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:

Skin sensitisation

In the available CIBA-Geigy study (No. 874136, 1987) the skin sensitisation property of the test substance was determined using the Maximisation Test in the guinea pig. The study was conducted according to the OECD-Guideline 406 (adopted:1981). 20 guinea pigs (Pirbright White Strain (Tif: DHP), 10 male and 10 female) were induced first by three pairs of intradermal injections (0.1 ml per injection into the shaved neck of the guinea pigs as follows: - adjuvant and saline (1:1), - test compound in sesame oil, - test compound in the adjuvant saline mixture; concentration of test compound in sesame oil and adjuvant mixture: 1 %). One week later the test substance was incorporated in vaseline (0.4 g paste of 30 % test substance) and applied on a filterpaper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours). The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application). A control group was treated with adjuvant and the vehicle during the induction period. The challenge was conducted two weeks after the epidermal induction application. The animals were treated with the test substance in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours, 0.2 g paste of 10 % test substance in vaseline) on seperate flanks. Challenge reactions were assessed according to the Draize scoring scale 24 and 48 hours after removal of the dressings. The sensitivity and reliability of the experimental technique was ascertained in the lab every 6 month using Paraphenylene-diamine or Potassium-dichromate. Results were not given in the report. Under the experimental conditions employed, none of the animals of the test and the control groups showed skin reactions 24 and 48 hours after removal of the dressings.

The results of the acute skin sensitisation property of the test substance were supported by the findings of the study performed by CIBA-Geigy (No.821703, 1983), conducted similar to the OECD guideline 406 using the Maximisation Test in the guinea pig.


Migrated from Short description of key information:
In the CIBA-Geigy study (NO. 874136, 1987) the skin sensitisation in the guinea pig was examined according to the OECD guideline 406. The test substance is considered not sensitising after skin contact.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
no data available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. 

Based on the data, classification for skin sensitisation is not warranted.

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

The available experimental test data is reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.

Based on the data, classification for skin sensitisation is not warranted under Regulation (EC) No.1272/2008.