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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
day 6 to day 15 of pregnancy
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Acceptable, well-documented publication/study report which meets basic scientific principles.

Data source

Reference Type:

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
After overnight mating, the rats were randomly allocated to five groups which included one control group and four different treatment groups. LAS was prepared daily as a series of graded aqueous solutions. Animals in all groups were dosed orally at the standard volume of 1.0 mL/100 g. Control animals were dosed in a similar manner with distilled water used as the vehicle. The dams were observed daily for signs of toxicity and weighed on days 1, 3, 6, 10, 14, 17 and 20 of pregnancy. On day 20, the rats were killed by CO2 euthanasia. Their ovaries and uterine contents were examined immediately for number of copora lutea, number of viable young, number of resorption sites, litter weight, and fetal abnormalities.
GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
EC Number:
EC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
Cas Number:
sodium 4-undecylbenzenesulfonate
Details on test material:
LAS (Na salt) as a slurry containing 64.0% w/v of active ingredient (Lion Oil and Fat Co., Ltd.); average alkyl chain length (based on LAS SIDS Consortium Survey, 2002) = C11.7-12.3.

Test animals

other: Charles River CD strain

Administration / exposure

Route of administration:
other: oral in distilled water
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
day 6 to day 15 of pregnancy
Frequency of treatment:
Duration of test:
20 days
Doses / concentrations
Doses / Concentrations:
0.2, 2.0, 300 and 600 mg/kg
no data
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Parent animals were observed daily. Change in bodyweight was not affected by treatment at 0.2, 2.0, and 300 mg/kg, but treatment at 600 mg/kg was associated with retarded weight gain and a transient diarrhea following initiation of treatment. The pregnancy rate was comparable at all dosages.

Effect levels (maternal animals)

Dose descriptor:
Effect level:
300 other: mg/kg
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Embryonic and fetal development were assessed by the incidence of major malformations. The incidence of minor visceral anomalies was unaffected by treatment at any dosage. The distribution of skeletal variants were not statistically significant with the exception of a marginal retardation of sternebral ossification at 600 mg/kg.

Effect levels (fetuses)

Dose descriptor:
Effect level:
300 other: mg/kg
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Pregnancy/litter data: The litter parameters assessed included litter size, fetal loss and litter weight.  These parameters were not significantly affected by any dosage.  Mean pup weights were statistically higher at 0.2, 2.0 and 300 mg/kg.

Applicant's summary and conclusion

NOAEL = 300 mg/kg for both maternal and teratogenicity
Executive summary:

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. 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.