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Diss Factsheets
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EC number: 201-061-8 | CAS number: 77-83-8
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.008 mg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.084 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 8.4 µg/L
- Assessment factor:
- 5 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.214 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.021 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.038 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 23.3 mg/kg food
- Assessment factor:
- 30
Additional information
Freshwater aquatic organisms
Short-term aquatic toxicity data are available for each of the three freshwater trophic levels (fish, daphnia and algae). The observed L(E)C₅₀ values were:
96-hour LC₅₀ for freshwater rainbow trout (Oncorhynchus mykiss) = 4.2 mg/L
48-hour EC₅₀ for freshwater invertebrate (Daphnia magna) = 52 mg/L
72-hour growth rate EC₅₀ (ECr₅₀) for freshwater algae (Pseudokirchneriella subcapitata) = 36 mg/L
When only short-term toxicity data are available, an assessment factor of 1000 is typically applied on the lowest L(E)C₅₀ to derive a PNEC for freshwater. The lowest L(E)C₅₀ is the fish 96-hour LC₅₀ of 4.2 mg/L. However, due to animal welfare reasons in this study (Harlan 41104030) fish that were considered likely to die (e.g. moribund or suffering severe sub-lethal effects) were humanely killed and classed as mortalities for the following observational timepoints.
Introduction of the moribund category to the OECD fish acute test has been shown to lower the median lethal concentration (LC₅₀) derived on fish declared as moribund compared to conventional LC₅₀ values (Rufli 2012). Based on the results of the Rufli study, the assessment factors for LC₅₀moribund may, on average, be lowered by a factor of 2 to set safe concentrations. Thus for derivation of PNECaquatic an assessment factor of 500 instead of the standard 1000 has been adopted.
PNEC secondary poisoning was derived from the available information on a 2 year repeated dose toxicity. The NOAEL of 35 mg/kg bw/day (chronic, rat) was converted to concentration (NOEC) by multiplying by a factor of 20 (based on age of rats, > 6 weeks) and by applying an assessment factor of 30 (based on the duration of the study) as described in Guidance R.10 8. For Soil and sediment PNECs, wet weight PNECs were calculated with using equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6 (1.13 soil).
Conclusion on classification
Ethyl 2,3-epoxy-3-phenylbutyrate is classified as R51/53 according to Directive 67/548/EEC (DSD) and Aquatic Chronic 2 (H411) according to Regulation 1272/2008/EC and Adaptation 286/2011/EC (CLP) based on the 96 hr fish LC₅₀ which is > 1 to ≤ 10 mg/L, and the fact that the substance is not "rapidly biodegradable" in the aquatic environment.
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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