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Diss Factsheets
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EC number: 460-230-6 | CAS number: -
- 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:
- 14 August 2012- 15 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (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
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): EP-4000S, Chemical name: Phenol, 4-4’-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and 2- methyloxirane
- Physical state: Light yellow liquid
- Analytical purity: 100%
- Lot/batch No.: 902Y1
- Expiration date of the lot/batch: 07 December 2012
- Storage condition of test material: Room temperature in the dark
Test animals / tissue source
- Species:
- other: bovine eyes
- Details on test animals or tissues and environmental conditions:
- The bovine eyes were excised and collected as soon after slaughter as possible (excised at 12.30 hours, 14 August 2012).
Excised eyes were maintained and transported to the laboratory, at ambient temperature, in sufficient HBSS, containing 1% (v/v) penicillin/streptomycin solution, to cover all the eyes in the receptacle.
The eyes were used within 4 hours of slaughter.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Concurrent positive and negative control corneas were examined
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): neat - Duration of treatment / exposure:
- 10 minutes (± 30 seconds)
- Observation period (in vivo):
- Following incubation, the positive and negative controls were removed and the epithelial surface of the cornea washed, at least three times or until the wash medium (EMEM with phenol red) was clear and there was no discolouration. The wash medium was added via the holes on the top of the holder. After each wash, the wash medium was removed using a pipette tip attached to a vacuum pump.
As the test substance, EP-4000S, was very viscous, it was not possible to remove using the vacuum pump. The anterior glass was removed and the corneas were gently washed with EMEM without phenol red until there was no discolouration of the wash medium. The anterior glass was then replaced.
Following completion of the two hour incubation period, the medium was removed from both compartments and replaced with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded.
The opacity values obtained at this stage were used in calculating the final In Vitro Irritancy Score.
Throughout the assay the corneas were examined for opaque spots or other irregularities. - Number of animals or in vitro replicates:
- Corneas were treated in triplicate with either the test substance, positive control (1% w/v sodium hydroxide) or negative control (0.9% sodium chloride solution).
- Details on study design:
- The assay uses isolated bovine corneas as a means of assessing the ocular corrosivity or severe irritancy potential of test substances in vitro.
The isolated corneas were obtained as a by-product of the meat production industry. Two endpoints, corneal opacity and permeability,
were measured and combined to give an In Vitro Irritancy Score.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Opacity
- Basis:
- mean
- Time point:
- other: 10 min
- Score:
- -0.333
- Remarks on result:
- other: SD=1.528
- Irritation parameter:
- other: Permeability OD 490
- Basis:
- mean
- Time point:
- other: 10min
- Score:
- -0.004
- Remarks on result:
- other: SD=0.013
- Irritation parameter:
- other: In Vitro Irritancy
- Basis:
- mean
- Time point:
- other: 10min
- Score:
- -0.4
- Remarks on result:
- other: In Vitro Irritancy Score (IVS) was calculated as: (Opacity +(15x Corrected OD 490)
- Irritant / corrosive response data:
- Throughout the assay the corneas were examined for opaque spots or other irregularities.
Following treatment with test substance, EP-4000S, the corneas were noted as clear. The corneas treated with the positive control, sodium hydroxide 1% (w/v), were very opaque and the corneas treated with the negative control, 0.9% saline, were clear.
Any other information on results incl. tables
The positive control, sodium hydroxide (1%), elicited an In Vitro Irritancy Score of 131.4.
This value was within the historical range (mean ± 2 x SD = 82.3 – 144.7) for the assays performed to date.
The negative control, 0.9% saline, opacity mean change value was 1.0 which was below the maximum acceptance value of 2.0.
The permeability mean of the negative control was 0.028 which was below the maximum acceptance value of 0.1.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, EP-4000S, elicited an In Vitro Irritancy Score of -0.4 ± 1.7 and was predicted to be a non-corrosive/ non-severe eye irritant.
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