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Diss Factsheets
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EC number: 210-288-1 | CAS number: 611-99-4
- 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:
- 6h exposure on the surface of EpiOcularTM reconstructed ocular epithelium and 18h post-incubation time
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-dihydroxybenzophenone
- EC Number:
- 210-288-1
- EC Name:
- 4,4'-dihydroxybenzophenone
- Cas Number:
- 611-99-4
- Molecular formula:
- C13H10O3
- IUPAC Name:
- 4,4'-dihydroxybenzophenone
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity >99.5%w/w
Constituent 1
- Specific details on test material used for the study:
- Batch number: 20160804
Purity: 100%
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The EpiOcularTM tissue model (OCL-200 - MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Method of administration of test and reference items:
After pre-wetting tissues with 20μl PBS (Sterile Dulbecco’s Phosphate Buffered Saline) for 30 ± 2 min, single topical application of neat test item to the surface of the EpiOcularTM model; three tissues per condition (n=3). - Duration of treatment / exposure:
- Exposure times of test and reference items:
Single application of a levelled spoonful (designed to hold approximately 50mg) of test item or 50μl of reference items topically on tissues for 6 hours ± 15 minutes, followed by a 25 ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation, prior to the MTT endpoint
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Percentage of viability (relative to negative control)
- Value:
- 59.982
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item DHB - 4,4’-dihydroxybenzone phenone reduced the viability below 60% of the negative control value after 6h of application and should be considered as Irritant to the eye.
The percentage of viability obtained with test item DHB - 4,4’-dihydroxybenzone phenone was 59.982 %, therefore it has to be considered as Irritant to the eye. However, it should be noticed that the viability result is very close to the threshold of 60%.
Any other information on results incl. tables
Interpretation of results following Prediction Model
A test item is considered to be irritant to the eye (i.e. would require labelling as either GHS 1 or 2) if the eye model viability after exposure and post-treatment incubation is ≤60%.
A test item is considered as a non-irritant to the eye (i.e. would not require a warning label in the European chemical classification systems) if the eye model viability after exposure and post-treatment incubation is >60%.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this study, the eye irritation potential of DHB - 4,4'-dihydroxybenzone phenone was assessed in vitro according to OECD Test Guideline 492 (Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage).
After 6h exposure on the surface of EpiOcularTM reconstructed ocular epithelium and 18h post-incubation time, the viability of the tissues was assessed and compared to a negative control.
The percentage viability obtained was 59.982% and therefore: DHB - 4,4'-dihydroxybenzone phenone was classified as an Irritant to the human eye.
However, because the result obtained was very close to the limit below which classification would not be required, the lower Category 2 classification has been applied as being the most appropraite in the absence of further test results.
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