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EC number: 943-286-0 | CAS number: 955359-35-0
- 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:
- 2016-11-21 to 2017-03-09
- 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:
- 2017
Materials and methods
Test guidelineopen allclose all
- 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)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MaTTek Corporation: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals
- Version / remarks:
- 29 Hune 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- R,R-1-(4-tert-butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- R,R-1-(4-tert-butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Reference substance name:
- R,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- R,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Reference substance name:
- S,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- S,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Reference substance name:
- S,R-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- S,R-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Test material form:
- solid
- Details on test material:
- Minimum purity 95% w/w
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Name: Art. 132720 (RonaCare Pristine Bright)
Synonym: Avodiol
CAS-No.: 955359-35-0
Batch: EH16000620
Purity: 95 % (w/w) (HPLC)
Appearance: light cream, free flowing granules
Released until: 2018-06-30
PREPARATION OF THE TEST MATERIAL
The test item Art. 132720 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- CELL CULTURE
- Supplier: MatTek Corporation (82105 Bratislava, Slovakia)
- Source: human epidermal keratinocytes cultured to form a stratified squamous epithelium
- Format: 24 well plate
- Batch: 23757
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: 37°C
- Temperature of post-treatment incubation: 37°C
REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST ITEM: 50 mg
NEGATIVE CONTROL: 50 µL (deionised water)
POSITIVE CONTROL: 50 µL (methyl acetate) - Duration of treatment / exposure:
- 6 h
- Number of animals or in vitro replicates:
- duplicate
- Details on study design:
- According to guideline
Results and discussion
In vitro
Results
- Irritation parameter:
- other: cell viability
- Run / experiment:
- mean value
- Value:
- 3.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Group | Time / [h] | Mean Absorbance | Mean Relative viability / [%] |
Negative Control | 6 | 1.355 | 100 |
Positive Control | 6 | 0.247 |
18.2 |
Test Item |
6 |
0.044 |
3.3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses an eye irritating potential.
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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