Registration Dossier
Registration Dossier
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EC number: 700-526-7 | CAS number: 1333488-95-1
Acute Toxicity: oral
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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
- EC Number:
- 700-526-7
- Cas Number:
- 1333488-95-1
- Molecular formula:
- C12H7F2NO4
- IUPAC Name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino rat (Tif: RAI f (SPF))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 196-231 g
- Fasting period before study: overnight
- Housing: in Macrolon cages type 4 with standardized soft wood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05.02.1991 To: 21.02.1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% (w/v) CMC in 0.1% (w/v) aqueous polysorbate 80
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: test material practically insoluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - 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: mortality daily a.m. and p.m.; signs and symptoms daily
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross necropsy - Statistics:
- Group means and their standard deviations of body weights were calculated.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured in this study.
- Clinical signs:
- Slight piloerection, hunched posture and dyspnea were observed, which are common signs in acute tests. The animals recovered within 3 days.
- Body weight:
- No impact on the body weight was observed.
- Gross pathology:
- At autopsy a dilated kidney was detected in one female. No deviations from normal morphology were found in the remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- In this acute oral toxicity study in the rat a combined LD50 value of >2000 mg/kg bw was found.
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