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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-03-13 to 1991-03-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

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 5 animals (mice) tested (female), observation time only 6 d after treatment, no necropsy, analytical purity of test substance not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl palmitate
EC Number:
205-571-1
EC Name:
Isopropyl palmitate
Cas Number:
142-91-6
Molecular formula:
C19H38O2
IUPAC Name:
propan-2-yl hexadecanoate
Details on test material:
- Name of test material (as cited in study report): palmitate isopropyle
- Physical state: liquid, clear
- Batch/Lot Nr.: 0412D

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 19 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: daily, body weight before and at the end of the study.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
other: No abnormality observed

Any other information on results incl. tables

Single administration of the test substance at 5000 mg/kg bw to female mice had no effects on clinical signs, viability or body weight change in the observation period of 6 days. Although there was a short observation time, the lack of any symptomes within this time gave evidence, that the test substance has not to be classified according to DSD and CLP.

Applicant's summary and conclusion

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

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