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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
other: published data
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Assessment of the teratogenic potential of surfactants (Part I) – LAS, AS and CLD.
Author:
Palmer, A.K., Readshaw, M.A. and Neuff, A.M.
Year:
1975
Bibliographic source:
Toxicology 3:91-106.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Animals received doses by gavage daily from days 6-15 of gestation. Twenty animals per dose group were used.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
C12-LAS
IUPAC Name:
C12-LAS
Details on test material:
LAS (Na salt); average alkyl chain length = C11.7

Test animals

Species:
rat
Strain:
other: CD
Details on test animals or test system and environmental conditions:
Species/strain: Rat: CD,Sex: Female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
day 6 - 15 of pregnancy
Frequency of treatment:
daily
Duration of test:
sacrifice at day 20 of gestation
No. of animals per sex per dose:
Twenty animals per dose group were used.
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:
Body weight gain was retarded in the highest dose group from the start of dosing and showed partial recovery toward the end of the dosing period. One animal died in this group but it could not be conclusively related to treatment. The toxic effects were associated with disturbance of the gastrointestinal tract. Pregnancy rate was comparable at all dosages.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day
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:
No differences were observed among dose groups and the control group with respect to number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, pre- and post implantation embryonic loss, major malformations, minor visceral or embryonic loss, major malformations, minor visceral or skeletal anomalies or incidence of pups with extra ribs.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
600 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL Maternal Toxicity: 300 mg/kg bw
NOAEL teratogenicity: 600 mg/kg bw
Executive summary:

Twenty animals per dose group were used. Animals were daily administered at day 6-15 of pregnancy by gavage with LAS at doses of 0.2, 2, 300, 600 mg/kg bw/day and sacrificed at day 20 of gestation. A control group was used. The body weight gain was retarded in the highest dose group from the start of dosing and showed partial recovery toward the end of the dosing period. One animal died in this group, but it could not be conclusively related to treatment. The toxic effects were associated with disturbance of the gastrointestinal tract. Pregnancy rates were comparable at all dosage.

No differences were observed among the dose groups and the control group with respect to: number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, pre- and post-implantation embryonic loss, major malformations, and minor visceral or skeletal anomalies or incidence of pups with extra ribs.

NOAEL Maternal: 300 mg/kg bw/day

NOAEL teratogenicity: 600 mg/kg bw

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