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EC number: 459-330-2 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05/Nov/2002 - 08/Nov/2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether
- EC Number:
- 609-858-6
- Cas Number:
- 406-78-0
- Molecular formula:
- C4H3F7O
- IUPAC Name:
- 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Sponsor's identification: 2,2,2-Trifluoroethyl-1,1,2,2-Tetrafluoroethyl-ether (CAS 406-78-0)
Description: Clear colourless liquid
Batch number: S728010
Date received 09 September 2002
Storage conditions: Room temperature in the dark
Absorption of the test material was not determined. Determination of the pH of the test material was attempted but could not be determined.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits were supplied by David Percival Ltd, UK. At the start of the study, the animals were 12-20 weeks old and weighed between 2.0 and 3.5kg. After a 5 day acclimitisation period, each animal was given a unique number within the study, which was written with a black indelible marker-pen on the inner surface of the ear and the cage label. The animals were individually housed in suspended metal cages, with free access to mains drinking water and food. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. The temperature and relatively humidity were set to achieve limits of 17°C and 30-70% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 - 18:00) and 12 hours darkness. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 Hours
- Number of animals:
- 3
- Details on study design:
- On the day before the test, each of the 3 rabbits were clipped free of fur from the dorsal/ flank area using veterinary clippers. Only animals with a healthy, intact epidermis by gross observation were selected for the study.
On the day of the test, a suitable test site was selected on the back of each rabbit. 0.5ml of the test substance was introduced under a 2.5cm x 2.5cm cotton gauze patch and placed in position on the shorn skin and secured with surgical adhesive tape. The truck of each rabbit was wrapped in an elasticated corset to prevent interference. The animals were returned to their cages for the duration of the exposure period.
Four hours post application, the corset and patches were removed from each animal and any residual test material was removed by gently swabbing with cotton wool soaked in distilled water. Approx. one following removal of the patches and than at 24, 48 and 72 hours post removal, the test sites were examined for evidence of primary irritation. Any other skin reactions, if present, were also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- There were no other effects seen
Any other information on results incl. tables
The table below summarises the individual scores for erythema/ eschar and oedema:
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
62 Male |
85 Male |
86 Male |
|||
Erythema/ Eschar Formation |
1 Hour |
0 |
0 |
0 |
(0) |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
(0) |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-hour Readings (S): 0 |
|||||
Primary Irritation Index (S/6): 0/6 = 0.0 |
|||||
Classification: Non-Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin, according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin, according to the Draize classification scheme. No corrosive effects were noted.
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