Alcohols, C12-18, ethoxylated, sulfates, sodium salts

Developmental toxicity / teratogenicity

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

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

Test material information

Constituent 1

Reference substance name:

68891-38-3 (purity 70.1 %)

IUPAC Name:

68891-38-3 (purity 70.1 %)

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 or test system 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)

1

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: maternal toxicity

2

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.