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EC number: 202-896-0 | CAS number: 100-86-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 08-08-2017 to 22-02-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methyl-1-phenylpropan-2-ol
- EC Number:
- 202-896-0
- EC Name:
- 2-methyl-1-phenylpropan-2-ol
- Cas Number:
- 100-86-7
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-methyl-1-phenylpropan-2-ol
- Test material form:
- other: Colourless to slight yellow liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Yinghai (Cangzhou) Aroma Chemical Company Ltd./CP001-170601
- Expiration date of the lot/batch: June 1, 2018
- Purity: 99.7 % w/w
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 °C, ≤ 70 RH%), protected from humidity and light.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 4 hours (±10 min) at room temperature (23.4-24.6°C) covered with the plate lids.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Tissues were thoroughly rinsed with PBS solution to remove the test substance/controls.
- Observable damage in the tissue due to washing: without touching the epidermis
- Modifications to validated SOP: None
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: plate reader
- Wavelength: 570 nm - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL H2O
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 8N KOH - Duration of treatment / exposure:
- 4 hours (±10 min) at room temperature (23.4-24.6°C) covered with the plate lids.
- Number of replicates:
- 2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 minutes
- Value:
- 41.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: After three hours of incubation, yellow colour of the mixture was detected; therefore additional controls were not used in the experiment.
- Colour interference with MTT: As no coloured solution was detected and the test item had no intrinsic colour, no additional colour controls were needed in the experiment to determine the Non Specific Colour (the test item showed no ability to stain the epidermis).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD value of the two negative control tissues (0.843) was in the recommended range of 0.6 and 1.5.
- Acceptance criteria met for positive control: The two positive control treated tissues showed 0.6% viability, which is in the recommended range of 0 – 20%, demonstrating the proper performance of the assay.
- Acceptance criteria met for variability between replicate measurements:The difference of viability between the two negative control tissue samples in the MTT assay was 1.2% which meets the criteria not exceeding 30%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this in vitro EPISKIN™(SM) model test with dimethyl benzyl carbinol, the results indicate that the test item is non-corrosive to the skin.
- Executive summary:
In an in vitro skin corrosion assay in a human epidermal model EPISKINTM (SM) (17/236-039B), reconstructed human epidermis tissue was exposed to 50 µL of DMBC (99.7%) for 4 hours (±10 min). Physiological saline (0.9% (w/v) NaCl solution) was used for the negative control and glacial acetic acid was used for the positive control. After removal of the test substance, tissues were washed with PBS. Three hours incubation with MTT and an overnight isopropyl alcohol extraction period followed. The OD570 of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
The colour of the test substance did not interfere with the endpoint. The test substance is not directly MTT reducing. The average viability of tissues treated by the test substance DMBC was 41.4% compared to the negative control i.e. viability was > 35%. The average viability of tissues treated by the positive control was 0.6 % of negative control average value. According to these results, the test substance is not corrosive.
This in vitro skin corrosion study in the human epidermal model EPISKINTM (SM) is acceptable and satisfies the guideline requirement for an OECD 431 study.
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