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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 August 1990 to 22 October 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
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:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was administered undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Michigan
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adults
- Weight at study initiation: 205-267 g
- Fasting period before study: 16 hours
- Housing: Housed individually in conventional design stainless steel, wire mesh bottom cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: not specified

DOSAGE PREPARATION (if unusual): undiluted

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: standard method used
Doses:
2000 mg/kg bw
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: Observed frequently on the day of dosing and twice a day thereafter. Animals were weighed prior to dosing, then at 24 hours after dosing and on days 7 and 14 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female died spontaneously. No other deaths were recorded.
Clinical signs:
No clinical signs of systemic toxicity were noted in any of the animals.
Body weight:
No apparent effects were noted in body weight gain and food consumption.
Gross pathology:
The female that died spontaneously showed gross tissue changes consistent with acute gastritis with regurgitation and inspiration of test material. No such lesions were reported in the rest of the animals. Therefore, this change was considered to be due to gavage treatment. No gross macroscopic changes were noted in the rest of the animals.
Other findings:
- Organ weights: not examined
- Histopathology: not examined
- Potential target organs: not examined

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute oral toxicity study, conducted to the now-deleted OECD 401 Test Guideline and in compliance with GLP, an LD50 value of >= 2000 mg/kg bw was reported.