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Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Reference Type:
review article or handbook
Title:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts.
Author:
European Commission.
Year:
2000
Bibliographic source:
Year 2000 CD-ROM edition

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: LAS was injected at doses of 20 mL/kg/day from day 0 to 3 or day 8 to 11 of pregnancy. There were 12 - 19 mice in each treatment group.
GLP compliance:
not specified
Type of method:
in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
EC Number:
270-115-0
EC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
Cas Number:
68411-30-3
IUPAC Name:
sodium 4-undecylbenzenesulfonate
Details on test material:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts.
LAS, activity: 99.5%

Test animals

Species:
mouse
Strain:
ICR
Sex:
female
Details on test animals or test system and environmental conditions:
Species/strain: mouse/ICR Sex: Female

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
water
Details on exposure:
Subcutaneous injection,Doses: 0.35, 1% in water (20, 200 mg/kg bw d).
LAS was injected at doses of 20 mL/kg/day from day 0 to 3 or day 8 to 11 of pregnancy. There were 12 - 19 mice in each treatment group.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Day 0 to 3 or day 8 to 11 of pregnancy
Frequency of treatment:
daily
Duration of test:
Day 0 to 3 or day 8 to 11 of pregnancy
Doses / concentrations
Remarks:
Doses / Concentrations:
0.35, 1% in water (20, 200 mg/kg bw d)
Basis:
nominal conc.
No. of animals per sex per dose:
12 - 19 mice in each treatment group.
Control animals:
yes, concurrent no treatment
Details on study design:
LAS was injected at doses of 20 mL/kg/day from day 0 to 3 or day 8 to 11 of pregnancy.

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Remarks:
Maternal
Effect level:
20 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
other: NOAEL Maternal: 0.35% (20 mg/kg bw d)
Dose descriptor:
NOAEL
Remarks:
teratogenicity
Effect level:
200 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
other: NOAEL teratogenicity : 1% (200 mg/kg bw d)

Observed effects

When dams were administered the 1% solution from day 0 to 3 of pregnancy, there was an initial decrease in body weight and necrosis at the injection sites. The number of pregnancies decreased in the mice given the 1% solution compared to the controls (61.5% vs. 93.3%) There were no significant changes with respect to litter parameters, major malformations or minor abnormalities.

Applicant's summary and conclusion

Conclusions:
NOAEL Maternal: 0.35% (20 mg/kg bw d)
NOAEL teratogenicity : 1% (200 mg/kg bw d)
When dams were administered the 1% solution from day 0 to 3 of pregnancy, there was an initial decrease in body weight and necrosis at the injection sites. The number of pregnancies decreased in the mice given the 1% solution compared to the controls (61.5% vs. 93.3%) There were no significant changes with respect to litter parameters, major malformations or minor abnormalities.