Registration Dossier

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:

The aim of the study was to investigate the sensitising potential of the test item using a traditional sensitising test with guinea pig. The study was performed according to the OECD 406, adopted in 1989. 10 females and 5 females were used as treatment and negative control group, respectively. For the first induction the test item was administered epicutaneously following the injection of Freund's complete adjuvant. Before the second induction exposure, the animals were pre-treated with n-dodecylsulfate, sodium salt (10 % in white petrolatum (w/w)). The second induction followed epicutanously on day 8 using a test item concentration of 50 % (w/w) in white petrolatum. At day 23 the epicutanous challenge was performed again with 50 % (w/w) in white petrolatum. Test sites were covered with occlusive dressings. The results of skin examinations were decisive for the grading of the potential of sensitisation. No positive skin reactions were observed after 24 hours and 48 hours. The test item is considered to be "non-sensitising" by skin contact.


Migrated from Short description of key information:
The test item was tested for skin sensitisation in a GLP study according to OECD 406 in guinea pigs. The test item is considered to be "non-sensitising" by skin contact.

Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data on sensitisation the test item is not subjected to classification and labelling according to Regulation 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).