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Diss Factsheets
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EC number: 600-704-3 | CAS number: 10597-60-1
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 31st 2021 to June 11th 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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
Test material
- Reference substance name:
- 4-(2-hydroxyethyl)benzene-1,2-diol
- EC Number:
- 600-704-3
- Cas Number:
- 10597-60-1
- Molecular formula:
- C8H10O3
- IUPAC Name:
- 4-(2-hydroxyethyl)benzene-1,2-diol
1
- Specific details on test material used for the study:
- Off white to light yellow powder
Stability 5 years
Expiration date 15/08/23
Batch NM20180815
Test animals / tissue source
- Species:
- other: reconstructed epithelium by airlifted culture of transformed human corneal keratinocytes
- Details on test animals or tissues and environmental conditions:
- - Cell line used, its source, passage number and confluence of cells used for testing: Epithelium consisting of viable layers of cells including columnar basal cells, transitional wing cells and superficial squamous cells
- RhCE tissue or hCE cell construct used, including batch number: EPIskin Batch 21-HCE-038
- For hCE cell: passage number and confluence of cells used, time and date of sub-culturing, duration of tripsinization, dilution ratio: Number of cell layers (5.5 cell layers)
Test system
- Vehicle:
- water
- Remarks:
- distilled water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required): NM20180815
- Purity: 100% - Duration of treatment / exposure:
- The HCE tissues were exposed to controls and sample/s in duplicate, for 30 minutes (liquids) or for 4 hours (solids) at 37ºC.
- Duration of post- treatment incubation (in vitro):
- After treatment, a post-exposure immersion is carried out in fresh medium for 30 minutes at 37ºC (liquids) or at room temperature (solids), to remove any remaining sample absorbed in
the tissue. Furthermore, in the case of solid samples, an 18-hour post-immersion incubation
step is carried out at 37ºC - Number of animals or in vitro replicates:
- Duplicate
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Value:
- ca.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The value of the tissues treated with the sample for the interaction test presents a lower value than
the interaction control tissues, so it is considered that the sample has no interaction with MTT.
In addition, the value of the tissues treated with the sample for the interaction test and the value of the tissues treated with the test sample is very similar, therefore it is confirmed that there is no
interaction with MTT. - Executive summary:
The classification of the sample tested at 2% is "No Category". If there are no statistically significant differences between sample and Negative Control, it is considered that the sample acts the same as the Control of the test and it can be clasify as "Non-irritant"
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