Sulfonic acids, C14-17-sec-alkane, sodium salts

Endpoint summary

Description of key information

Sec-alkane sulfonate-sodium salts SAS is not a skin irritant when tested according to OECD guideline 404. The test followed the principles of GLP and is regarded to be valid without restrictions. In the presence of water the chemical reactivity is increased and skin irritation reactions become apparent when aqueous dilutions of sec-alkane sulfonate-sodium salts SAS are tested. This view is supported by animal data with sec-alkane sulfonate-sodium salts SAS as 60% aqueous solution, showing moderate skin irritating properties in animals. However, well documented human volunteer studies performed under GCP conditions indicate that sec-alkane sulfonate-sodium salts SAS up to aqueous concentrations of 60% active matter is not a significant skin irritant in humans
With regard to eye irritation sec-alkane sulfonate-sodium salts SAS is considered to be eye irritating. Technical grade sec-alkane sulfonate-sodium salts SAS themselves were not tested. However, findings of all available studies conducted with aqueous sec-alkane sulfonate-sodium salts SAS solutions according to OECD 405 were consistent and demonstrated concentration dependent irritant effects. sec-alkane sulfonate-sodium salts  SAS is slightly irritating to eye at 15% but is irritating to eye at concentrations of 30% and above. However, when the low-volume technique is applied even a 30% aqueous solution of sec-alkane sulfonate-sodium salts SAS is not causing significant eye irritation. However, based on all available data sec-alkane sulfonate-sodium salts SAS is considered to be an eye irritant. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Several experimental animal studies according to GLP have consistently shown that technical grade sec-alkane sulfonate-sodium salts SAS (93%) is not exhibiting significant skin irritating properties. However, in contact with water an increased chemical reactivity is observed which may explain that sec-alkane sulfonate-sodium salts SAS when tested as 60% aqueous solution in rabbits demonstrated skin irritating properties. However, in a series of human volunteers studies no significant skin irritating properties were found even when sec-alkane sulfonate-sodium salts SAS was tested up to 60% in water. A human covered patch test according to GCP revealed only very slight but transient erythema reactions in some of the volunteers. Based hereupon, sec-alkane sulfonate-sodium salts SAS in aqueous concentrations up to 60% was not regarded to be a skin irritant in humans even under conditions comparable to animal experiments.

Four individual eye irritation studies on rabbits are available for sec-alkane sulfonate-sodium salts SAS at various aqueous concentrations of 15 up to 60 %. Findings of all studies were consistent and demonstrated concentration dependent irritant effects. sec-alkane sulfonate-sodium salts SAS as 30% aqueous solution was considered to be severely irritating to eyes whereas only slight irritating effects were observed when tested as 15% aqueous solution. However, testing of sec-alkane sulfonate-sodium salts SAS as a 30% aqueous solution for primary eye irritation using the low volume test procedure resulted in only slight irritative effects.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on all available data with regard to dermal irritation, technical grade sec-alkane sulfonate-sodium salts SAS (93%) is not considered to represent a significant skin irritant when tested in animals according to OECD guideline 404. This is also supported by a series of human volunteer studies which have not demonstrated significant skin irritating effects of sec-alkane sulfonate-sodium salts SAS in aqueous concentrations up to 60%. However, due to the observed increase in reactivity when in contact with water and based on the observed significant skin irritating effects at lower aqueous test concentrations in test animals, technical grade sec-alkane sulfonate-sodium salts SAS (93%) is classified as skin irritant taking the precautionary principle into account.

Based on the results obtained for a 30% aqueous solution of sec-alkane sulfonate-sodium salts SAS in an eye irritation study, sec-alkane sulfonate-sodium salts SAS (93%) is classified as an eye irritant. With regard to eye irritation, sec-alkane sulfonate-sodium salts SAS at aqueous concentrations of 30% and higher has to be classified as eye irritant. Aqueous concentrations of sec-alkane sulfonate sodium salts SAS of 15% and lower resulted in only slight irritating effects not triggering classification.