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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:
key study
Study period:
03 Mar - 09 Mar 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Lack of study details and no information on analytical purity of the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of study details; no information on analytical purity of the substance
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Stearic acid, monoester with glycerol
EC Number:
250-705-4
EC Name:
Stearic acid, monoester with glycerol
Cas Number:
31566-31-1
Molecular formula:
C21H42O4
IUPAC Name:
1,3-dihydroxypropan-2-yl octadecanoate 2,3-dihydroxypropyl octadecanoate
Details on test material:
- Name of test material (as cited in study report): Stearate de Glycerol
- Analytical purity: no data
- Lot/batch No.: 1412F

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 20-21 g
- Fasting period before study: 4 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were reported during the 6-day observation period.
Clinical signs:
Within the first hour post-administration, clinical observations included eyes half closed, shortness of breath and apathy. Two hours after administration, animals received their normal diet and no clinical signs were noted at this time point.
Body weight:
All treated animals showed the expected gain in body weight.
Gross pathology:
No abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified