Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

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

Na-LAS (chain length distribution C_10-14) was fed for 84 days to 4 groups of weanling rats (3 dose levels, plus control), each dose consisting of 50 animals each of both sexes (P_O-generation). When the P₀generation was 107-112 days old, 20 females from each dose group were mated with 20 males from the same group and maintained together for 17 days. The first litters of each generation (F_la- and F_2a-generation) were sacrificed at 21 days of age. Ten days after the final litter was sacrificed, all females were remated with different males from the same group to obtain the F_1bgeneration. From the F_lb-generation, 20 males and females of each group were selected at weaning to continue their respective diets and to be used for further reproduction studies. Reproduction studies on the F_1band F_2bgenerations were started when the rats were 80 to 85 days old, and were continued until the F_3bgeneration was weaned.

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/day.

Short description of key information:
No fertility studies are reported for the reaction product Marlon ARL. However, the 3-generation reproduction study with the major constituent of the Marlon ARL (i.e., the read across linear alkylbenzenesulfonate) and the 90-day oral rat and oral mouse studies and the 2-year chronic dermal rat and mouse studies with the other major constituent of Marlon ARL (i.e., the read across sodium xylene sulfonate) that included examination of sex organs of both sexes reported no treatment related effects on parents or offspring. No fertility effects were observed in the 3-generation study with linear alkylbenzenesulphonate at the highest exposure concentration of 350 mg/kg bw/day. Given the relatively low toxicity of the constituent substances of the reaction product Marlon ARL, the reported evaluation of reproductive endpoints for the constituent read across substances, and also because of animal welfare, a reproductive study with the substance to register (Marlon ARL) is not recommended.

Effects on developmental toxicity

Description of key information

Female rats were given linear alkylbenzenesulfonate (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 including size, weight and fetal loss 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 - 600 mg/kg bw/day.  The NOAEL for both maternal toxicity and teratogenicity is 300 mg/kg bw/day.
A single developmental toxicity study is reported for calcium xylene sulphonate (CAS No. 28088-63-3) which is closely related to the other compounds in the hydrotropes category. The 1994 developmental study did not follow a specific guideline but was fully documented and conducted in accordance with GLP requirements.  No adverse effects were reported.  The NOAEL for both maternal and foetal toxicity was the highest dose tested - 3000 mg/kg bw /day which is equivalent to 936 mg active ingredient per kilogram body weight per day.  The conclusion of the study was no indications of developmental toxicity including teratogenesis.  

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

300 mg/kg bw/day

Additional information

The 90-day oral rat and oral mouse studies and the 2-year chronic dermal rat and mouse studies with the closely related hydrotrope compound sodium xylene sulfonate (CAS No. 1300-72-7) included examination of sex organs of both sexes. No treatment related effects on reproductive organs were reported at doses roughly equivalent to those in the developmental toxicity study.

Justification for classification or non-classification

No classification as a repeated dose toxin is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.