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EC number: 609-534-4 | CAS number: 382-26-3
- 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
Endpoint summary
Administrative data
Description of key information
A Skin Irritation/Corrosion study performed according to OECD 404
guideline and an Eye Irritation study performed according to OECD 405 guideline are reported.
The substance does not meet the classification criteria of Regulation EC No. 1272/2008, both for Skin and Eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 February 2005 to 22 March 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (2004)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France
- Age at study initiation: 13 weeks (male); 12-13 weeks (females)
- Weight at study initiation: 2168 g (male); 1979 - 2115 g (females)
- Housing: individually housed stainless steel cages
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 01-Feb-2005 To: 21-Feb-2005 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml, undiluted
VEHICLE : none - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 (1 male + 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48, 72 hours, then 7, 10 and 14 days after removal of the dressing
SCORING SYSTEM:
- Method of calculation: mean scores across 24, 48, 72 hours scoring times for each animal, and for edema and erythema separately - Irritation parameter:
- erythema score
- Remarks:
- mean score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 14 days
- Irritation parameter:
- erythema score
- Remarks:
- mean score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Remarks:
- mean score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- mean score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- mean score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- mean score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- Scaling was observed at 72 hrs, days 7 and 10 in one animal
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Regulation EC No. 1272/2008, 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane does not meet the classification criteria for skin irritation.
- Executive summary:
The primary skin irritation potential of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact lef flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
The mean erythema/eschar score of the three animals was 2.00, 1.67 and 0.67 respectively and the mean oedema score was 0.67, 0.67 and 0.00, respectively.
The application of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane to the skin resulted in mild to moderate signs of irritation. These included erythema, oedema and scaling. These effects were reversible and were no longer evident 14 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.
Reference
OTHER RESULTS
Viability/Mortality/Clinical signs
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Irritation
The mean score was calculated across 3 scoring times (24, 49 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
Well-defined erythema were observed in the male animal from the 1 -hour to 72 -hour reading and very slight erythema persisted up to the 10 -day reading. Very slight to well-defined erythema was also observed in one female from the 1 -hour reading to the 72 -hour reading, whereas in the other female only very slight erythema was noted from 1 -hour reading to the 48 -hour reading.
Very slight swelling was observed in two animals from the 24- to the 48 -hour reading. Scaling was present in the animal from the 72 -hour to the 10 -day reading.
No abnormal findings were observed on the treated skin of any animal 14 after treatment, the end on the observation time.
Coloration
No staining produced by the test item of the treated skin was observed.
Corrosion
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Body weigh
The body weights of all rabbits were considered to be within the normal range of viability.
SKIN IRRITATION SCORE, individual results
ANIMAL NUMBER |
Sex |
Evaluation Interval * |
Erythema |
Oedema |
Scaling |
1 2 3 |
M F F |
1 hour |
2 1 1 |
0 0 0 |
0 0 0 |
1 2 3 |
M F F |
24 hour |
2 2 1 |
1 1 0 |
0 0 0 |
1 2 3 |
M F F |
48 hours |
2 2 1 |
1 1 0 |
0 0 0 |
1 2 3 |
M F F |
72 hours |
2 1 0 |
0 0 0 |
X 0 0 |
1 2 3 |
M F F |
7 days |
1 0 0 |
0 0 0 |
X 0 0 |
1 2 3 |
M F F |
10 days |
1 0 0 |
0 0 0 |
X 0 0 |
1 2 3 |
M F F |
14 days |
0 0 0 |
0 0 0 |
0 0 0 |
* Examination were performed at the specified times after the removal of the dressing.
X = Scaling present
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 February 2005 to 18 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, undiluted - Duration of treatment / exposure:
- one single instillation (0.1 mL/animal)
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3 (Animals of both sexes were used: 1 male + 2 females)
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane is considered to be "not irritanting" to the rabbit eye.
- Executive summary:
The primary eye irritation potential of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1ml into the left eye of three young adult New Zeland White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 and 10 days after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean score were 0.33, 0.33 and 0.00 for corneal opacity and 0.00 for the iris for all three animals, respectively. The individual mean scores for the conjunctivae were 1.33, 2.00 and 1.00 for redness and 0.33, 1.33 and 0.33 for chemosis, respectively.
The instillation of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane into the eye resulted in moderate, early onset and transient ocular changes, such as corneal opacity, reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 10 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
Thus the test item does not induce significant or irreversible damage to the rabbit eye.
Reference
Viability
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Irritation
The mean score was calculated across 3 scoring times mean (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.
Very slight corneal opacity affecting the whole area was noted in all animals at the 24 -hour observation and persisted in one female animal up to the 72 -hour reading.
Moderate reddening of the conjunctivae was noted in all animals from the 1 -hour to the 24 -hour observation and persisted in one female animal up to the 72-hour reading . Slight reddening was noted in two animals at the 48 -hour reading and was still present at the 72 -hour observation in the male animal.
Slight swelling (chemosis) of the conjunctivae was observed in all animals at the 1 -hour reading. Slight swelling to obvious swelling with partial eversion of lids was noted in all animals at the 24 -hour reading and slight swelling persisted in one female up to the 72 -hour reading.
Moderate reddening of the sclerae was present in all animals at the 1 -hour reading. Slight to moderate reddening was noted in all animals at the 24 -hour reading and in two animals at the 48 -hour reading. Slight erddening was noted in all animals at the 72 -hour reading and persisted in one animal up to the 7 -day reading.
Slight ocular discharge was noted in all animals from the 1 -hour to the 24 -hour observation.
Coloration
No staining of the treated eyes produced by the test item was observed.
Corrosion
No corrosion of the cornea was observed at any of the reading times.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
An in vivo study, performed in order to investigate the skin primary irritation potential of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane is reported. The study was performed according to OECD 404 guideline, based on a 4-hour semi-occlusive application. According to the conclusion of the study the substance is considered to be “not irritanting” to the rabbit skin.
An in vivo study, performed in order to investigate the eye primary irritation potential of 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane is reported. The study was performed according to OECD 405 guideline. According to the conclusion of the study the substance is considered to be “not irritanting” to the rabbit eye.
Justification for selection of skin irritation / corrosion
endpoint:
Available study, conducted under GLP and according to recognized
international standard guideline.
Justification for selection of eye irritation endpoint:
Available study, conducted under GLP and according to recognized
international standard guideline.
Justification for classification or non-classification
According to Regulation EC No. 1272/2008, 2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane does not meet the classification criteria for skin and eye irritation
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