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EC number: 801-773-4 | CAS number: 1550-44-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27 JUNE 2013 to 19 AUGUST 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-difluoroethyl acetate
- EC Number:
- 801-773-4
- Cas Number:
- 1550-44-3
- Molecular formula:
- C4H6F2O2
- IUPAC Name:
- 2,2-difluoroethyl acetate
- Test material form:
- liquid
- Remarks:
- clear and colorless.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino.
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: animals were received from Robinson Services, Inc. Mocksville, NC, USA.
- Sex: female, nulliparous and non-pregnant.
- Age at study initiation: young adult.
- Weight at study initiation: the initial weight ranged from 2131 g to 2371 g, see Table 1 below in section "Any other information on results incl. tables".
- Housing: the animals were individually housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g. toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: filtered tap water was supplied ad libitum.
- Acclimation period: 6 or 13 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 22°C.
- Humidity: 64 - 77%. The humidity was above the targeted upper limit for four days during the study. A portable dehumidifier was used to lower the humidity levels during this time.
- Air changes (per hr): 12. Airflow measurements were evaluated regularly.
- Photoperiod: 12 hour light/dark cycle.
IN-LIFE DATES: From 2 July 2013 to 12 July 2013.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- Approximately 24 hours prior to application, the animals were prepared by clipping the dorsal area and the trunk.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Five-tenths of a millilitre of the undiluted test material was applied.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- The observation period lasted up to 72 hours after patch removal.
- Number of animals:
- 3 animals.
Initially, only one rabbit was placed on test. Since no dermal irritation was observed at the dose site on this animal, the test was completed with two additional rabbits. - Details on study design:
- TEST SITE
- Area of exposure: the test substance was applied to one 6-cm2 intact dose site on each animal.
- Type of wrap: After application of the test substance, the dose site was covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk of each animal were wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit.
REMOVAL OF TEST SUBSTANCE
- Washing and time after start of exposure: After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.
OBSERVATION TIME POINTS
Individual dose sites were scored immediately following patch removal (initial rabbit only) and at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal.
SCORING SYSTEM:
- Method of calculation: Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since there was no effect.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since there was no effect.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since there was no effect.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since there was no effect.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since there was no effect.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since there was no effect.
- Irritant / corrosive response data:
- There was no dermal irritation observed at any treated dose site during the study. See more details in "Any other information on results incl. tables" below.
- Other effects:
- - Body weight: All animals gained body weight during the study. See more details in Table 1 in the field "Any other information on results incl. tables".
- Clinical signs: All animals appeared active and healthy during the study. There were no clinical signs observed.
Any other information on results incl. tables
Table 1: Individual body weights
Animal No. | Sex | Body Weight (g) | |
Initial | Terminal | ||
3501 | F | 2219 | 2350 |
3502 | F | 2371 | 2599 |
3503 | F | 2131 | 2170 |
Table 2: Individual skin irritation scores: erythema / edema
Animal No. | Sex | Time After Patch Removal
| ||||
Immediately after patch removal | 30-60 mins | 24 hrs | 48 hrs | 72 hrs | ||
3501 | F | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 |
3502 | F | N/A | 0/0 | 0/0 | 0/0 | 0/0 |
3503 | F | N/A | 0/0 | 0/0 | 0/0 | 0/0 |
N/A – Not Applicable
Table 3: Summary of mean scores for dermal responses
Rabbit No. | Erythemaa | Edemaa |
3501 | 0.0 | 0.0 |
3502 | 0.0 | 0.0 |
3503 | 0.0 | 0.0 |
a Calculated from the 24, 48 and 72-hour dermal responses.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, 2,2-Difluoroethyl acetate did not induce dermal irritation in rabbits.
- Executive summary:
The skin corrosion/irritation potential of 2,2-Difluoroethyl acetate was investigated in a study performed according to OECD test guideline 404 under GLP compliance.
The study was carried out with three female New Zealand albino rabbits. Approximately 24 hours prior to application, the animals were prepared by clipping the dorsal area and the trunk. Initially, one rabbit was treated as follows: 0.5 mL of the test substance was applied to one 6-cm2 intact dose site and covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collar was placed and the rabbit was returned to its cage. After an exposure period of 4 hours, the pad and collar were removed. Dose site was scored according to the Draize scoring system (Draize et al., 1944) immediately following patch removal and at approximately 30-60 minutes, 24, 48, and 72 h after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.
No clinical signs of toxicity were observed in the study. None of the three rabbits tested showed dermal irritation at the treated dose site.
Under the conditions of this study, 2,2-Difluoroethyl acetate did not induce dermal irritation in rabbits.
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