Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

350 mg/kg bw/day

Additional information

A three generation reproductive study is available for the source analogue substance LAS. LAS was fed for 84 days to 4 groups of weanling rats for two years. No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw (0.5%).

Effects on developmental toxicity

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

300 mg/kg bw/day

Additional information

Two developmental studies are available. In a developmental study, female rats were given LAS orally in distilled water from gestation days 6 to 15 during pregnancy. Some effects such as decreased weight gain and transient diarrhea occurred at the highest dose, but pregnancy rates were comparable at all doses and litter parameters were not significantly affected at any dose. No significant differences were observed in visceral anomalies or skeletal variants, with the exception of a marginal retardation of sternabral ossification at the highest dose. The resultant NOAEL was 300 mg/kg bw/d for both maternal toxicity and teratogenicity. In a second developmental study, pregnant female mice were exposed to LAS via gavage on days 6 -15 of gestation. Increased mortality was observed at the two highest doses (300 and 600 mg/kg bw/day) but not at the next lowest dose (2 mg/kg bw/d). These doses also exhibited retarded weight gain and adverse signs in the necropsy. Pregnancy was comparable, however, for all groups. At doses without maternal toxicity, no differences were observed in any parameters. Because of the very wide range between the 2 mg/kg and 300 mg/kg doses, the maternal NOAEL of 2 mg/kg bw/day must be considered very conservative. The NOAEL for teratogenicity was 300 mg/kg bw/day.

Based on these combined results the NOAEL used for assessment is 300 mg/kg bw/d.

Justification for classification or non-classification

A series of reproductive and developmental toxicity studies are available on the analogue substance sodium salt of LAS. The resultant reproductive toxicity NOAEL was 350 mg/kg bw/d and the resultant developmental toxicity NOAEL based on two studies was 300 mg/kg bw/d. Based on the overall lack of significant developmental or reproductive toxicity at doses that were not maternally toxic in the analogue substance, it is expected that CaDDBS will have a similar profile and therefore would not need to be classified.