Registration Dossier
Registration Dossier
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EC number: 947-787-5 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not specified.
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Not specified.
- Statistics:
- Not specified.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- Practically non-toxic.
- Clinical signs:
- Practically non-toxic.
- Body weight:
- Practically non-toxic.
- Gross pathology:
- Practically non-toxic.
- Conclusions:
- The LD50 for rats was >5000 mg/kg body weight for glyceryl stearate.
- Executive summary:
Rats were used for this study. The test substance, glyceryl stearate, was administered via oral gavage at a dose of 5000 mg/kg to groups of 5 rats. Due to a lack of toxic effects, and the test material being practically non-toxic, the LD50 of glyceryl stearate was determined to be >5000 mg/kg body weight.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report of the safety assessment of lithium stearate, aluminum distearate, aluminum stearate, aluminum tristearate, ammonium stearate, calcium stearate, magnesium stearate, potassium stearate, sodium stearate and zinc stearate
- Author:
- Cosmetics Ingredients Review
- Year:
- 1 982
- Bibliographic source:
- Journal of the American college of toxicologists, vol. 1, issue 12, pp. 143-177
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Glycerol 1-stearate
- EC Number:
- 204-664-4
- EC Name:
- Glycerol 1-stearate
- Cas Number:
- 123-94-4
- Molecular formula:
- C21H42O4
- IUPAC Name:
- 2,3-dihydroxypropyl stearate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not specified.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Not specified.
- Statistics:
- Not specified.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- Practically non-toxic.
- Clinical signs:
- Practically non-toxic.
- Body weight:
- Practically non-toxic.
- Gross pathology:
- Practically non-toxic.
Applicant's summary and conclusion
- Conclusions:
- The LD50 for rats was >5000 mg/kg body weight for glyceryl stearate.
- Executive summary:
Rats were used for this study. The test substance, glyceryl stearate, was administered via oral gavage at a dose of 5000 mg/kg to groups of 5 rats. Due to a lack of toxic effects, and the test material being practically non-toxic, the LD50 of glyceryl stearate was determined to be >5000 mg/kg body weight.
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