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 study was performed to the requirements of OECD Guideline 406 and EU Method B.6 in accordance with GLP to assess the skin sensitisation potential of the test material in Ibm: GOHI; SPF-quality female guinea pigs following the guinea pig maximisation method. The test was validated in a historic positive control group using alpha-hexylcinnamaldehyde positive control substance documented in the study report. In a pretest, the intradermal application concentration of 5% was selected for the main test as at this concentration only mild irritation was observed. For the epicutaneous induction and challenge application, a concentration of 100% was selected for the main test as no dermal reaction in any animal at any concentration was observed in the pretest. In the main study, a group of 15 test animals (10 test animals treated with test material, 5 animals serving as an irritation control) received induction doses by intradermal injection and topical application. The intradermal injections were made within the boundaries of a 4 -cm x 6 -cm area, one row of three injections on each side of the midline. Each animal received the following: 0.1 ml of a 1:1 dilution of Freund's Complete Adjuvant in physiological saline; 0.1ml of 5% test material; medial site: 0.1ml 5% test material in Freund's Complete Adjuvant in physiological saline. The control group received the vehicle instead of the test material. On Day 7 test animals backs were shaved and pretreated with a 10% w;w sodium lauryl sulfate (SLS) suspension in paraffinum perliquidum before the topical induction application. Undiluted test material was applied over the injection sites of the test animals. The patch was covered with aluminium foil and firmly secured by a elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for 48 hours. The test and control guinea pigs 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 or control materials. Based on these results, the test material is not considered to be a skin sensitiser in guinea pigs.


Migrated from Short description of key information:
Skin sensitisation: non-sensitising, female guinea pig, OECD 406 GPMT, RCC, Research and Consulting Ltd. 1999

Justification for selection of skin sensitisation endpoint:
One GLP compliant guideline (Klimisch 1) GPMT study available; selected study is an in vivo study indicating negative reaction to dermal exposure at 100%v/v challenge dose.

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

 

In the GPMT test the severity of effects were limited and in the range of the naive control group (erythema score less than 0.5). The effects were specifically less than erythema score 1 in all organisms. The test was validated by a historic positive control group which gave responses of score 1 to 2 at > 1% intradermal induction dose. Under EU criteria no significant effects were observed in the in vivo GPMT study on exposure to the substance at > 5% v/v intradermal induction dose. The substance cannot be considered a skin sensitiser.