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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in accordance with generally accepted scientific principles, but incomplete reporting on methods and results, which do not affect the quality of the relevant results. Study also not performed to GLP and the method used is a non-standardised guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Labelling Act: Hazardous Substances; US Department of Health, Education and Welfare, Food and Drug Administration
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-phenylethyl acetate
EC Number:
202-288-5
EC Name:
1-phenylethyl acetate
Cas Number:
93-92-5
Molecular formula:
C10H12O2
IUPAC Name:
1-phenylethyl acetate
Specific details on test material used for the study:
- Name of test material: 1-phenylethyl acetate
- Name of test material (as cited in study report): USA2850 Methyl Phenyl Carbinyl Acetate

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: 180-200 g- Fasting period before study: 18 hours with water ad libitum- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Remarks:
reported as undiluted
Doses:
5 gm/kg (5000 mg/kg bw)
No. of animals per sex per dose:
Ten animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1, 3, 6 and 24 hours and then every day up to 14 days after treatment- Frequency of observations and weighing: at each time interval- Other examinations performed: pharmacological activity and toxic effects

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
other: mortality
Effect level:
20 other: %
Based on:
test mat.
Mortality:
Two deaths occurred at 24 hours (autopsy revealed respiratory failure).
Clinical signs:
Severe depression, loss of righting reflex, gasping, ataxia, loss of coordination and motor reflex were noted in all animals up to 3 hours. At 6 hours, animals remained depressed with continued loss of righting reflex and ataxia.
Other findings:
All surviving animals returned to normalcy at 24 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, 20% mortality was seen when the test substance was administered orally at 5000 mg/kg bw.
Executive summary:

In a pre-GLP acute oral toxicity study conducted in line with Regulations under the Federal Hazardous Substances Labeling Act: Hazardous Substances, the acute oral toxicity of the test substance was determined to be 20% mortality at 5000 mg/kg bw. The LD50 of the test substance under the conditions of the study can therefore be concluded to be greater than 5000 mg/kg bw.