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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:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature
Specific details on test material used for the study:
commercial grade

Test animals

Species:
rat
Strain:
other: Tif : RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd. Tierfarm, Sisseln / Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 177 - 217 g
- Fasting period before study: overnight
- Housing: in groups of five
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau / Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: no data

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
(PEG 400)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:
5000 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: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and Symptoms: daily; Body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
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:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities observed.
Mortality:
No mortalities observed.
Clinical signs:
Dyspnoea (day 1 - day 10), exophthalmus (day1 - day 9), ruffled fur (day 1 - day 7), diarrhea (day 1) and curved body position (day 1 - day 5) were observed, being common symptoms in acute tests. In addition a transient sedation was noted. The surviving animals recovered within 11 days.
Body weight:
The body weight of all animals increased during the study period.
Gross pathology:
Besides some enlarged caeca (in 4 male and 2 female animals), no noticeable findings were made at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met