Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitization

The test substance was tested in a Guinea Pig Maximization Test according to EU method B.6 and OECD guideline no. 406. The test substance concentrations selected for the main study were based on the results of preliminary skin irritation tests.

In the main study, 20 animals were intradermally induced with a test substance concentration of 5% in propylene glycol. One week later the test substance in its pure form (100%) was applied epicutaneously on rabbit’s skin. After 48 hours, the test substance was removed with physiological saline. Ten control animals were similarly treated, but with vehicle only. Three to four weeks after the epicutaneous application all animals were challenged with the test substance in its pure form (100%). The second challenge was performed with 50% and 5% of the test substance. Vehicle was used as control.

After the first challenge 63 % of the treated animals showed signs of skin reactions (redness). The skin of the control animals was unaffected. After the second challenge skin reactions were noted in 63 % and 50 % of the animals treated with 50% and 5 %, respectively. No skin irritation was observed in control animals.

Body weight was reduced in animals of the treatment group and of control animals after challenge with the test substance compared to control group indicating a slightly systemic effect.

Under the conditions of the experiment, the test substance is considered to have a skin sensitising potential.


Migrated from Short description of key information:
Under the conditions investigated the test substance showed a sensitizing potential to skin.

Justification for selection of skin sensitisation endpoint:
Most reliable study (GLP and guideline study)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the presented study, the test substance was classified and labelled R43 (may cause sensitisation by skin contact) and skin sensitisation cat. 1B, H317 (may cause an allergic skin reaction) according to Directive 67/548/EEC (DSD) and to Regulation (EC) No 1272/2008 (CLP), respectively.