Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted in compliance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Principles of method if other than guideline:
The method was similar to OECD 401. Higher dose volumes (up to 16 mL/kg) than recommended by the guideline (<10 mL/kg) were administered.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sample 1
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: >96%
- Purity test date: No data
- Lot/batch No.: No data

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 90-124 grams
- Fasting period before study: Overnight
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: None

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg body weight
Doses:
1, 4, 16 mL/kg bodyweight (1100, 4400, and 17600 mg/kg)
No. of animals per sex per dose:
At 1100 and 4400 mg/kg 2/sex/group were utilized. At 17600 mg/kg, 5/sex/group were utilitzed.
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed daily and weighed weekly.
- Necropsy of survivors performed: yes, gross necropsy
- Other examinations performed: clinical signs, body weight, gross necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 17 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality occurred during the study.
Clinical signs:
Clinical signs observed shortly after dosing included piloerection and hunched posture (dose group not specified). Diuresis and diarrhea was observed in 4 of 10 rats (dose group not specified). All rats were normal by 3 days after dosing.
Body weight:
Body weights were normal throughout the study.
Gross pathology:
No abnormal findings were observed upon gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the oral LD50 of the test article is greater than 16 mL/kg (17,600 mg/kg).
Executive summary:

 The acute oral toxicity of the test article (liquid, lot not reported) was evaluated in male and female rats (strain unknown). The test article was tested as received. A rangefinder was conducted with rats (2/sex/group) receiving 1, 4, or 16 mL/kg test article (equivalent to up to 17,600 mg/kg) via oral gavage. All rats survived the rangefinder so a definitive study was performed. Rats in the definitive study (5/sex/group) received water or 16 mL/kg test article via oral gavage. The rats were observed daily for 14 days. Body weights were recorded weekly. All animals survived. Piloerection and hunched posture were observed shortly after dosing. Diuresis and diarrhea was observed in 4 of 10 rats. All rats were normal by 3 days after dosing. Body weights were normal throughout the study. Based on the results of this study, the oral LD50 of the test article is greater than 17,600 mg/kg.