Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-467-3 | CAS number: 121-39-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 March 2000 - 01 April 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Information is used for read across to Ethylphenylglycidate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- EC Number:
- 201-061-8
- EC Name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- Cas Number:
- 77-83-8
- Molecular formula:
- C12H14O3
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Littlerussian from BI Pharma KG, 88397 Biberach
- Age at study initiation: No data.
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: Individually in PPO cages with perforated floor.
- Diet: Free access to pelleted complete rabbit diet (Altromin 2123" from Altromin, D-32791 Lage, Lippe)
- Water: Free access to quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: No data.
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as control.
- Amount / concentration applied:
- Amount applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single instillation on Day 1
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- STUDY DESIGN
The test material was applied undiluted in 4 animals.
TREATMENT
In accordance with OECD 405. The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.
REMOVAL OF TEST SUBSTANCE
-Washing: Yes, 24 hours after instillation of the test substance.
OBSERVATIONS
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
SCORING SYSTEM:
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.
TOOL USED TO ASSESS SCORE: After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: animal #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- other: animal #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: animal #1, #2 and #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after application of the test article animal #1 showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal. In animal #2 were observed some conjunctival vessels definitely injected, a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids. The animal #3 showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. In animal #4 were observed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids.
24 hours after application of the test article in animals #1, #2 and #4 were observed some conjunctival vessels definitely injected and a swelling above normal. Animal #3 showed some conjunctival vessels definitely injected.
48 hours after application of the test article all four animals were free of any signs of eye irritation.
72 hours after application of the test article all four animals were free of any signs of eye irritation, too.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant.
- Remarks:
- According to EU CLP Regulation (EC) No. 1272/2008 and its amendments
- Conclusions:
- In an eye irritation study with 4 rabbits, performed according to OECD 405 guideline and GLP principles, all rabbits had slight reddening of the conjuctivae observed at 24 hours only. Three rabbits showed also showed slight chemosis at 24 hours only. All signs of irritation were reversible within 48 hours, the substance is not an eye irritant.
- Executive summary:
The substance was tested in an eye irritation test in 4 rabbits according to OECD TG 405 test guideline and GLP principles. All rabbits had slight reddening of the conjuctivae observed at 24 hours only. Three rabbits also showed slight chemosis at 24 hours only. All signs of irritation were reversible within 48 hours, the substance is not an eye irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.