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Diss Factsheets
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EC number: 700-678-4 | CAS number: 1076-12-6
- 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:
- 15 November 2011 to 21 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1R,2R,3S,6R,7S,8S)-tetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene
- EC Number:
- 700-678-4
- Cas Number:
- 1076-12-6
- Molecular formula:
- C12H16
- IUPAC Name:
- (1R,2R,3S,6R,7S,8S)-tetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene
- Details on test material:
- - Name of test material (as cited in study report): TCD
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Organic
- Physical state: Clear Liquid
- Analytical purity: ca 100%
- Lot/batch No.: M0904
- Expiration date of the lot/batch: 31 December 2013
- Storage condition of test material: Refigerated in the dark
Constituent 1
In vitro test system
- Test system:
- human skin model
Test animals
- Species:
- other: EPISKIN three-dimensional human skin model
- Details on test animals or test system and environmental conditions:
- The test involves the application of the test substance for 15 minutes to the EPISKIN three dimensional human skin model. The model consists of normal, human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen. After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum has formed. The epidermis surface area supplied is 0.38cm2. The EPISKIN kits include assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar.
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ?l of the test substance was dispersed over each tissue using a positive displacement pipette - Observation period:
- Each insert was incubated for 42±1 hour at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. After 42 ± 1 hour each insert was transferred to a well containing 2 ml of 0.3 mg/ml MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
- Number of animals:
- Triplicate tissues each for test substance, negative control (sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium) and positive control (5% Sodium Dodecyl Sulphate (SDS) in distilled water)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 36.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- There was no change in the test substance, TCD/MTT solution or the water control/MTT solution after three hours incubation in the dark at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. The test substance had not interacted with the MTT.
The test substance, TCD/water solution and water control were colourless after the 15 minute shaking period. The test substance, TCD, had not shown any potential for colouring water.
The pH of the test substance, when diluted to 10% v/v with distilled water, was approximately 7.0 when measured using pH indicator paper.
Any other information on results incl. tables
Negative Control
The mean absorbance of the triplicate negative control values was 0.811 which was between the minimum and maximum values of 0.6 and 1.5. The standard deviation (SD) of the % viability was 2.6 which was below the maximum value of 18.
Positive control
The percentage mean viability of the positive control was 11.7 ± 6.4 of the negative control. These were below the maximum acceptance values of 40% viability and SD of 18.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- It was concluded that the test substance, TCD, with a mean tissue viability of 36.1± 15.4%, was predicted as irritant to the skin.
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