Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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

Constituent 1
Chemical structure
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 / concentrationsopen allclose all
Dose / conc.:
0.2 mg/kg bw/day (nominal)
Dose / conc.:
2 mg/kg bw/day (nominal)
Dose / conc.:
300 mg/kg bw/day (nominal)
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)

open allclose all
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
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.