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EC number: 700-736-9 | CAS number: 2149571-40-2
- 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:
- 03 April 2013 to 09 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD guidelines and in compiance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Certificate of Compliance from UK GLP Monitoring Authority included in report.
Test material
- Reference substance name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- EC Number:
- 700-736-9
- Cas Number:
- 2149571-40-2
- Molecular formula:
- C14H14
- IUPAC Name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- Details on test material:
- - Name of test material (as cited in study report): MTF
- Substance type: Organic
- Physical state: Transparent Liquid
- Analytical purity: ca 100%
- Lot/batch No.: M1204
- Expiration date of the lot/batch: 31 December 2015
- Storage condition of test material: Room temperature (ca. 20 deg C)
- Other:
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN TM human epidermis skin constructs.
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
On receipt, the EPISKINTM kit contents were checked and the inserts with tissues on agar were stored at room temperature until use. Procedures requiring viable tissues, dosing,
42 hour incubation and incubation with MTT were conducted within the expiry date indicated by the supplier (expiry date: 08 April 2013). The maintenance medium was pre-warmed to
37ºC. The tissues were removed from the agar and placed into wells of 12 well plates containing 2 mL pre-warmed maintenance medium per well. The tissues were incubated for
a minimum of 24 hours at 37° +/- 2°C in a humidified atmosphere of 5% CO2 in air.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37° +/- 2°C
After incubation of at least 24 hours in maintenance medium, triplicate tissues were dosed for minutes with the test substance, negative or positive control at room temperature.
A maximum of four samples were applied in a block with a minimum of 1 minute intervals between each application of substance. The test substance, MTF, was spread over the
surface of the tissue using a curved spatula. On application of 10 microL, the positive control was spread over the tissue for approximately 30 seconds and then respread with a curved flat
spatula after 7 minutes application time.
After 15 minutes, each tissue was rinsed with 25 mL sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance. Tissues treated with test
substance, MTF, were gently swabbed to remove remaining test material. Inserts were then blotted on absorbent paper to remove remaining DPBS. Each insert was then transferred to a
well containing 2 mL maintenance medium and incubated for 42 hour at 37°C in a humidified atmosphere of 5% CO2 in air.
After 42 hours , each insert was transferred to a well containing 2 mL of 0.3 mg/mL MTT and incubated for 3 hours at 37°C in a humidified atmosphere of 5% CO2 in air.
At the end of 3 hours, all the inserts were blotted on absorbent paper. The tissue was removed from the insert using a biopsy punch and the epidermis was separated from the
collagen matrix using forceps. The epidermis and the collagen matrix were placed together in a micro tube.
When all the tissues had been punched, the tissues (epidermis and collagen matrix) were vortexed with 500 μL of acidic isopropanol (0.04 N HCl final concentration) to solubilize and
extract the formazan product. The formazan product was extracted from the tissues by storing at 2-8 ºC, protected from light, for 48 - 70 hours.
After formazan extraction, duplicate 200 microlitre aliquots of the extractant from each micro tube were pipetted into the wells of flat-bottomed 96-well plates. The extractant was mixed by
vortexing prior to taking the aliquots. The absorbance was read at 540 nm, with six wells containing acidified isopropanol (0.04 N HCl final concentration) as a blank.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Duration of treatment / exposure:
- Triplicate tissues were dosed for 15 +/- 0.5 minutes with the test substance, negative or positive control at room temperature.
- Number of replicates:
- 3 replicates.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three tissues
- Value:
- 27.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Negative control:
The mean absorbance of the triplicate negative control values was 0.778 which was between the minimum and maximum values of 0.6 and 1.5. The standard
deviation (SD) of the % viability was 5.2 which was below the maximum value of 18.
Positive control:
The percentage mean viability of the positive control was 22.8 ± 1.4 of the negative control. These were below the maximum acceptance values of 40% viability and SD of 18.
EPISKIN Results:
?Sample Tissue viability as percentage of mean OD negative control
Replicate Tissues Mean ± SD Prediction MTT endpoint
a b c
Negative Control 94.0 102.8 103.1 100.0 ± 5.2 Not applicable
Positive Control 21.3 23.0 24.2 22.8 ± 1.4 Irritant
MTF 25.1 24.8 33.7 27.9 ± 5.1 Irritant
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- It was concluded that the test substance, MTF, with a mean tissue viability of 27.9 ± 5.1%, was predicted as irritant to the skin.
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