Registration Dossier
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EC number: 609-946-4 | CAS number: 41637-38-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From August 16 to 25, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted similarly to OECD Guideline 405 with minor deviations: individual animal weights not reported
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- individual animal weights not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 64401-02-1
- Cas Number:
- 64401-02-1
- IUPAC Name:
- 64401-02-1
- Reference substance name:
- Bisphenol A ethoxylated diacrylate
- IUPAC Name:
- Bisphenol A ethoxylated diacrylate
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Hampshire, England
- Age at study initiation: Approximately 10-13 weeks
- Weight at study initiation: 2.3-3.1 kg
- Housing: Housed individually in metal cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- no washing was done
- Observation period (in vivo):
- 7 days
- Examination of the eyes was made after 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h after instillation), 4 and 7 days after instillation. - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize (1977) scoring system
TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- - No corneal damage or iridial inflammation was observed.
- Temporary mild conjunctival reactions only were seen.
- Eyes were normal one day after instillation. - Other effects:
- - No signs of toxicity were observed in any animal throughout the observation period.
Any other information on results incl. tables
Table 1: Ocular reactions observed after instillation of Bisphenol A ethoxylated diacrylate
Rabbit number and sex
| Region of eye
| 1 h | Day after instillation | |||||
1 | 2 | 3 | 4 | 7 | ||||
2293 * (Female) | Cornea
| 0 | 0 | 0 | 0 | 0 | 0 | |
Iris
| 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjunctiva
| Redness
| 1 | 0 | 0 | 0 | 0 | 0 | |
Chemosis
| 1 | 0 | 0 | 0 | 0 | 0 | ||
2294 (Female) | Cornea
| 0 | 0 | 0 | 0 | 0 | 0 | |
Iris
| 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjunctiva
| Redness
| 1 | 0 | 0 | 0 | 0 | 0 | |
Chemosis
| 1 | 0 | 0 | 0 | 0 | 0 | ||
2295 (Female) | Cornea
| 0 | 0 | 0 | 0 | 0 | 0 | |
Iris
| 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjunctiva
| Redness
| 1 | 0 | 0 | 0 | 0 | 0 | |
Chemosis
| 1 | 0 | 0 | 0 | 0 | 0 |
* Pilot animal
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an eye irritation study conducted similarly to the OECD Guideline 405 and in compliance with GLP, 3 healthy female rabbits of the New Zealand White strain were exposed to 0.1 mL of Bisphenol A ethoxylated diacrylate in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h), 4 and 7 days after instillation and graded according to the method of Draize (1977).
No corneal damage or iridial inflammation was observed. Temporary mild conjunctival reactions only were seen. All the eyes were normal one day after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score. In this study, Bisphenol A ethoxylate diacrylate is not an eye irritant on female rabbits.
Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
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