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:

There are four study reports available investigating the skin sensitising abilities of Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts.

The first key study was performed according to the method of Magnusson and Kligman (Guinea Pig Maximisation Test) and was chosen as an example for an adjuvant test (Sugar & James, 1980). Although performed before the actual guideline was established, this study included a range finder test to determine the lowest irritant and the highest non-irritating concentration for induction and challenge, respectively, and is in accordance with the actual OECD guideline 406. Although only 10 animals were included in the test group, those animals were even treated with the neat test substance and a 1:1 preparation of the test substance in Complete Freund's Adjuvant for induction, and with 25% and 12.5% test substance concentrations for challenge. Both non-irritating concentrations from the range-finder were included in the challenge on respective flanks to ensure that at least one non-irritant concentration was used. Furthermore, this study included a negative control group. At first and second reading 24 and 48 hours after challenge, none of the animals demonstrated a positive response, neither with 25% nor with 12.5% challenge concentrations.

 

The same result is demonstrated by the second key study which was performed in guinea pigs without adjuvant by the Closed Patch Technique (Thompson, 1981). This method is comparable to the Buehler method described in the OECD guideline 406, but under even more stringent conditions. Therefore, this study was chosen as second key study as an example for a non-adjuvant test. Although in this test only 10 animals were included in the test group, they were treated 9 times with a remarkably high test substance concentration of 50% (w/v) for induction, followed by a challenge with 50% (w/v) test substance. At first and second reading 24 and 48 hours after challenge, only 1/10 animals demonstrated a positive response (10%) which does not exceed the threshold level of 15% demanded by the OECD guideline for non-adjuvant tests to consider a test substance as sensitising.

 

The aforementioned findings are further reflected by the other available study reports, which were performed with lower test substance concentrations in the Guinea Pig Maximisation Test (Chibanguza, 1987; Nicholas, 1975), and by a review article by Ter Haar (1983a), where the testing of 9 different commercial grade Alpha Olefin Sulfonate samples is described. The samples were tested in groups of 12 to 15 guinea pigs according to the method of Magnusson and Kligman (GPMT) (Ter Haar, 1983a). Only 2/9 samples induced a positive reaction in 1/15 and 1/13 animals, respectively. None of these samples exceeded the threshold level of 30% positive reactions for adjuvant studies.

 

In conclusion, the test substance did not show skin-sensitising effects either in adjuvant or in non-adjuvant studies.

Migrated from Short description of key information:

GPMT (OECD 406): not sensitising

Closed patch 9-times induction (comparable OECD 406 Buehler): not sensitising

Justification for selection of skin sensitisation endpoint:

The key study with the highest regulatory significance was used for the hazard assessment.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for the registered substance, Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts does not meet the criteria to be classified for skin sensitisation according to EU Directive 67/548/EEC and Regulation (EC) No 1272/2008.

 

No data are available for the assessment of respiratory sensitisation.