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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- FROM 31 AUGUST 2015 TO 21 NOVEMBER 2015.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: the animals were approximately 9 weeks old on the day of dosing.
- Weight at study initiation: female weight was in the range 211.2 - 228.3 g and male weight was in the range 318.4 - 346.7 g.
- Fasting period before study: no.
- Housing: animals were housed individually in solid-bottom caging with bedding and appropriate species specific enrichment.
- Diet: the rats were fed PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 ad libitum.
- Water: all rats were provided tap water ad libitum.
- Acclimation period: the rats were weighed and observed for general health during the 7-day quarantine period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C.
- Humidity (%): 30-70%.
- Photoperiod: animal rooms were artificially illuminated (fluorescent light) on an approximate12-hour light/dark cycle.
IN-LIFE DATES: From: 10 September 2015 To: 24 September 2015.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 5 cm x 7.4 cm.
- Preparation of animals for exposure and application conditions: approximately 24 hours before dosing, the fur of each rat was closely shaved to expose the back from the scapular to the lumbar region. The test substance was inverted to mix before the dosing procedure. An aliquot of test substance was spread evenly, directly on the skin, covering an area of approximately 37 square centimetres. The rats were reshaved as needed during the study.
- % coverage: approximately 10% of the total body surface.
- Type of wrap if used: the test material was covered with a 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage. .
REMOVAL OF TEST SUBSTANCE
- Washing and time after start of exposure: approximately 24 hours after treatment, the
wrappings were removed. Excess test material was washed from the dorsal skin of each rat with paper towels soaked in warm water, and the skin was dried.
TEST MATERIAL
- Amount(s) applied and concentration: the amount of neat test material designated for each animal was calculated based on body weights collected prior to treatment and the test material density of 1210 mg/mL, to obtain a dose level of 5000 mg/kg bw. - Duration of exposure:
- 24 hrs.
- Doses:
- 5000 mg/kg bw (males and females).
- No. of animals per sex per dose:
- 5 males and 5 females.
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: the rats were observed for clinical signs prior to and after dosing, immediately after wrapping removal/washing and then daily. Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, abnormal behavior. The rats were weighed on test days 1, 8, and 15.
- Necropsy of survivors performed: yes. All rats were euthanized at the end of the 15-day test period by exsanguination while under isoflurane anesthesia and examined to detect grossly observable evidence of organ or tissue damage.
- Other examinations performed: Dermal effects were scored according to the Draize Scale immediately after wrapping removal/washing. The rats were observed daily for dermal irritation (weekends and holidays excluded). - Statistics:
- Not relevant for that study.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no instances of mortality.
- Clinical signs:
- salivation
- Body weight:
- other body weight observations
- Remarks:
- There were no overall (test day 1-15) body weight losses among any animals.
- Gross pathology:
- No gross lesions were present in the rats at necropsy.
- Other findings:
- Skin responses:
At the beginning of the observation period (approximately 24 hours after exposure), on test day 2, erythema (with a score of 1) was observed in one male, which was resolved by test day 3. There were no instances of edema observed. A scab on the back was observed in one male between test days 4-6 and in one female between test days 4-5.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the dermal LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg in male and female rats.
- Executive summary:
The acute dermal toxicity of 2,2-Difluoroethyl acetate was investigated in a study performed according to OECD test guideline 402 under GLP compliance.
A single dose of 5000 mg/kg bwt was applied neat to the shaved, intact skin of five male and five female Crl:CD(SD) rats. The application site was covered with a semi-occlusive dressing for 24 h, after which the test substance was removed. The observation period lasted 14 days following application. All rats were observed for mortality, body weight effects, clinical signs and dermal response (according to the Draize scale, Draize et al. 1944). On day 15, the rats were necropsied to detect grossly observable evidence of organ or tissue damage.
There were no instances of mortality. A scab on the back was observed in one male, between days 4-6 and in one female, between days 4-5. Salivation was observed in one male on day 1 during the exposure period, which was likely a reaction to the wrapping procedure. No other clinical abnormalities were observed. At the beginning of the observation period (approximately 24 h after exposure), on day 2, erythema (with a score of 1) was observed in one male, which was resolved by day 3. There were no instances of edema observed. There were no overall (days 1-15) body weight losses among any animals. No gross lesions were present in the rats at necropsy.
Under the conditions of this study, the acute dermal LD50 value of 2,2-Difluoroethyl acetate was determined to be greater than 5000 mg/kg bwt in male and female rats.
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