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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient for assessment due to reduced animal number. Only 2 male and 2 female rats were used, details on test substance not documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: Only two male and two female animals used
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pentaerythritol C7-C10 Tetraester

Test animals

Species:
rat
Strain:
other: Alderley Park SPF albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 215 g - 237 g for males and 145 g - 163 g for females
- Fasting period before study: 24 h

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Frequency of observations and weighing:daily
- Necropsy of survivors performed: yes
- Duration of observation period following administration: Not stated
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No significant signs of toxicity in females but males showed slight toxicity following a 2000 mg/kg dose.
Body weight:
Initial loss of weight (due to predose fasting) with normal weight gain after dosing.
Gross pathology:
No macroscopic findings

Any other information on results incl. tables

The limit dose of 2000 mg/kg showed no mortality in male and female rats. Although only 2 animals per sex were tested, the observations do not indicate a severe toxic effect.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information The acute oral lethal dose was greater than 2000 mg/kg in male and female rats. Criteria used for interpretation of results: EU