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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
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals

Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation:7-8 weeks
- Weight at study initiation:179-215 g
- Housing:The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22+3
- Humidity (%):55+15
- Air changes (per hr):approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light):12 hours light/day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceutical Division, Ciba-Geigy Ltd.).
Details on oral exposure:
- Amount of vehicle (if gavage): 20 ml/kg
The animals were allocated to the different dose groups by random selection.
Prior to dosing, the animals were fasted overnight.
Doses:
5000 mg/kg bw.
No. of animals per sex per dose:
5 males/5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No
- Other examinations performed: mortality, symptoms, autopsy, body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, a transient diarrhea and tremor was observed.
The surviving animals recovered within 10 days.
Body weight:
None
Gross pathology:
No gross lesions were found at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of FAT 46014/F in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg.
Executive summary:

Upon an acute oral administration and 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for FAT 46014/F.

LD50 in male rats: >5000 mg/kg bw

LD50 in female rats: >5000 mg/kg bw

LD50 in rats of both sexes : >5000 mg/kg bw