Registration Dossier
Registration Dossier
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EC number: 943-447-5 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 - 27 Oct 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate
- Molecular formula:
- C14H22O2
- IUPAC Name:
- Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: (Crl : CD BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 203-222 g (males), 206-228 g (females)
- Fasting period before study: prior to administration until approx. 4 h after dosing
- Housing: up to 5 animals of the same sex per cage in solid-floor polypropylene cages on woodflakes
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 48-61
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- A range-finding study was performed to derive the dose level of the main study (definition of highest dose level which did not produce test substance-related mortality).
- Doses:
- Preliminary study: 500 and 2000 mg/kg bw
Main study: 2000 mg/kg bw - No. of animals per sex per dose:
- Preliminary study: 1
Main study: 5 - Control animals:
- no
- Details on study design:
- Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed 0.5, 1, 2 and 4 h after administration and subsequently once daily for 7 days.
Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2 and 4 h after administration and subsequently once daily for 14 days. Individual body weights were determined prior to dosing and on Days 1, 2, 3, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- No deaths or clinical signs of toxicity were noted at 500 and 2000 mg/kg bw. The dose level selected for the main study was therefore 2000 mg/kg bw.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period of the main study.
- Clinical signs:
- other: No signs indicative for systemic toxicity were noted during the main study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this acute oral toxicity study a LD50 value > 2000 mg/kg bw was derived in male and female rats.
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