Registration Dossier
Registration Dossier
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EC number: 230-786-2 | CAS number: 7320-37-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
- Principles of method if other than guideline:
- Ten male Wistar rats were exposed to test substance dissolved in olive oil via oral gavage. Animals received 5000 mg/kg bw. Animals were observed for 7 days and the LD50 was determined.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Decyloxirane
- EC Number:
- 220-667-3
- EC Name:
- Decyloxirane
- Cas Number:
- 2855-19-8
- IUPAC Name:
- 2-decyloxirane
- Details on test material:
- - Name of test material (as cited in study report): Edenol 817 RV
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Weight at study initiation: mean 160 g
- Fasting period before study: 16 hours
- Housing: five animals per cage, in Makrolon 3 cages with Weichholzgranlat bedding (ARWI-Center Essen)
- Diet: ad libitum, Altromin-Haltungsdiät 1324, Fa. Altromin GmbH, 4937 Lage, Germany
- Water: ad libitum, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 % (g/v)
- Amount of vehicle (if gavage): 20 mL/kg - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: Clinical signs and mortality: multiple days on the day of administration and twice daily on the following days
- Necropsy of survivors performed: no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Diarrhea was observed in all animals. Effect was reversible.
- Gross pathology:
- Gross pathology was not performed.
Applicant's summary and conclusion
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