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 two guinea pig maximization studies available for evaluating the skin sensitization potential of sec-alkane sulfonate-sodium salts SAS tested at 60%. In the first study induction treatment included 10 intradermal injections of 5% sec-alkane sulfonate-sodium salts SAS in Freund`s complete adjuvant. Challenge treatment was performed using sec-alkane sulfonate-sodium salts SAS at the same test concentration. As a result no signs of skin sensitization were observed after the first challenge treatment. Also a second challenge treatment revealed no signs of skin reactions (sensitization incidence = 0%). In the second test, intradermal induction was carried out using a 0.05% solution of sec-alkane sulfonate-sodium salts SAS in Freund`s complete adjuvant and the dermal induction was performed using a 5% solution in water. Challenge treatment was performed 14 days later using a 1% aqueous sec-alkane sulfonate-sodium salts SAS solution. No skin reactions were observed. The sensitization incidence was 0%. Based on the available study results no skin sensitization potential was found for sec-alkane sulfonate-sodium salts SAS when tested in guinea pigs according to the protocol of Magnusson and Kligman.


Migrated from Short description of key information:
Sec-alkane sulfonate-sodium salts SAS was tested as 60% aqueous solution in two guinea pig maximization tests according to Magnusson and Kligman. Both tests were not conducted according to GLP but followed OECD 406 guideline criteria and are of acceptable validity for evaluation. In one study induction was carried out using 10 intradermal injections of a 0.5% aqueous solution of sec-alkane sulfonate-sodium salts SAS followed 14 days later by a challenge treatment using a 5% solution. In the second study intradermal induction was performed with a 0.05% aqueous solution in Freund`s complete adjuvant, dermal induction using a 5% solution and dermal challenge treatment with a 1% aqueous sec-alkane sulfonate-sodium salts SAS solution. No sensitization potential of sec-alkane sulfonate-sodium salts SAS was found in either test.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no experimental data concerning potential respiratory sensitization available. However, from data on human experience, occupational medical surveys and results from skin sensitization tests it is concluded that sec-alkane sulfonate-sodium salts SAS is not a respiratory sensitizer.


Migrated from Short description of key information:
There are no experimental data concerning potential respiratory sensitization available. However, from data on human experience, occupational medical surveys and results from skin sensitization tests it is concluded that sec-alkane sulfonate-sodium salts SAS is not a respiratory sensitizer.

Justification for classification or non-classification

There are two guinea pig maximisation studies available for sec-alkane sulfonate-sodium salts SAS. Both studies did not reveal any indications of a sensitization potential of sec-alkane sulfonate-sodium salts SAS. Based on the results of these studies sec-alkane sulfonate-sodium salts SAS is not subject for classification as skin sensitizer. Human experiences as well as occupational medical surveillance programs are supporting this conclusion.