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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:
09.02.1987 to 03.03.1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CGA185072 (company code)
- Name of test material (as cited in study report): CGA185072 technical or cloquintocet-mexyl
- Molecular formula (if other than submission substance): not stated
- Substance type:
- Physical state:
- Analytical purity: 91.6%
- Purity test date: not specified
- Lot/batch No.: P. 607001/002
- Expiration date of the lot/batch: not specifed
- Stability under test conditions: not specified
- Storage condition of test material: not specified

Test animals

Species:
rat
Strain:
other: Tif RAIf (SPF), Sprague-Dawley derived
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd, Animal Production, Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 162-212g
- Fasting period before study: Not specified
- Housing: conventional laboratory cages
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: 5 days


IN-LIFE DATES: From: 09.02.1987 To: 03.03.1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test material was admixed to distilled water containing 0.5% CMC and 0.1% polysorbate 80.
The dosing solution was prepared immediately before administration. The stability was therefore not checked. 10 ml of the solution per kg body weight were applied by gastric intubation. The highest dose group received 20 ml/kg body weight due to the poor solubility of the test material.
Doses:
2000 or 5000 mg/kg bw
No. of animals per sex per dose:
Five per sex per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obsrved hourly for 5 h on day of dosing and twice daily subsequently. Bodyweights recorded pre-test and at weekly intervals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not applicable - median lethal dose exceeded Guideline limit dose of 2000 mg/kg bw

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - ca. 5 000 mg/kg bw
Remarks on result:
other: None of the rats dosed at 2000 mg/kg bw died. One of four males dosed at 5000 mg/kg bw died and two of five females.
Mortality:
None of the rats dosed at 2000 mg/kg bw died. One of four males dosed at 5000 mg/kg bw died and two of five females at the higher dose level.
Clinical signs:
Dyspnea, exophthalmus, ruffled fur and curved body positions were observed in all animals. Recovery was evident by day 13.
Body weight:
No information
Gross pathology:
No macroscopic abnormalities noted among rats dosed at 2000 mg/kg bw
Haemorrhagic lungs and stomachs for one male and two females dosed at 5000 mg/kg bw. Intestinal dilation noted for one female
Other findings:
None

Any other information on results incl. tables

One male dosed at 5000 mg/kg bw died on day 2, the two females decedents died on days 1 and 3.

Dose

Mortality

Day of death

2000 mg/kg
5000 mg/kg

0/ 5
1 / 4


day 2

2000 mg/kg
5000 mg/kg

0 / 5
2 / 5


day 1, 3

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 greater than 5000 mg/kg bw
Executive summary:

Groups of Tif RAIf (SPF), Sprague-Dawley derived rats were dosed with CGA185072 technical, purity 91.6% at doses of 2000 or 5000 mg/kg test material in 0.5% aqueous CMC and 0.1% polysorbate 80.The animals were assessed daily for the following 14 days for any signs of systemic toxicity and their bodyweights recorded at intervals throughout the study.After 14 days surviving rats were sacrificed and subjected to gross necropsy as were those rats which died spontaneously. Dyspnea, exophthalmus, ruffled fur and curved body positions were observed in all animals. At 5000 mg/kg bw one male and two females died. Surviving animals recovered within 13 days. At necropsy, no macroscopic abnormalities were found at 2000 mg/kg. At 5000 mg/kg one male and 2 females showed hemorrhagic lungs and a hemorrhagic stomach. The small intestine of one female was dilated.

The acute oral LD50 of CGA185072 tech. is greater than 5000 mg/kg in male and female rats.