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EC number: 696-317-2 | CAS number: 174489-76-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Female rats: The clinical observations at the 3 hour observation period were recorded at 3 hours and 15 minutes after treatment. Body weight of all females were inadvertently not recorded on day 7 after treatment.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- prop-2-en-1-yl 2-(2-chloro-5-nitrobenzoyloxy)-2-methylpropanoate
- EC Number:
- 696-317-2
- Cas Number:
- 174489-76-0
- Molecular formula:
- C14H14ClNO6
- IUPAC Name:
- prop-2-en-1-yl 2-(2-chloro-5-nitrobenzoyloxy)-2-methylpropanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd. Biotechnology & Animal Breeding Division. 4414 Füllinsdorf / Switzerland.
- Age at study initiation: Young adult (approximately 7 - 11 weeks).
- Weight at study initiation: 178 - 190 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Three same sex animals per cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13-14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% (w/v) in 0.1 % (w/v) aqueous polysrbate 80.
- Details on oral exposure:
- - Dose level: 2000 mg/kg
- Vehicle: 0.5% (w/v) CMC (carboxy methyl cellulose) in 0.1% (w/v) aqueous polysrbate 80.
- Concentration: 3000.4 mg test item with vehicle ad 15 ml (males)
2000.6 mg test item with vehicle ad 10 ml (females)
- Volume applied: 10 ml/kg
- Rationale for the selection of the starting dose: The dose level of 2000 mg/kg for the limit test was selected based on the OECD/EEC
guidelines and pre-tests. - Doses:
- One single dose by gavage.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Period of observation: 14 days.
- Clinical observations: Checked and recorded individually at 1, 3 or 4 and 5 hours after dosing, then daily for the duration of the observation period.
- Mortality: Checked twice daily, morning and afternoon.
- Body weight: Measured and recorded immediately before dose administration, then on days 7 and 14.
Results and discussion
- Preliminary study:
- The dose level of 2000 mg/kg for the limit test was selected ased on the OECD/EEC guidelines and pre-test results.
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:
- There was no mortality in the study.
Threrefore, the following acute oral LD50 values were determined for CA 2218 A (Intermediate CGA 276854):
LD50 in male rats: Greater than 2000 mg/kg body weight
LD50 in female rats: Greater than 2000 mg/kg body weight
LD50 in rats of both sexes: Greater than 2000 mg/kg body weight - Clinical signs:
- other: There were no in-life observations indicating treatment-related systemic effects for any animal.
- Gross pathology:
- Necropsy examinations revealed no observable abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The following acute oral LD50 values were determined for CA 2218 A Intermediate of CGA 276854):
LD50 in male rats: Greater than 2000 mg/kg body weight
LD50 in female rats: Greater than 2000 mg/kg body weight
LD50 in rats of both sexes: Greater than 2000 mg/kg body weight - Executive summary:
Groups of 3 male and 3 female rats were administered a single dose of CA 2218 A (Intermediate CGA 276854), batch no. OP 802002, by gavage at a dose level of 2000 mg/kg, followed by a 14 day post-treatment observation period.
There was no mortality in the study.
There were no in-life observations indicating treatment-related systemic effects for any animal.
Body weights were not affected by the treatment.
Necropsy examinations revealed no observable abnormalities.
The following acute oral LD50 values were determined for CA 2218 A Intermediate of CGA 276854):
LD50in male rats: Greater than 2000 mg/kg body weight
LD50in female rats: Greater than 2000 mg/kg body weight
LD50in rats of both sexes: Greater than 2000 mg/kg body weight
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