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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
500 mg/kg bw/day
Additional information

The influence of sec-alkane sulfonate-sodium salts SAS (tested as 60% aqueous solution) upon reproductive function and fertility was assessed over two generations in rats. The test compound was administered in the diet to both the F0 and F1 generations at levels up to 10000 ppm. Treatment was given either continuously to both sexes for 60 days prior to mating and throughout three successive pregnancies (F1A, F1B, F1C, F2A, F2B and F2C) or to females only during the organogenesis stage of three successive pregnancies. Food intake, haematological parameters, absolute and relative organ weights as well as histopathological evaluation of tissues showed no adverse treatment-related effects. In the F0 generation, a slight but not statistical significant depression of body weight gain was observed. During the three subsequent pregnancies, some fluctuation in body weight gain was recorded in treated females, but no significant inter-group variation was observed. In both generations, oestrous cycles, mating performance and conception rates were unaffected by treatment. Macroscopic examination, absolute and relative organ weights and histopathological evaluation of F0 and F1 parent animals showed no adverse treatment-related effects. It was concluded from these investigations that continuous treatment with sec-alkane sulfonate-sodium salts SAS (as 60% aqueous solution) at a level of 10000 ppm was indicative of only slight, unspecific maternal toxicity.


Short description of key information:
The influence of sec-alkane sulfonate-sodium salts SAS (tested as 60% aqueous solution) upon reproductive function and fertility was assessed in a dietary study over two generations in rats. This 2-generation study included a segment II phase for developmental toxicity. The study was not conducted according to GLP but followed accepted scientific standards and is of acceptable quality for evaluation purposes. A reliability declaration from the study director is included in the report. Based on the results of this study depression of body weight gain indicative of unspecific maternal toxicity was observed at higher doses. Macroscopic examinations, absolute and relative organ weights and histopathological evaluations showed no adverse treatment-related effects. The NOAEL for maternal toxicity as well as fertility was placed at 10000 ppm in the diet corresponding to about 500 mg/kg body weight per day.

Effects on developmental toxicity

Description of key information

The influence of sec-alkane sulfonate-sodium salts SAS (tested as 60 % aqueous solution) upon reproductive function and fertility was assessed in a dietary study over two generations in rats. This study included a segment II phase for developmental toxicity. Female rats were administered the test compound during the organogenesis stage for three successive pregnancies up to a dose level of 10,000 ppm. No treatment-related effects and no signs of foetotoxicity were observed in any of the dose groups throughout the study. Teratogenic effects were neither observed. The NOAEL with regard to developmental effects was considered to be 10,000 ppm in the diet corresponding to about 500 mg/kg body weight per day.

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
500 mg/kg bw/day
Additional information

Sec-alkane sulfonate-sodium salts SAS(tested as 60% aqueous solution) was tested for reproductive function and intra-uterine development in rats by either continuous treatment to both sexes for 60 days prior to mating and throughout three successive pregnancies (F1A, F1B, F1C, F2A, F2B and F2C) or to females only during the organogenesis stage of three successive pregnancies. The animals received the test material at dose levels of 1000, 3000 or 10000 ppm in the diet. No treatment-related adverse effects were observed in any of the groups treated during organogenesis. There were no indications for an embryotoxic or teratogenic effect related to treatment in any dose groups.

Justification for classification or non-classification

Based on the results of the available expanded two-generation study including segment II testing, no indications of significant reproductive toxicity were observed. Indications for embryotoxic and/or teratogenic properties were not revealed. Accordingly, no classification of sec-alkane sulfonate-sodium salts SAS with regard to the endpoint reproductive toxicity is deducible.