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EC number: 610-565-0 | CAS number: 50717-99-2
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2015 - March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test".
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (17alpha)-3-ethoxy-19-norpregna-3,5-dien-20-yn-17-ol
- EC Number:
- 619-217-2
- Cas Number:
- 96487-85-3
- Molecular formula:
- C22H30O2
- IUPAC Name:
- (17alpha)-3-ethoxy-19-norpregna-3,5-dien-20-yn-17-ol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: off-white powder
Test item storage: at room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Details on animal used as source of test system:
- Test system
EpiDerm Skin Model (EPI-200, Lot no.: 23271 kit EE and FF).
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Source
MatTek Corporation, Ashland MA, U.S.A. - Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model (EPI-200, kit EE and FF).
- Tissue batch number(s): Lot no.: 23271
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 minutes at room temperature, 1 hour at 37.0 ± 1.0°C
- Temperature of post-treatment incubation (if applicable): 37.0 ± 1.0°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- After the exposure period, the tissues were washed with phosphate buffered saline.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ml
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
INTERPRETATION
Acceptability of the assay
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.
b) The mean relative tissue viability following 3-minute exposure to the positive control should be ≤ 30%.
c) In the range of 20 – 100% viability, the maximum inter-tissue variability (in viability) is ≤ 30% between two tissues treated identically.
d) In the range of 20 – 100% viability, the maximum difference in percentage between the mean viability of two tissues and one of the two tissues is ≤ 15%.
Data evaluation and statistical procedures
A test item is considered corrosive in the skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) 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%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- other: concurrent MTT reduction control
- Amount/concentration applied:
- 36.8 to 46.9 mg of the solid test item
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- none
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute treatment
- Value:
- 83
- Negative controls validity:
- valid
- Remarks:
- within OECD acceptable range
- Positive controls validity:
- valid
- Remarks:
- tissue viability 23%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour treatment
- Value:
- 89
- Negative controls validity:
- valid
- Remarks:
- within the laboratory historical control data range
- Positive controls validity:
- valid
- Remarks:
- tissue viability 8%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Norethyl was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that Norethyl did not interfere with the MTT endpoint.
The mean OD570 of the negative control tissues at the 3-minute treatment was 2.413, which is just outside the historical data range.
Evaluation: The OECD guideline indicates that values up to 2.8 are accepted, therefore this does not affect the study integrity.
The maximum inter-tissue variability in viability between two tissues treated identically was less than 16% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 9% for the negative control and test item and the positive control at the 3-minute treatment. For the positive control at the 1-hour treatment, the maximum inter-tissue variability in viability between two tissues treated identically was equal to 45% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 30%, however since the viabilities were below 20% the acceptability criteria were met. It was therefore concluded that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles.
It is concluded that this test is valid and that the Norethyl is not corrosive in the in vitro skin irritation test. - Executive summary:
In an in vitro skin corrosion test using a human skin model ( EpiDerm Skin Model), the influence of the test substance on the viability of human skin was tested. Skin tissue was moistened with 25 μl of Milli-Q water and the test substance was applied directly to 0.6 cm2 cultured skin (46.8 to 47.9 mg). After 3 minutes or 1 hour, the substance was removed and the viability of the tissues was tested by reduction of MTT. The positive control had a mean relative tissue viability of 21% after 3 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range at the 1-hour treatment and within the acceptable range at the 3-minute treatment. The acceptability criteria for the maximum inter-tissue variability in viability between two tissues treated identically and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues were met, indicating that the test system functioned properly. 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 Norethyl compared to the negative control tissues was 83% and 89%, respectively. Because the mean relative tissue viability for Norethyl was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Norethyl is considered to be not corrosive. Based on these results Norethyl is non-corrosive in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
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