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Developmental toxicity / teratogenicity

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developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Data source

Reference Type:
study report

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Partially natural parturition.
GLP compliance:

Test material

Constituent 1
Reference substance name:
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
EC Number:
EC Name:
Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
Cas Number:
Molecular formula:
Sulfuric acid, C12-14-alkyl (even numbered) esters, sodium salts
Details on test material:
- Name of test material (as cited in study report): trade name- Physical state: No data- Analytical purity: 100%- Lot/batch No.: No data- Storage condition of test material: No data

Test animals

Details on test animals or test system and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Details on exposure:
Concentration in vehicle: 10%
Analytical verification of doses or concentrations:
Details on mating procedure:
According to Guideline.
Duration of treatment / exposure:
Day 6-15 of gestation.
Frequency of treatment:
Once daily.
Duration of test:
Day 21 and Post parturition, resp.
No. of animals per sex per dose:
20 females (15 for dissection; 5 for natural parturition)
Control animals:
yes, concurrent vehicle


Maternal examinations:
Acording to Guideline, except for parturition. Except of killing one day prior to the expected day of delivery, five of 20 dams were allotted to natural parturition before sacrifice.
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: YesExaminations included:- Gravid uterus weight: Yes - Number of corpora lutea: Yes - Number of implantations: Yes - Number of early resorptions: Yes- Number of late resorptions: Yes- Other: Five mated rats from each of the treatment and ten from the control group were selected by random numbers for natural parturition. This enabled observations on litter size, weight and infant mortality to be recorded, together with any other observable postpartum expression of response to treatment for a period of 21 days (birth to weaning).
Fetal examinations:
- External examinations: Yes- Soft tissue examinations: Yes- Skeletal examinations: Yes- Head examinations: No

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yesDetails on maternal toxic effects:At 500 mg/kg bw/day, the test substance produced maternal toxicity associated with severe diarrhoea, reduced food intake and reduced body weight gain. There was one death in this group and two animals were killed prior to full term. The survivors showed an increased number of intrauterine deaths and a reduction in live foetal body weight. These foetuses showed evidence of toxic retardation, with delayed ossification and also an increased incidence of supernumerary cervical ribs and shortened thoracic ribs. There were no gross external or visceral anomalies which could be attributed to treatment. No maternal toxic effects were seen in the other treatment groups and there were no effects on live foetal numbers, body weight or crown-rump distance. There was no evidence of a specific external, gross viscera1 or skeletal defect which could be attributed to treatment. There was no indication of a treatment effect on pups born by natural parturition and reared to weaning age of 21 days.

Effect levels (maternal animals)

Dose descriptor:
Effect level:
250 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Basis for effect level:
other: No toxic effects.

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:Effects were only seen in the presence of maternal toxicity.85586-07-8

Effect levels (fetuses)

Dose descriptor:
Effect level:
250 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Basis for effect level:
other: No toxic effects.

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Treatment of pregnant rats with Alfol 12-14 sulphate at 500 mg/kg bw/day induced a maternal toxic response and this was reflected in the conception which showed toxic retardation. At 250, 125 and 63 mg/kg bw/day, Alfol 12-14 sulphate did not cause maternal toxicity or foetotoxicity and did not show teratogenic potential.