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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- State of aggregation: liquid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:
other: rat, Tif:RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Switzerland
- Age at study initiation: Young adult 6 to 8 weeks
- Weight at study initiation: 177 to 205 g
- Fasting period before study: fasted overnight
- Housing: group-housed = 5 animals per cage
- Diet (e.g. ad libitum): Rat chow (NAFAG 890 Tox, NAFAG,Gossau, Switzerland) was provided ad libitum.
- Water (e.g. ad libitum): water were provided ad libitum
- Acclimation period: at least for 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2
- Humidity (%): 55 + 10 %.
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hour/12 hour

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd,, Basel)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight
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: Mortality was observed twice daily at a.m. and p.m. on working days and a.m. on weekend days. Signs and symptoms were noticed daily. Body weight was examined immediately before administration and on days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period.
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of specific toxicity
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Piloerection, hunched posture, exophthalmos, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 to 6 days.
Body weight:
The mean body weights of the animals were in the normal range throughout the study period.
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met