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EC number: 942-426-8 | CAS number: -
- 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 February 18 to 24, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 439 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Program (inspected on March 12 to 14, 2014 / Signed on May 12, 2014)
Test material
- Reference substance name:
- (3R)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol
- Cas Number:
- 253454-12-5
- Molecular formula:
- C15H30O
- IUPAC Name:
- (3R)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol
- Reference substance name:
- (3S)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol
- Cas Number:
- 253454-10-3
- Molecular formula:
- C15H30O
- IUPAC Name:
- (3S)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless liquid
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature, protected from light, in the original container (aluminium bottle)
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ Reconstructed Human Epidermis Model Kit, SkinEthic Laboratories, Lyon, France
- Tissue batch number(s): 14-EKIN-005
- Production date: 18 February 2014
- Shipping date: 18 February 2014
- Delivery date: 18 February 2014
- Date of initiation of testing: 18-24 February 2014
- Expiry date: 24 February 2014
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: ambient temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Not reported. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item.
- Observable damage in the tissue due to washing: none
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/L
- Incubation time: 3 hours
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 562 nm
- Filter: without reference filter
- Filter bandwidth: not applicable
- Linear OD range of spectrophotometer: not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
- Barrier function: 2.2 mg/mL ( ≥ 1.5 mg/mL)
- Morphology: well differenciated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum
- Contamination:
Absence of HIV1 and 2 antobodies, hepatitis C antibodies, hepatitis B antigen HBs
Absence of bacteria, fungus and mycoplasma
- Reproducibility: not reported
NUMBER OF REPLICATE TISSUES: triplicate
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : the test item did not directly reduce MTT
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after the 15-min exposure period followed by the 42h post-exposure period is less or equal to 50%
- The test substance is considered to be non-irritant to skin if the viability after the 15-min exposure period followed by the 42h post-exposure period 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
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): undiluted
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): 5% w/v - Duration of treatment / exposure:
- 15 minutes at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- Triplicate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 63.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: the test item was not able to directly reduce MTT
- Colour interference with MTT: no colour interference were observed
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD562 for the negative control treated tissues was 1.013 and the standard deviation value of the percentage viability was 2.4%. The negative control acceptance criterion was therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 5.3% relative to the negative control treated tissues and the standard deviation value of the percentage viability was 1.1%. The positive control acceptance criterion was therefore satisfied.
- Acceptance criteria met for variability between replicate measurements:
- Range of historical values if different from the ones specified in the test guideline: The standard deviation calculated from individual percentage tissue viabilities of the three identically treated test item tissues was 8.4%. The test item acceptance criterion was therefore satisfied.
For the previous 35 experiments conducted between May 2013 and February 2014 using this test method, the mean OD of the positive control was 0.084 ± 0.036 and the mean percentage viability was 9.6 ± 4.4. In this same period the mean OD of the negative control was 0.898 ±0.106.
The positive control reflected the ability to respond to an irritant test item under the conditions of the test. The negative control in this study was greater than the mean OD of the negative control in the previous 35 experiments conducted with this test method.
Any other information on results incl. tables
Table 7.3.1/1: Mean OD562 Values and Percentage 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 |
1.034 |
1.013 |
0.024 |
102.1 |
100* |
2.4 |
1.018 |
100.5 |
|||||
0.986 |
97.3 |
|||||
Positive Control Item |
0.062 |
0.054 |
0.011 |
6.1 |
5.3 |
1.1 |
0.042 |
4.1 |
|||||
0.058 |
5.7 |
|||||
Test Item |
0.687 |
0.646 |
0.085 |
67.8 |
63.7 |
8.4 |
0.702 |
69.3 |
|||||
0.548 |
54.1 |
|||||
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item was classified as non-irritant according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
An in vitro skin irritation study was performed according to the OECD Guideline 439 and in compliance with GLP, using the EPISKINTM reconstructed human epidermis model. Triplicate tissues were treated with the test item 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 viability of the test item treated tissues was 63.7% after the 15‑minute exposure period and 42 hours post‑exposure incubation period.
The relative mean tissue viability for the positive control treated tissues was 5.3% relative to the negative control treated tissues and the standard deviation value of the percentage viability was 1.1%. The positive control acceptance criterion was therefore satisfied. The mean OD562 for the negative control treated tissues was 1.013 and the standard deviation value of the percentage viability was 2.4%. The negative control acceptance criterion was therefore satisfied. The standard deviation calculated from individual percentage tissue viabilities of the three identically treated test item tissues was 8.4%. The test item acceptance criterion was therefore satisfied.
Under the test conditions, test item was classified as non-irritant according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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