Registration Dossier
Registration Dossier
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EC number: 246-791-8 | CAS number: 25291-17-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Feb - 21 Mar 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted Feb 2002
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene
- EC Number:
- 246-791-8
- EC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene
- Cas Number:
- 25291-17-2
- Molecular formula:
- C8H3F13
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene
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: Charles River Laboratories Japan (Hino Breeding Center)
- Age at study initiation: 8 weeks
- Weight at study initiation: 176.5 g (sighting study); 174.1 - 181.6 g (main study) (ranges)
- Fasting period before study: Yes, the animals were fasted for 17 - 19 h before dosing.
- Housing: The animals were housed in the barrier-system animal rooms in stainless steel cages with mesh-floor (W 260 x D 380 x H 180 mm) before the group allocation and in stainless steel cages with mesh-floor (W 165 x D 300 x H 150 mm) after the group allocation.
- Diet: Pelleted diet (MF, lot number 160915 and 161118, Oriental Yeast), ad libitum
- Water: Chlorinated water (chloric level maintained at 3 - 5 ppm by adding sodium hypochlorite), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Sighting study: From: 21 Feb 2017 To: 07 Mar 2017; Main study: From: 23 Feb 2017 To: 09 Mar 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- including 3% (w/v) Tween80
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3% (w/v) Tween80
- Amount of vehicle (if gavage): 20 mL
- Justification for choice of vehicle: The test substance was homogenously suspended to olive oil including 3% (w/v) of Tween80. Additionally, the condition of the formulation such as colour did not change at room temperature 4 h after the preparation. Therefore, olive oil including 3% (w/v) Tween80 was selected as vehicle.
- Lot/batch no.: 605027 (olive oil) and ECE6558 (Tween80)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed continuously for 10 min, and 30 min and 3 h after dosing on the administration day, and thereafter once in the morning during the observation period. Body weights of all animals were recorded before dosing, and on Day 1, 7 and 14 after dosing with an electric balance.
- Necropsy of survivors performed: Yes, the animals were euthanized by bleeding from the abdominal aorta under isoflurane anesthesia. External surface of the body, all orifices, subcutis, cranial, thoraic, abdomial and pelvic cavities with their contents were observed.
Results and discussion
- Preliminary study:
- In the sighting study one female was dosed at 2000 mg/kg bw. No clinical signs was observed after dosing. Based on this result, additional 4 females were dosed at 2000 mg/kg bw in the main study.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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