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EC number: 430-710-1 | CAS number: 15290-77-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1997-09-03 to 1997-09-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- OJ No. L383A, 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 430-710-1
- EC Name:
- -
- Cas Number:
- 15290-77-4
- Molecular formula:
- C5H3F7
- IUPAC Name:
- 1,1,2,2,3,3,4-heptafluorocyclopentane
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 9705-2A
Purity: 98.18%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: selected from a stock supply of healthy male and female CD rats of Sprague-Dawley origin (Hsd: Sprague-Dawley(CD)) which were obtained from Harlan UK Ltd, Bicester, Oxon, England.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately seven to eight weeks
- Weight at study initiation: 200 to 247 g
- Fasting period before study:
- Housing: Housed individually in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water: ad libitum
- Acclimation period: at least six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23
- Humidity (%): 38-65
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 50 mm x 50 mm
- Type of wrap if used: The treatment area was covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of exposure period the dressings was carefully removed and the treated area of skin was washed with warm water (30 to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 1.231 mL/kg bodyweight - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- five males and five females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality: at least twice daily
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1, once in the morning and again at the end of experimental day for subsequent days (with the exception of Day 15 - morning only).
- Dermal responses: assessed daily
- Bodyweight: recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes, All animals were killed on Day 15 by cervical dislocation and subjected to a macroscopic exanimation which consisted of opening the abdominal and thoracic cavities.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- no signs of systemic reaction to treatment observed
- Body weight:
- A slightly low bodyweight gain was recorded for one female on Day 8. All other rats were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No abnormalities were recorded
- Other findings:
- - Dermal Reactions:
Transient slight dermal irritation (Grade 1 erythema only) was seen in two animals on removal of the dressings, and resolving in both instances by Day 4. In addition desquamation (characterised by localised spots/scabbing) was observed in one of these rats from Day 7 through Day 11. No dermal response to treatment was recorded for the remaining eight rats throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute lethal dermal dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute dermal toxicity of test item to the rat following ECB.3.
A group of ten rats (five males and five females) received a single dose by topical application of the test substance administered, as supplied, at a dose level of 2000 mg/kg bodyweight. All animals were kill and examined macroscopically on Day 15, the end of the observation period.
There were no deaths and no signs of systemic reaction to treatment observed throughout the study.
Transient slight dermal irritation (Grade 1 erythema only) was seen in two animals on removal of the dressings, and resolving in both instances by Day 4. In addition desquamation (characterised by localised spots/scabbing) was observed in one of these rats from Day 7 through Day 11. No dermal response to treatment was recorded for the remaining eight rats throughout the study.
A slightly low bodyweight gain was recorded for one female on Day 8. All other rats were considered to have achieved satisfactory bodyweight gains throughout the study.
No abnormalities were recorded at the macroscopic examination on Day 15.
The acute lethal dermal dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.
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