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

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles.

Data source

Reference

Reference Type:

other:

Title:

Unnamed

Year:

1971

Materials and methods

Test guideline

Qualifier:

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:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

LAS (average alkyl chain length = C11.7-12.3)

IUPAC Name:

LAS (average alkyl chain length = C11.7-12.3)

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

Species:

rat

Strain:

other: Charles River CD strain

Administration / exposure

Route of administration:

other: oral in distilled water

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

day 6 to day 15 of pregnancy

Frequency of treatment:

daily

Duration of test:

20 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0.2, 2.0, 300 and 600 mg/kg
Basis:
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:

NOAEL

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:

NOAEL

Effect level:

300 other: mg/L

Based on:

test mat.

Basis for effect level:

other: teratogenicity

Fetal abnormalities

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

Conclusions:

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.