Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 March 1987 - 27 March 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD and EPA guidelines and EEC regulations
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
The test material, a clear colourl ess liquid. was stored in the dark under ambient conditions.

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 6-8 weeks old
- Weight at study initiation: 20-30 g
- Fasting period before study: 4-6 hours
- Housing: suspended polypropylene cages wi th stainl ess steel grid tops and with woodshavings for bedding
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
Dose ranging: 100, 500, 1000, 3000 and 5000 mg/kg
Main study: 2000 and 5000 mg/kg
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately prior to dosing, 7 days after dosing and at the end of the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
No clinical signs were noted at any time after dose administration .
No deaths occurred and no abnormal ities were noted at.gross post mortem examination.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs were noted at any time after dose administration.
Body weight:
Body weight gains were within the acceptabl e range.
Gross pathology:
No abnormalities were noted at gross post mortem examination .

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following acute oral adminstration of the test item to male and female CD-1 mice, no deaths occurred.
It is concluded that the Median Oral lethal Dose (LD50) is greater than 5000 mg/kg.