Registration Dossier
Registration Dossier
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EC number: 246-791-8 | CAS number: 25291-17-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Feb - 12 Apr 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted Feb 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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:
- male/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: 7 weeks (males); 9 weeks (females)
- Weight at study initiation: 232.2 - 255.7 g (males); 207.4 - 226.7 g (females) (ranges)
- Housing: The animals were housed individually in the barrier-system animal room in stainless steel cages with mesh floor (W 260 x D 380 x H 180 mm).
- Diet: Pelleted diet (MF, lot number 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: 07 Mar 2017 To: 21 Mar 2017
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 5 x 10 cm clipped skin of the dorsal area of trunk.
- Type of wrap: The dosing formulation on a non-woven gauze was applied over the clipped dorsal area and fixed by elastic adhesive bandage (Silkytex5, lot # 51113254, Alcare).
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with purified water (lot # PC160915, Takasugi Pharmaceutical) and absorbent cotton.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 1.28 mL/kg bw
- Concentration: 100% - Duration of exposure:
- 24 h
- 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 once 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. Application site, external surface of the body, all orifices, subcutis, cranial, thoraic, abdomial and pelvic cavities with their contents were observed.
Results and discussion
Effect levels
- Key result
- 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.
- Clinical signs:
- other: Slight decreased spontaneous locomotion was sporadically observed in all animals of both sexes from 5 min to 3 h after dosing. The latter mentioned clinical sign of toxicity disappeared in all animals after removal of the non-woven gauze and elastic adhes
- 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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