals were epidermally challenged with a 2% test substance concentration and the vehicle. In the challenge phase, no skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 2% test substance concentration in the challenge phase. This result indicated a sensitization rate of 0 per cent. No skin irritation were observed in the control group. No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. Under the study conditions, the test substance did not induce skin sensitisation in Guinea pigs (Latour, 2016).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of Guinea pig maximisation test, the substance does not require classification for skin sensitization according to CLP (Regulation 1272/2008) criteria.