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:

Buehler method 1971 - An in vivo study was performed to assess the skin sensitisation potential of the test material in the Hartley strain guinea pigs following the buehler method. The study was performed pre-GLP and following a method similar to OECD Guideline 406. For the epicutaneous induction and challenge application, a concentration of 10% was used. A group of 11 test animals received induction doses by topical application. Prior to each application of the test material, the hair was close clipped from the inter-scapular region using electric clippers. The test material was applied, at a volume of 0. 1 ml on a half inch square of surgical gauze, to the clipped inter-scapular region of the guinea-pigs in each group. The gauze was covered with impervious adhesive tape. The dressings were left in place for 24 hours. The test animals were challenged two weeks after the epidermal induction application. None of the test animals exhibited a dermal reaction to the challenge application of the test materials. Based on these results, the test material is not considered to be a skin sensitizer in guinea pigs.

 

HRIPT 1979 - A human repeat insult patch test study was performed to assess the skin sensitiser potential of the test material in human volunteers. The study was performed following a modification of Draize Repeated Insult Patch Test method. The test substance was evaluated in 50 human volunteers. A dose of 0.2 g test substance, was applied to the upper arm of each subject under a semi-occlusive dressing for 24 hours. This was repeated 3 times a week for 3 weeks for a total of 9 applications. A 2 week rest period then elapsed after which a challenge application was applied in the same manner to the same skin sites as well as to previously untreated skin sites on the same arm. The challenge applications were removed after 24 hours and the two sets of test sites were examined for signs of irritation or sensitization. The sites were re-examined after 48 and 72 hours. No skin effects were observed in any test subject. Under the conditions of this test, the test material is not considered to be a skin sensitiser.

 


Migrated from Short description of key information:
not skin sensitising, Buehler method, Davies 1971
not skin sensitising, HRIPT, Wilson 1979

Justification for selection of skin sensitisation endpoint:
one in vivo klimisch 4 and one HRIPT klimisch 4 studies. No study was selected since all studies indicate with clear weight of evidence no adverse effects.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for skin sensitisation.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for skin sensitisation.