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:

A read across approach was applied for skin sensitization using data of the similar sodium sulphooctadecanoate (CAS 67998-94-1). This substance is considered to show similar toxicological properties as compared to the test item as the only difference is the soium ion instead of a potassium ion.

The read across substance (CAS 67998-94-1) sodium sulphooctadecanoate was tested for its sensitization potential on the skin of guinea pigs using the maximization method (according to Magnusson, B. and Kligman, A.M.). In the test 36 guinea pigs from the strain Pirbright white were used (2x 3 animals for preexperiments, 20 substance animals and 10 control animals). During the preexperiments the maximal non-irritating dose was determined and the minimal irritating dose. The main test began with an intracutaneous and an epicutaneous application. After intracutaneous and epicutaneous (occlusively/48 h) application in doses of 0.3 % in NaCl and 60 % in Vaselin the retreatement was performed. During the first challenge the test item was applied occlusively for 24 h in a dose of 0.1 mL of a 40 % Vaseline solution. After this challenge 18 of 20 animals showed skin reactions after 24 hours. 16 of 20 animals showed skin reactions after 48 hours. These reactions were judged to be irritating reactions due to Vaseline. Also the control group showed reactions in 8 of 10 animals after 24 hours and in 6 of 10 animals after 48 hours. A second challenge was conducted with the same dose level but in NaCl. After 24 hours 4 of 20 animals showed skin sensitizing reactions. After 48 hours 2 of 20 animals showed skin sensitizing reactions. According to the test results obtained, the substance can be regarded as non-sensitizing for guinea-pigs.


Migrated from Short description of key information:
The read across substance (CAS 67998-94-1) sodium sulphooctadecanoate was tested for it´s sensitization potential on the skin of guinea pigs using the maximization method. After the second challenge the test substance showed in only 4 of 20 animals skin reactions after 24 hours and in only 2 of 20 animals after 48 hours. According to these results the substance can be considered to have no skin sensitizing potential.

Justification for selection of skin sensitisation endpoint:
Guideline and GLP study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is not considered to be classified for skin sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 1297/2014.