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EC number: 241-367-9 | CAS number: 17345-61-8
- 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:
- 06 December 2016 - 13 January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- Adopted July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Community (EC). Commission regulation (EC) 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"
- Version / remarks:
- Official Journal of the European Union No. L142, 31 May 2008.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,4-dihydroxybenzonitrile
- EC Number:
- 241-367-9
- EC Name:
- 3,4-dihydroxybenzonitrile
- Cas Number:
- 17345-61-8
- Molecular formula:
- C7H5NO2
- IUPAC Name:
- 3,4-dihydroxybenzonitrile
- Test material form:
- solid: particulate/powder
- Remarks:
- white to brownish
- Details on test material:
- Batch 151222
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm 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)
- Remarks:
- The solid test item was applied directly on top of the skin tissue. CH02906 was spread to match the size of the tissue.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:EpiDerm Skin Model (EPI-200)
- Tissue batch number(s):Lot no.: 24940 kit J and K (first experiment) 24956 kit Q and R (second experiment)
- Production date: /
- Shipping date: 7/12/2016 (first experiment); 11/12/2017 (second experiment)
- Delivery date: /
- Date of initiation of testing: 8/12/2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 ± 1.0°C (actual range 35.1 - 37.0°C)
- Temperature of post-treatment incubation (if applicable): 37.0 ± 1.0°C (actual range 35.1 - 37.0°C)was
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: /
- Observable damage in the tissue due to washing: one of the replicates of the 3-minutes treatment time
- Modifications to validated SOP:
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/ml) was diluted (1:5) with MTT diluent (supplemented DMEM). Both supplied by MatTek Corporation.
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
- Filter:
- Filter bandwidth:
- Linear OD range of spectrophotometer:
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD570 = 1.744 +- 0.093 (first experiment) and 1.407 +- 0.066 (second experiment), acceptance criteria: OD570= 1.0-3.0
- Barrier function: ET-50 = 5.21 hours (first experiment) and 8.09 hours (second experiment), acceptance criteria: 4.77-8.72hours
- Morphology:
- Contamination: Sterile based on long term antibiotic and antimycotic free culture
- Reproducibility:
NUMBER OF REPLICATE TISSUES: 4 (2 used after 3 minutes of exposure, 2 after 1 hour of exposure)
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: not needed
- Fresh tissues / killed tissues
- Procedure used to prepare the killed tissues (if applicable):
- N. of replicates :
- Method of calculation used:
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- 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%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: / - Amount/concentration applied:
- At least 25 mg of CH02906 was added to 1 ml MTT (Sigma, Zwijndrecht, The Netherlands) solution (1 mg/ml) in phosphate buffered saline.
- Duration of treatment / exposure:
- 3 minutes of exposure
1 hour of exposure - Number of replicates:
- 4
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- experiment 1: 3-minute exposure
- Value:
- ca. 72
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: results replicates different
- Remarks:
- one replicate was found to be corrosive (cell viability 45%), the other replicate non-corrosive (100% cell viability). The variation was most probably caused by problems during rinsing: the test item could not be fully removed from one replicate. Therefore, a second experiment was conducted.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- experiment 1: 1-hour exposure
- Value:
- ca. 83
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- experiment 2: 3-minutes exposure
- Value:
- ca. 104
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- experiment 2: 1-hour exposure
- Value:
- ca. 81
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: High variability
- Remarks:
- Although the variability between the two replicates was high (54%, cell viability of replicate 1 and 2 were 51% and 112%, respectively), both replicates were found to be non-corrosive.
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system:/
- Direct-MTT reduction:no direct MTT-reduction
- Colour interference with MTT: no colour interference
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (0.8- Acceptance criteria met for positive control: yes (mean tissue viability <15% after 1 hour of exposure: 14% experiment 1, 7% experiment 2)
- Acceptance criteria met for variability between replicate measurements: yes for the 1-hour exposure in the first experiment (8.8%) and for the 3-minute exposure in the second experiment (19%)
- Range of historical values if different from the ones specified in the test guideline:
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It is concluded that this test was valid and that CH02906 was not corrosive in the in vitro skin corrosion test under the experimental conditions described.
- Executive summary:
In vitroskin corrosion test with CH02906 using a human skin model.
This report describes the ability of CH02906 to induce skin corrosion on a human three- dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of CH02906 was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD431 and EC B.40 BIS guidelines.
Batch 151222 of CH02906 was a white to brownish powder with a purity of 99.9%. Skin tissue was moistened with 25 μl of Milli-Q water and at least 25 mg of CH02906 was applied directly on top of the skin tissue.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with CH02906 compared to the negative control tissues was 72% and 83%, respectively. At the 3-minutes treatment time the Coefficient of Variation between tissue replicates was 55% and the results of the individual skin tissues were 45 and 100%. Therefore one tissue had a corrosive result and the other tissue was not corrosive. This variation between replicates is most probably caused by the rinsing of the skin tissues after exposure. At the 3-minutes treatment time the test item could not be completely removed from one of the duplicate tissues during the rinsing process. The corrosion study was therefore repeated in a second experiment.
The relative mean tissue viability obtained after 3-minute and 1-hour treatments with CH02906 compared to the negative control tissues was 104% and 81%, respectively in the second experiment. Although at the 1-hour treatment time the Coefficient of Variation between tissue replicates was 54% in experiment 2, both individual skin tissues had a non-corrosive result of 51 and 112%. This non-corrosive result after 1-hour was also observed in the first experiment. Because the mean relative tissue viability for CH02906 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment, CH02906 is considered to be not corrosive.
The positive control had a mean relative tissue viability of 14 and 7% after the 1-hour exposure in the first and second experiment, respectively. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within (1.046 - 1.658) the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit2.8) and the laboratory historical control data range in both experiments. In the range of 20 - 100% viability, the Coefficient of Variation between tissue replicates was20% for the control tissues, indicating that the test system functioned properly in both experiments.
Finally, it is concluded that this test was valid and that CH02906 was not corrosive in thein vitroskin corrosion test under the experimental conditions described in this report.
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