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Toxicological information

Acute Toxicity: oral

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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:
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:
read-across source
Qualifier:
equivalent or similar to
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 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:
1982
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals 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.