Calcium dodecylbenzenesulphonate

Toxicity to reproduction: other studies

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

Justification for type of information:

The study was evaluated by IPCS prior to inclusion in their criteria document

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Teratogenicity of some synthetic detergents and linear alkylbenzene sulfonate (LAS) Ann.

Author:

Takahashi, M., Sato, K., Ando, H., Kubo, Y. and Hiraga, K.

Year:

1975

Bibliographic source:

Rep. Tokyo Metrop. Res. Lab. Public Health 26:67-78 (inJapanese); cited in: IPCS (1996); Environmental Health Criteria 169: Linear Alkylbenzene Sulfonates (LAS) and Related Compounds. WHO, Geneva, Switzerland.

Reference 2

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

Test material information

Constituent 1

Reference substance name:

C12 LAS

IUPAC Name:

C12 LAS

Test material form:

solid: compact

Details on test material:

- Name of test material (as cited in study report):C12 LAS homologue; C10 LAS homologue

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

1

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)

2

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.