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Diss Factsheets
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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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- 2,2-Difluoroethyl acetate
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- 2,2-Difluoroethyl acetate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
ASSESSMENT FOR THE SUBSTANCE ITSELF - 2,2-DIFLUOROETHYL ACETATE
Persistence: The available screening degradation data on ready biodegradation, inherent biodegradation and hydrolysis do not allow ruling out persistence. It was thus decided to regard 2,2-Difluoroethyl acetate as being persistent (P) and very persistent (vP).
Bioaccumulation: 2,2-Difluoroethyl acetate is not B and not vB based on a log Kow ≤ 4.5 (Log Kow = 0.45 at 20 °C).
Toxicity: 2,2-Difluoroethyl acetate is not T based on:
- Long-term EC10/NOEC ≥ 0.01 mg/L for fish (32d-NOEC ≥ 9.54 mg/L in Gobiocypris rarus), daphnids (21d-NOEC = 4.68 mg/L in Daphnia magna) and algae (72h-NOErC ≥ 80.6 mg/L in Pseudokirchneriella subcapitata).
- The absence of classification as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008.
- The absence of other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.
To be regarded as PBT, a substance has to fulfill the three criteria (i.e. P and B and T). Similarly, to be regarded as vP/vB, a substance has to fulfill both criteria (i.e. vP and vB). 2,2-Difluoroethyl acetate does not meet the B/vB and T criteria and therefore is neither PBT, not vP/vB.
ASSESSMENT FOR THE HYDROLYSIS PRODUCTS
As described in the study reports dealing with hydrolysis (see IUCLID section 5.1.2) and ready biodegradability (see IUCLID section 5.2.1), acetic acid, difluoroacetic acid and 2,2-difluoroethanol are products resulting from the transformation pathway of 2,2-Difluoroethyl acetate. According to ECHA Guidance R.11 (v.3.0, June 2017), indications that transformation products are formed should be addressed either qualitatively or quantitatively. This was done on the basis of the information available on these three hydrolysis products:
- Acetic acid was concluded to be not P/not vP, not B/not vB and not T, and as a consequence is neither PBT, nor vP/vB.
- Difluoroacetic acid was concluded to be not P/not vP, not B/not vB and not T, and as a consequence is neither PBT, nor vP/vB.
- 2,2-difluoroethanol was concluded to be P but not vP and not B/not vB. Even in the absence of data to assess the T criterion, it can already be concluded that 2,2-difluoroethanol is not PBT or vP/vB, the B/vB and vP criteria being not fulfilled.
Reference
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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