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

Carcinogenicity

Description of key information

Sec-alkane sulfonate-sodium salts SAS (as 60% aqueous solution) were tested for potential carcinogenic effects using the oral and dermal route of exposure. The studies were not conducted according to GLP but followed accepted scientific guidance at time of performance and are of acceptable quality for evaluation purposes. Reliability declarations from the study director are included in the report.

In a two-year bioassay in rats receiving up to 2% (w/w) of the test compound in the diet, both the non-neoplastic as well as neoplastic pathology were within normal limits. Based on the results, there was no indication of a carcinogenic potential of sec-alkane sulfonate-sodium salts SAS (tested as 60% aqueous solution) after oral administration for two years to rats.

Mice were treated dermally at concentrations up to 1% (w/w) sec-alkane sulfonate-sodium salts SAS (as 60% aqueous solution) over a scheduled period of 80 weeks followed by an observation period lasting 24 weeks. No signs of treatment related effects were recorded at any time during the total 104 week period. Histopathological examination of skin samples revealed also no treatment related abnormalities. There was no evidence to suggest that sec-alkane sulfonate-sodium salts SAS is carcinogenic under the conditions of the available study.

Justification for classification or non-classification

Potential carcinogenicity of sec-alkane sulfonate-sodium salts SAS was investigated in a 2-year feeding study in rats. Based on the results of this bioassay, no indications of non-neoplastic and/or neoplastic pathology have been revealed using dietary levels of up to 2% (w/w) corresponding to about 1000 mg/kg body weight per day. Likewise, using the dermal route of exposure no carcinogenic potential was revealed in a 104 week study in mice up 1% (w/v) in distilled water. Based on all available data no carcinogenic potential is attributable to sec-alkane sulfonate-sodium salts SAS and thus a classification with regard to this endpoint is not required.

Additional information

Sec-alkane sulfonate-sodium salts SAS (as 60% aqueous solution) was tested for potential carcinogenicity in rats. Initially a temporary impaired grooming in rats receiving the highest dietary concentration of 25 (w/w) was noted. No other finding was recorded in respect to appearance, general health condition, behaviour and locomotor function. Survival was not affected. The cellular and chemical characteristics of blood and urine were undisturbed by treatment. Macroscopy and histopathological investigations revealed no indications of non-neoplastic and/or neoplastic changes. The NOAEL was set at 2% (w/w) in the diet corresponding to about 1000 mg/kg body weight per day. In a dermal bioassay mice received up to 1% sec-alkane sulfonate-sodium salts SAS (as 60% aqueous solution) dermally over an experimental treatment period of 80 weeks followed by a 24 week observation period. Body weight gain, as well as food and water intake was unaffected. Findings from gross pathology were within normal limits. Histopathologically no indications of non-neoplastic and/or neoplastic changes were obtained. Based on the results, sec-alkane sulfonate-sodium salts SAS exhibits no carcinogenic properties after chronic dermal exposure in mice.