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EC number: 255-256-8 | CAS number: 41199-19-3
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 June 2020 - 5 June 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test". Official Journal of the European Union No. L142
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol
- EC Number:
- 255-256-8
- EC Name:
- 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol
- Cas Number:
- 41199-19-3
- Molecular formula:
- C13H22O
- IUPAC Name:
- 2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 ± 1.0ºC
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 run (duplicates were used per exposure period)
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%. In addition, a test item considered non-corrosive (viability ≥ 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
- The test substance is considered to be non-corrosive to skin if the relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%. In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%.
ACCEPTABILITY CRITERIA
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be within the laboratory historical control data range and the acceptance limits of OECD431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8).
b) The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL
- Concentration: undiluted
NEGATIVE CONTROL
- Amount applied: 50 μL
POSITIVE CONTROL
- Amount applied: 50 μL - Duration of treatment / exposure:
- 3-minute exposure or 1-hour exposure
- Duration of post-treatment incubation (if applicable):
- Incubation with 300 μL MTT-medium for 3 hours
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- after 3-minute exposure
- Value:
- 100
- Negative controls validity:
- valid
- Remarks:
- Mean (OD570): 2.008 ± 0.048 (HCD OD570: 1.258 – 2.414)
- Positive controls validity:
- valid
- Remarks:
- 6.8%; Mean (OD570): 0.137 ± 0.002 (HCD OD570: 0.080 – 0.671)
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- after 1-hour exposure
- Value:
- 47
- Negative controls validity:
- valid
- Remarks:
- Mean (OD570): 1.891 ± 0.199 (HCD OD570: 1.317 – 2.371)
- Positive controls validity:
- valid
- Remarks:
- 7.2%; Mean (OD570): 0.137 ± 0.019 (HCD OD570: 0.032 – 0.319)
- Other effects / acceptance of results:
- The test item was checked for color interference in aqueous conditions. Addition of the test item to Milli-Q and isopropanol resulted after subtraction of the blank in an OD of -0.001 and 0.001, respectively. Therefore it was concluded that the test item did not induce color interference. In addition, because no color change was observed in the presence of MTT it was concluded that the test item did not interact with the MTT endpoint.
The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 100% and 47% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive.
ACCEPTIBILITY CRITERIA
a) The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range
b) The mean relative tissue viability following the 1-hour exposure to the positive control was 7.2%.
c) In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 14%, except for the 1-hour test item treated tissues, which showed a Coefficient of Variation of 36%. However, since the results of the individual treated tissues were within the same category, this deviation did not affect the study integrity indicating that the test system functioned properly.
Any other information on results incl. tables
Table 1: Mean Absorption in the in vitro Skin Corrosion Test with Ambrinol
|
3-minute application (OD570) |
1-hour application (OD570) |
||||||
|
A |
B |
Mean |
SD |
A |
B |
Mean |
SD |
Negative control |
1.974 |
2.041 |
2.008 ± |
0.048 |
1.750 |
2.032 |
1.891 |
0.199 |
Test item |
2.094 |
1.910 |
2.002 ± |
0.130 |
1.075 |
0.689 |
0.882 |
0.273 |
Positive control |
0.135 |
0.139 |
0.137 ± |
0.002 |
0.123 |
0.151 |
0.137 |
0.019 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive to the skin
- Remarks:
- in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance is not corrosive to the skin.
- Executive summary:
The corrosive potential of the test item was tested through topical application for 3 minutes and 1 hour. The study procedures described in this report were according to OECD TG 431 and GLP principles. The test item (a liquid) was applied undiluted (50 μL) directly on top of the skin tissue. The positive control had a mean relative tissue viability of 7.2% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD TG 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 14%, except for the 1-hour test item treated tissues, which showed a Coefficient of Variation of 36%. However, since both individual values were in the same category, this minor deviation did not affect the study integrity indicating that the test system functioned properly. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 100% and 47%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive. In conclusion, the test item is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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