Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 March 1987 to 31 March 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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
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)
- Analytical purity: 91.6%
- Expiration date of the lot/batch: not specified

Test animals

Species:
rat
Strain:
other: Tif RAIf rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation:7 - 8 weeks
- Weight at study initiation: 210 - 254 g
- Fasting period before study: not applicable
- Housing: not specified
- Acclimation period: not specified

IN-LIFE DATES: From: 17.03.1987 To: 31.03.1987

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.5% carboxymethylcellulose and 0.1% polysorbate 80 in distilled water
Details on dermal exposure:
The application site was covered with gauze pad which was held in place for 24 hours with a tape
Duration of exposure:
24 hours
Doses:
2000 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: animals weighed at weekly intervals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, and dermal reactions
Statistics:
No statistical analysis needed. LD50 estimated from limit dose administration

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effects at limit dose level
Mortality:
No deaths occurred following topical administration of a dose of 2000 mg/kg bw
Clinical signs:
Slight dyspnoea, curved body position and slight sedation were reported. Complete recovery was reported within 12 days after treatment
Body weight:
Bodyweights not reported
Gross pathology:
No macroscopic abnormalities noted during necropsy
Other findings:
Not applicable

Any other information on results incl. tables

The dermal LD50 was found to exceed the limit dose of 2000 mg/kg bw administered in this study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 for rats determined for both sexes, was greater than 2000 mg/kg bw
Executive summary:

Test material: CGA185072 technical, purity 91.6%, batch P. 607001/002. Cloquintocet-mexyl was administered as a suspension in 0.5% carboxymethylcellulose and 0.1% polysorbate 80 in distilled water, applied to the shaved dorsum of five male and five female Tif RAIf rats at a single dose level of 2000 mg/kg body weight. The application site was covered with gauze pad which was held in place for 24 hours with a tape. The animals were observed for symptoms of toxicity and mortality for 14 days and then subjected to necropsy procedures. No mortality occurred. Clinical signs of reaction to treatment were limited to commonly observed effects including dyspnoea, curved body position and slight sedation. Recovery was complete within 12 days. At necropsy there were no deviations from normal morphology. The dermal LC50 was greater than 2000 mg/kg bw.