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EC number: 700-736-9 | CAS number: 2149571-40-2
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 september 2009 to 08 October 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD guideline and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- EC Number:
- 700-736-9
- Cas Number:
- 2149571-40-2
- Molecular formula:
- C14H14
- IUPAC Name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- Details on test material:
- - Name of test material (as cited in study report): MTF
- Substance type: Organic
- Physical state: colourless liquid
- Analytical purity: 98.6%
- Lot/batch No.: 20080625005
- Expiration date of the lot/batch: 22 June 2014
- Storage condition of test material: refrigerated
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan
- Age at study initiation: 9 weeks
- Weight at study initiation: 194 to 227 g
- Fasting period before study: 16 to 17 hours
- Housing: individual
- Diet (e.g. ad libitum): ad libitum from 4 hours afer dosing
- Water (e.g. ad libitum): adlibitum from 4 hours after dosing
- Acclimation period: >6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 deg C
- Humidity (%): 55%
- Air changes (per hr): 10-20 changes per hour
- Photoperiod (hrs dark / hrs light):12 hrs dark/12 hrs light
IN-LIFE DATES: From: 17 September 2009 To: 15 October 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bodyweight
- Justification for choice of vehicle:
- Lot/batch no. (if required): V8A6289
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg bodyweight
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: guideline - Doses:
- Experiments 1 and 2: 300 mg/kg
Esperiment 3: 2000 mg/kg - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical Obs: pre-dose, 0.5, 1, 2, 3 and 4 hrs on day of dosing, daily from Days 2 to 15.
Body weight measurements: before administration and 1, 3, 7 and 14 days after administration.
Pathology of organs and tisues on Day 15
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- Experiments 1 and 2 (300 mg/kg bodyweight): mucous stool observed in 1 and 2 animals in experiments 1 and 2 respectively at 1 or 4 hours after dosing. Soiled periproctal regoin in 2 animals in Experiments 1 at 2 hrs after dosing or on day following administration. The findings disappeared by 2 days after administration.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 Cut-off value based on 0/6 deaths seen at 300 mg/kg and 2/3 deaths at 2000 mg/kg.
- Mortality:
- Two animals died in experiment 3 (2000 mg/kg bodyweight)
- Clinical signs:
- other: Experiments 1 and 2: Mucous stool observed in 1 and 2 animals in experimetns 1 and 2 respectively, at 1 or 4 hours after dosing. soiled periproctal region in 2 animals in experiment 1 at 2 hours after dosing. Experiment 3: For the dead animals, one sh
- Gross pathology:
- No abnormalities observed at necropsy in any experiment including dead animals.
Applicant's summary and conclusion
- Conclusions:
- The LD50 cut off value of MTF was estimated to be 1000 mg/kg under the conditions of this study since death occurred in 2 animals at 2000 mg/kg.
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