Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
ACUTE ORAL TOXICITY OF SELECTED FLAVOR CHEMICALS
Author:
Moran, E. J., Easterday, O.D., Oser, B. L.
Year:
1980
Bibliographic source:
DRUG AND CHEMICAL TOXICOLOGY, 3(3) , 249-258 (1980)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: FDRL
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: fasted overnight prior treatment
- Diet: Purina Laboratory Chos, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: closely observed for mortality and pharmacological effects on the day of dossing and daily thereafter for a total of 14 observation days; body weight determination prior to dosing
Statistics:
LD50 values were calculated by appropriate statistical methods, as determined by Miller and Tainter (1944).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Based on:
test mat.
95% CL:
501 - 699
Mortality:
no data
Clinical signs:
no data
Body weight:
40 - 60 g
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 value for the test substance was determined to be 600 mg/kg bw.
Executive summary:

An acute oral toxicity study was conducted on 10 rats (5 male and 5 female animals). After an overnight fasting period the animals were weighted and the test item was applied by gavage in corn oil. The animals were observed for a period of 14 days. The calculated LD50 for the test item was 600 mg/kg bw.