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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study performed under GLP-like quality controlled conditions with QAU statement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAIf(SPF), F3-hybrid 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, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 168 to 201 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 6 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bodyweight
Doses:
5000 mg/kg bodyweight
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: daily
- Frequency of weighing: on days 1, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities observed.
Clinical signs:
Dyspnea, ruffled fur and curved body position. The animals recovered within 11 days.
Gross pathology:
No deviations from normal morphology were found.

Any other information on results incl. tables

Body weights and standard deviations

   males              females
 dose (mg/kg)  day 1 day 7  day 14  day 1  day 7  day 14 
 5000  193g / 6.6 260g / 7.6  307g / 11.8  179g / 11.7  211g / 10.1  222g / 4.3 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test substance in male and female rats is greater than 5000 mg/kg body weight.
Executive summary:

Five male and five female Tif: RAIf(SPF) rats were treated with the test substance by oral gavage administration at a dosage of 5000 mg/kg body weight. The test item was diluted in distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 and administered at a volume dosage of 20 mL/kg. All animals survived until the end of the study period. Clinical signs were dyspnea, ruffled fur, and curved body position, being common symptoms in acute tests. The animals recovered within 11 days. Body weight gains were normal, no macroscopic findings were recorded at necropsy. In conclusion, the median lethal dose of the test substance after single oral administration to male and female rats, observed over a period of 14 days is greater than 5000 mg/kg body weight.