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EC number: 223-225-8 | CAS number: 3775-29-9
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Jul 2017 - 27 Jul 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methylenepropane-1,3-diyl diacetate
- EC Number:
- 223-225-8
- EC Name:
- 2-methylenepropane-1,3-diyl diacetate
- Cas Number:
- 3775-29-9
- Molecular formula:
- C8H12O4
- IUPAC Name:
- 2-[(acetyloxy)methyl]prop-2-en-1-yl acetate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 20160308(-88)
- Expiration date of the lot/batch:
- Physical Appearance: clear colourless liquid
- Purity: 99.7%
- Storage: room temperature in the dark
- Expiration date: 31 Mar 2019
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: local abattoir
- Number of animals: 3
- Characteristics of donor animals - age: 12 – 60 months
- Storage, temperature and transport conditions of ocular tissue: eyes were excised after slaughter, placed in HBSS supplemented with penicillin (100 IU/ mL and streptomycin at 100µg/ mL), transported to the test facility over packs of ice on the same day of slaughter. Corneas prepared immediately on arrival. Isolated corneas were mounted in BCOP holders which were filled with EMEM without phenol red and incubated at 32 ± °C for 60 min.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 120 min at 32°C ±1°C
- Number of animals or in vitro replicates:
- 3 per control group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Eyes were excised after slaughter, placed in HBSS supplemented with penicillin (100 IU/ mL and streptomycin at 100µg/ mL), transported to the test facility over packs of ice on the same day of slaughter. Corneas prepared immediately on arrival. Isolated corneas were mounted in BCOP holders which were filled with EMEM without phenol red and incubated at 32 ± °C for 60 min.
QUALITY CHECK OF THE ISOLATED CORNEAS
Each cornea was examined, only corneas free of damage were used.
NUMBER OF REPLICATES:
3 per control group
NEGATIVE CONTROL USED
Identification: Sodium Chloride 0.9% w/v
Batch: 3011424
Purity: 0.9%
Expiry Date: 01 Jan 2017
Storage: room temperature in the dark
POSITIVE CONTROL USED
Identification: Ethanol
Batch: STBD7546V
Purity: >99.8%
Expiry Date: 01 Apr 2018
Storage: room temperature in the dark
APPLICATION DOSE AND EXPOSURE TIME
0.75ml, undiluted, applied under safety lightening, exposure for 10 min.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
After exposure time the test item and the control item were removed from the anterior chamber and the each cornea was rinsed 3 times with fresh EMEM containing phenol red before a final rinse with complete EMEM without phenol red.
- POST-EXPOSURE INCUBATION: The BCOP holders were incubated, anterior chamber facing forward, at 32 ± 1° for 120 min.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: optical density 492nm (OD492) was measured using the Anthos 2001 microplate reader.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
In Vitro Irritancy Score = mean opacity value + (15 x mean permeability OD492 value)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean test item
- Value:
- 8.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean negative control
- Value:
- 2.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean positive control
- Value:
- 42.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- No prediction of eye irritation can be made.
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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