Registration Dossier
Registration Dossier
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EC number: 695-022-6 | CAS number: 473278-76-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 July - 17 Aug 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 Dec 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147
- Version / remarks:
- amended 10 Dec 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH, UK
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione
- Cas Number:
- 473278-76-1
- Molecular formula:
- C20 H23 Cl O7 S
- IUPAC Name:
- 2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl: CD (SD) IGS BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 184 - 232 g
- Fasting period before study: overnight fast immediately before dosing and for approximately 3 to 4 h after dosing
- Housing: in groups of three in suspended solid-floor polypropylene cages on woodflakes, environmental enrichment items were provided
- Diet: certified Rat and Mouse Diet, Code 5LF2 (BCM IPS Limited, London, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: the test material did not dissolve/suspend in distilled water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: all available information on the toxicity of the test substance was used - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females in total
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- Hunched posture was noted in one animal 2 and 4 h after dosing. Five animals appeared normal throughout the study and the remaining animal appeared normal one day after dosing.
- Body weight:
- All animals showed expected gains in body weight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this acute oral toxicity study a LD50 cut-off value of 5000 mg/kg bw in female rats was found.
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