Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Remarks:
Short-term Toxicology CIBA-GEIGY Limited
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid; white
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif:RAI f1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 178 to 202 g
- Fasting period before study: overnight
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Because of precipitation of the test article in the indicated vehicle, carboxymethylcellulose in aqueous polysorbate had to be used instead of distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10ml/kg
Doses:
2000mg/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: daily for 14 days; weighing: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
Piloerection, hunched posture, and dyspnea were seen. Additionally, reduced locomotor activity and ataxia was observed in all animals during the administration day. The males experienced tremor at the same time. The animals recovered within 6 days.
Body weight:
no abnormalities observed
Gross pathology:
At necropsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 value in rats of greater than 2000 mg/kg body weight was established.