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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
Administration comprised only period of organogenesis.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium laurylethersulfate
- Ethoxylation degree: No data
- Physical state: Colourless to yellowish paste
- Analytical purity: 70.1% a.i.
- Lot/batch No.: 198/3
- Storage condition of test material: At RT

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
no
Details on mating procedure:
According to Guideline.
Duration of treatment / exposure:
Day 6-15 (incl.) post coitum
Frequency of treatment:
Daily
Duration of test:
Until Day 20 p.c.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
24 females
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
According to Guideline.
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes

Examinations included: Gravid uterus weight, number of corpora lutea, implantations and early/late resorptions
Fetal examinations:
- External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No
Statistics:
Yes

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The results of this study showed that repeated oral administration (Day 6-15 post coitum) of the test substance to pregnant rats caused no symptoms of cumulative toxicity and does not reveal any embryotoxic or teratogenic potential up to a dose level of 1000 mg/kg body weight/day.