Registration Dossier
Registration Dossier
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EC number: 614-070-0 | CAS number: 674773-12-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- and EU Method B.1 92/69/EEC
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate
- Cas Number:
- 674773-12-7
- Molecular formula:
- C10H10N2O4S
- IUPAC Name:
- methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: solid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 812691/019
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other: brown to yellow greenish powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Iffa Crédo, 69210, L'Arbrelse, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: males: 174 ± 4 g
females: 147 ± 2 g
- Fasting period before study: overnight (ca. 18 hours)
- Housing: one to seven of the same sex / cage during acclimation period and 5 rats of the same sex and group / cage
during the treatment period in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm)
- Diet (e.g. ad libitum): ad libitum, A04 C pelleted diet by UAR, 91360 Villemoisson-sur-Orge, France
- Water (e.g. ad libitum): ad libitum, drinking water, filtered by FG Millipore membrane 0.22 micron
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 C
- Humidity (%): 30-70 %
- Air changes (per hr): 12 / hour (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: MC (methylcellulose) 0.5 %
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg / ml vehicle suspension
- Amount of vehicle (if gavage): 10 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 10 ml / kg
- Doses:
- 2000 mg / kg bodyweight
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : frequently during the hours administration following then once a day
weighing: days 1, 8 and 15
- Necropsy of survivors performed: yes (macroscopic examination).
- Other examinations performed: none.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical signs
- Gross pathology:
- No apparent abnormalities were observed at necropsy in any animal.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under our experimental conditions the oral LD50 of the test susbtance is higher than 2000 mg/kg in rats.
No signs of toxicity were observed at this dose. The test substance should not be classified according to EU regulations.
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