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Diss Factsheets
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EC number: 267-032-7 | CAS number: 67762-73-6
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 February 2016 to 22 February 2016
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized
- EC Number:
- 267-032-7
- EC Name:
- Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized
- Cas Number:
- 67762-73-6
- IUPAC Name:
- Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): EXP1506833
- Physical state: amber coloured viscous liquid
- Storage condition of test material: room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E00350-290
- Expiration date of the lot/batch: 23 June 2019
- Purity test date: 58 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN reconstructed human epidermis
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKINTM Reconstructed Human Epidermis Model Kit
Supplier: SkinEthic Laboratories, Lyon, France
Date received: 16 February 2016
EpiSkinTM Tissues (0.38cm²) lot number: 16-EKIN-007
Maintenance Medium lot number: 16-MAIN3-009
Assay Medium lot number: 16-ESSC-007 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL (26.3 µL/cm²)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL Dulbecco’s Phosphate Buffered Saline with Ca++ and Mg++
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL Sodium Dodecyl Sulphate
- Concentration (if solution): 5 % w/v aqueous solution - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Triplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Relative mean
- Value:
- 110.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 113
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 106.4
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 113.3
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The MTT solution containing the test item did not turn blue which indicated that the test item did not directly reduce MTT.
- Colour interference with MTT: The solution containing the test item was colourless, it was therefore unnecessary to run color correction tissues.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: YES
- Acceptance criteria met for positive control: YES
- Acceptance criteria met for variability between replicate measurements: YES
Any other information on results incl. tables
Mean OD562 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD562 of tissues | Mean OD562 of triplicate tissues | ±SD of OD562 | Relative individual tissue viability (%) | Relative mean viability (%) | ±SD of relative mean viability |
Negative Control Item | 0.865 | 0.845 | 0.024 | 102.3 | 100* | 2.8 |
0.819 | 96.9 | |||||
0.852 | 100.8 | |||||
Positive Control Item | 0.063 | 0.071 | 0.012 | 7.5 | 8.4 | 1.3 |
0.065 | 7.7 | |||||
0.084 | 9.9 | |||||
Test Item | 0.955 | 0.937 | 0.033 | 113.0 | 110.9 | 3.9 |
0.899 | 106.4 | |||||
0.957 | 113.3 |
*=The mean viability of the negative control tissue is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The relative mean tissue viability calculated as a percentage of the negative control was 110.9 % after the 15-minute exposure followed by the 42-hour post exposure. The test substance did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
The in vitro skin irritation of the test substance was determined in accordance with the OECD Testing Guideline 439. The purpose of this test was to evaluate the skin irritation potential of the registered substance using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item by means of the colorimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the registered substance treated tissues relative to the negative controls.
Triplicate tissues were treated with the registered substance for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labeled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density was measured at 562 nm. Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean tissue viability calculated as a percentage of the negative control was 110.9 % after the 15-minute exposure followed by the 42-hour post-exposure. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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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