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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (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
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

Constituent 1
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 or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 215 g - 237 g; females: 145 g - 163 g
- 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
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No significant signs of toxicity in females but males showed slight toxicity following a 2000 mg/kg bw dose.
Body weight:
Initial loss of weight (due to predose fasting) with normal weight gain after dosing.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.

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