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Description of key information

Sec-alkane sulfonate-sodium salts SAS as 60% aqueous solution was  tested for systemic toxicity using both, the oral and dermal route of exposure. All available tests are no guideline studies and non-GLP but performed according to scientific standards at time of performance and of acceptable validity based on nowadays standards. 
Reliability declarations regarding procedures and performance are available. The studies are well performed and documented. Based on the results of a chronic oral toxicity study with 60% aqueous solution of sec-alkane sulfonate-sodium salts SAS in rats, a NOEL of 200 mg/kg body weight per day is used for risk assessment purposes, although no significant changes have been reported even at dietary levels of up to 2% (w/w) corresponding to about 1000 mg/kg body weight per day which is regarded to be a NOAEL..
A subacute dermal toxicity study in mice, performed with a 60% aqueous solution of sec-alkane sulfonate-sodium salts SAS revealed no indications of toxicity after dermal treatment at 8% (w/v) for 4 or 5 consecutive weeks. Based on the results of this test, the NOEL for local effects was calculated with approximately 500 mg / kg body per day. At higher test concentrations signs of irritation / inflammation at the treated skin sites were revealed. Systemic toxic effects were not observed. Inhalation studies with repeated exposure are not available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
chronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
mouse

Additional information

In a feeding study, rats received sec-alkane sulfonate-sodium salts SAS (tested as 60% aqueous solution) for a period of 52 weeks in concentrations up to 2% via the diet. The only detectable effect was impaired grooming activity and retarded weight gain which was related in part to reduced food consumption. These non-specific changes were not accompanied by any significant functional and/or structural changes as demonstrated by pathology. Based on the study results the NOEL was conservatively placed at 0.4% (w/w) sec-alkane sulfonate-sodium salts SAS which approximates 200 mg/kg body weight per day. However, even at the highest level of 2% (approximately 1000 mg/kg body weight per day) in the diet only unspecific changes were noted.

Aqueous solutions of a 60% aqueous formulation of sec-alkane sulfonate-sodium salts SAS were administered to the intact skin of groups of 25 female mice at concentrations of 0, 0.1, 0.5 (increasing to 8.0 and finally to 16.0) and 1.0 (increasing to 2.0 and finally 32.0) % w/v over periods of four or five weeks. A constant dose of 0.1 mL / mouse was used on five days per week of treatment. Encrustation, skin thickening, erythema and slight sloughing were observed at the treated site in all mice administered 32 % w/v. Mice given 16% showed slight skin thickening after one week of treatment. Weight loss, without concomitant reduction of food intake, was seen in all mice receiving 32%. There was a return to normal growth during the second week at this dose level. Necropsy findings were confined to the application site and consisted of skin thickening, erythema, oedema, sloughing and pus at 32%, and skin thickening at 16%. Mice treated with solutions containing 8% w/v and below were unaffected by treatment.Inhalation studies with repeated exposure are not available.


Repeated dose toxicity: dermal - systemic effects (target organ) other: skin

Justification for classification or non-classification

Chronic oral administration of a 60% aqueous solution of sec-alkane sulfonate-sodium salts SAS to mice revealed no significant morphological and/or functional changes. Repeated dermal administration of a 60% aqueous solution of sec-alkane sulfonate-sodium salts SAS to mice resulted in local skin irritating effects. Substance related systemic toxicity was not observed. Based on the results of all available studies a classification of sec-alkane sulfonate-sodium salts SAS with regard to systemic toxic effects is not deducible.