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EC number: 232-107-5 | CAS number: 7787-20-4
- 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:
- 23 February 2018 - 01 March 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,3-trimethylnorbornan-2-one
- EC Number:
- 232-107-5
- EC Name:
- 1,3,3-trimethylnorbornan-2-one
- Cas Number:
- 7787-20-4
- Molecular formula:
- C10H16O
- IUPAC Name:
- 1,3,3-trimethylnorbornan-2-one
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiSkinTM
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- Justification for test system used:
- The assessment of skin irritation has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals.
One of the validated in vitro test methods adopted by the OECD TG 439 makes use of reconstructed human epidermis (RhE) which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM kit
- Tissue batch number(s): 18-EKIN-009
- Delivery date: 27 February 2018
- Expiration date: 05 March 2018
- Date of initiation of testing: 23 February 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: PBS, volumen no specified
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours at 37°C, 5% CO2
- Spectrophotometer: TECAN Infinite® M200 Microplate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Historical negative control mean OD range = 0.58630-1.13620 (15 min exposure).
- Histology scoring: 21.5 ± 1.2 (CV = 5.7%), specification ≥ 19.5.
- Barrier function: IC50 = 2.1 mg/mL (specification, 1.5 mg/mL ≤ IC50 ≤ 3 mg/mL)
- Morphology: Well-differenciated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum.
- Contamination: no
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: no interference.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the tissue viability after after exposure and post-treatment incubation is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the tissue viability after exposure and post-treatment incubation is greater than 50%. - 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 μL/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 100.19
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (PBS)
- Positive controls validity:
- valid
- Remarks:
- 6.87% viability (5% SDS)
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes. A demonstration of proficiency was performed for the EpiSkinTM kit. Adequate results were obtained for the evaluated chemicals.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, OD mean is 0.69413 (acceptability criteria, 0.6≤OD≤1.5). SD of the negative control group was 0.00378 (acceptablility criteria, SD ≤ 18%).
- Acceptance criteria met for positive control: yes, SD of the positive control group was 0.21% (acceptablility criteria, SD ≤ 18%)
- Acceptance criteria met for variability between replicate measurements: yes. SD of test item was 1.23% (acceptablility criteria, SD ≤ 18%).
Any other information on results incl. tables
Table 1. Mean OD Values of Individual Epidermis Units
|
Absorption (OD570) |
|
||
R1 |
R2 |
R3 |
Mean |
|
Negative control |
0.73520 |
0.73360 |
0.74080 |
0.73653 |
Positive control |
0.09110 |
0.09080 |
0.08845 |
0.09012 |
Test Item |
0.74580 |
0.73885 |
0.72885 |
0.73783 |
Table 2. True OD Values of Individual Epidermis Units
|
Absorption (OD570) |
||||
R1 |
R2 |
R3 |
Mean |
SD |
|
Negative control |
0.69280 |
0.69120 |
0.69840 |
0.69413 |
0.00378 |
Positive control |
0.04870 |
0.04840 |
0.04605 |
0.04772 |
0.00145 |
Test Item |
0.70340 |
0.69645 |
0.68645 |
0.69543 |
0.00852 |
Blank OD Value (mean of 6 replicate values): 0.04240
True OD value = OD Raw – OD Blank
Table 3. Individual Tissue Viability of Epidermis Units (Relative)
|
% Individual Viability |
||||
R1 |
R2 |
R3 |
Mean |
SD |
|
Positive control |
7.02 |
6.97 |
6.63 |
6.87 |
0.21 |
Test Item |
101.33 |
100.33 |
98.89 |
100.19 |
1.23 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Under in vitro RHE test method performed in Episkin model the test item is predicted to be non-irritant.
- Executive summary:
An in vitro skin irritation test of the test item was performed in a reconstructed human EpiSkin TM model, according to OECD TG 439 (GLP study). Three epidermis units were treated with 10 μL test item for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with PBS. The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues with MTT, extracting the precipitated formazan crystals using isopropanol, incubating the tissues at room temperature protected from light for 4 hours, and finally measuring the concentration of formazan by determining the OD at 570 nm. Under the test conditions, the mean percent viability of the treated tissues was 100.19%, versus 6.87% of the positive control (5% Sodium Dodecyl Sulfate) and 100% of the negative control (PBS). Therefore, the test item is predicted to be non-irritant.
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