Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

analogue approach for alkylsulfates contained in registered substance - see attached read across justification.

Data source

Reference

Reference Type:

publication

Title:

Assessment of the teratogenic potential of surfactants - Part I - LAS, AS and CLD

Author:

Palmer et al.

Year:

1974

Bibliographic source:

Toxicology, 3 (1975) 91-106

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

lack of details on test substance, intervals in dose range

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dodecyl sulphate

EC Number:

205-788-1

EC Name:

Sodium dodecyl sulphate

Cas Number:

151-21-3

Molecular formula:

C12H26O4S.Na

IUPAC Name:

sodium dodecyl sulfate

Constituent 2

Reference substance name:

Sodium lauryl sulfate

IUPAC Name:

Sodium lauryl sulfate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Alcohol sulphate
- Physical state: no data
- Purity test date: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

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 6-18

Frequency of treatment:

daily

Duration of test:

Day 1-29

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.2 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

2 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

300 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

600 mg/kg bw/day (nominal)

No. of animals per sex per dose:

13

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: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes

Fetal examinations:

- External examinations: No data
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No

Statistics:

Yes

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg. At dosages that were either non-toxic or only slightly to moderately toxic to the dam, litter parameters were essentially unaffected.

Dermal irritation (if dermal study):

not specified

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Gross pathological findings:

no effects observed

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not examined

Maternal developmental toxicity

Number of abortions:

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Pre- and post-implantation loss:

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Total litter losses by resorption:

effects observed, treatment-related

Description (incidence and severity):

Marked maternal toxicity in the form of anorexia, weight loss, cachexia, death and abortion (and/or total resorption) was evident in rabbits and mice with AS 600 mg/kg.

Early or late resorptions:

not specified

Dead fetuses:

not specified

Changes in pregnancy duration:

not specified

Description (incidence and severity):

Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified

Changes in number of pregnant:

not specified

Other effects:

not specified

Details on maternal toxic effects:

Maternal toxic effects:yes

Effect levels (maternal animals)

1

Key result

Dose descriptor:

NOAEL

Effect level:

300 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

clinical signs

other: maternal toxicity

2

Dose descriptor:

LOAEL

Effect level:

600 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

clinical signs

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

> 600 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

no effects observed

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No maternal toxicity and no developmental toxicity up to 300 and 600 mg/kg/day was reported for sodium lauryl sulfate, respectively.