Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

350 mg/kg bw/day

Study duration:

chronic

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

A three generation, two year reproductive study is available for LAS. LAS were 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%)

Short description of key information:

The NOAEL from a three generation, two year reproductive study in rats was 350 mg/kg bw. No significant effects were observed at this highest dose tested.

Justification for selection of Effect on fertility via oral route:

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

Description of key information

Two developmental studies are available.  No significant effects were observed in the offspring in the absence of maternal toxicity. Both studies resulted in a NOAEL of 300 mg/kg bw/day.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

300 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Two developmental studies are available. In the first, female rats were given Na-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. Pregnancy rates were comparable at all doses. 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/day 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). 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 and 300 mg/kg bw 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.

Justification for selection of Effect on developmental toxicity: via oral route:

Two developmental studies are available.  No significant effects were observed in the offspring in the absence of maternal toxicity. Both studies resulted in a NOAEL of 300 mg/kg bw/day.

Justification for classification or non-classification

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