Registration Dossier

Administrative data

Description of key information

The test substance was found to be a skin sensitizer under different experimental conditions. When present in polyol packages at 2%, no sensitization was observed in a guinea pig maximization study.

Key value for chemical safety assessment

Skin sensitisation

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

Several studies are available addressing the test article's potential to cause sensitization after skin contact. In the key study, the test substance was investigated in a Maximization test according to OECD guideline 406 (Ciba-Geigy, 1988). Pirbright White guinea pigs received three pairs of intradermal injections (0.1 ml per injection) into the shaved neck as follows: adjuvant and saline (1:1), test compound in sesame oil (1%), test compound in the adjuvant saline mixture (1%). One week later the test compound was incorporated in vaseline (30%) and applied on a filter paper patch to the neck of the animals occlusively for 48 hours. A control group was treated with adjuvant and the vehicle during the induction period. Epidermal challenge was performed by occlusive application for 24 h two weeks later (10% in vaseline). The control group was treated with the vehicle as well as with the neat test compound (at least 10 animals) to control the maximum subirritant concentration of the test article in adjuvant treated animals. Twenty-four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. 70% of the animals were sensitized by the test compound under the experimental conditions employed. According to the maximization grading the test compound showed a strong grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.

Similar positive results were reported in a supporting maximization test (Ciba-Geigy, 1982), and in an additional optimization tests (Ciba-Geigy, 1982). In all studies, significant differences between control animals and test animals were reported. The test item is therefore considered to possess skin-sensitizing (contact allergenic) potency in albino guinea-pigs and requires classification.

When present in polyol packages at 2%, no sensitization was observed in a guinea pig maximization study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for sensitization (Skin Sens Cat. 1A) is warranted under Regulation (EC) No.1272/2008.