Registration Dossier
Registration Dossier
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EC number: 233-401-6 | CAS number: 10141-00-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422 combined repeat dose/reproductive/developmental toxicity study
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Potassium sulfate
- EC Number:
- 231-915-5
- EC Name:
- Potassium sulfate
- Cas Number:
- 7778-80-5
- Molecular formula:
- H2O4S.2K
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Duration of treatment / exposure:
- Animals in the study were divided between two subgroups (toxicity and reproductive subgroups). Details of toxicity subgroup found in section 5.4. The exposure period for reproductive subgroup males was at most 28 days. The exposure period for reproductive subgroup females was at most 53 days (14 days pre-mating, 14 days mating, and gestational and lactational periods up to lactation day 4).
- Frequency of treatment:
- Daily
- No. of animals per sex per dose:
- 5 males, 10 females
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- 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:no data
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (actual dose received)
- Based on:
- not specified
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: 1500 mg/kg bw
Maternal abnormalities
- Localisation:
- other: not detrmined
- Description (incidence and severity):
- Not determined
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no data
Effect levels (fetuses)
- Dose descriptor:
- other:
- Remarks:
- not specified
- Effect level:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not determined
- Remarks:
- not determined
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not determined
- Description (incidence and severity):
- Not determined due to low toxycity
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects observed
- Executive summary:
No adverse effects observed.
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