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EC number: 263-139-8 | CAS number: 61790-47-4
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-25 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- GLP compliance:
- yes
- Remarks:
- Except for the following: - Information about purity/composition of the test item was not available prior to completion of the study. - The quality environment in which the characterisation of the test item was performed was not known.
Test material
- Reference substance name:
- Amines, rosin
- EC Number:
- 263-139-8
- EC Name:
- Amines, rosin
- Cas Number:
- 61790-47-4
- Molecular formula:
- C19H31N1
- IUPAC Name:
- 1-[(1R,4aR,10aS)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthren-1-yl]methanamine; 1-[1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthren-1-yl]methanamine
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rosin, Batch: 542700
- Appearance: Transparent pale amber viscous liquid
- Expiration date of the lot/batch: 31 March 2016
- Purity test date: Not indicated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: EPI-200, normal, human-derived epidermal keratinocytes
- Cell source:
- other: MatTek Corporation, Ashland MA, U.S.A.
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION:
EpiDerm Skin Model (EPI-200, Lot no.: 22676 kit K and kit J). 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.
Environmental conditions:
- Prior to the assay, skin tissues were kept refrigerated from the day they were received.
- All incubations, with the exception of the test item incubation of 3 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 58 - 90%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C
(actual range 36.3 - 37.3°C).
- Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day. - Temporary deviations from the temperature, humidity and CO2 percentage may occur due to opening and closing of the incubator door.
- Based on laboratory historical data these deviations are considered not to affect the study integrity.
APPLICATION OF TEST SUBSTANCE
- 1 hour before the start of the assay, tissues were transferred to 6-well plates containing 0.9 mL DMEM medium per well. The plates were incubated for approximately 1.5 hours at 37 ± 1°C
- The medium was replaced with fresh DMEM medium just before Rosin Amine 90 was applied. The test was performed on a total of 4 tissues per test item together with a negative control and positive control.
- Two tissues were used for a 3-minute exposure to Rosin Amine 90 and two for a 1-hour exposure. Fifty µl of the undiluted test item was added into the 6-well plates on top of the skin tissues.
- The remaining tissues were treated with 50 µl Milli-Q water (negative control) and with 50 µl 8N KOH (positive control), respectively.
- Following the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test item. Rinsed tissues were kept in 24 well plates on 300 µl DMEM medium until 6 tissues (= one application time) were dosed and rinsed.
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT concentrate (5 mg/ml) diluted (1:5) with MTT diluent (supplemented DMEM). Both supplied by MatTek Corporatio.
CELL VIABILITY MEASURMENT / NUMBER OF INDEPENDENT TESTING RUNS
The DMEM medium was replaced by 300 µl MTT-medium and tissues were incubated for 3 hours at 37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and formazan was extracted with 2 ml isopropanol (MatTek corporation) over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 570 nm in triplicate with the TECAN Infinite® M200 Pro Plate Reader.
Test for the interference of the test item with the MTT endpoint:
A test item may interfere with the MTT endpoint if it is coloured and/or it is able to directly reduce MTT. The cell viability measurement is affected only if the test item is present on the tissues when the MTT viability test is performed.
PREDICTION MODEL / DECISION CRITERIA:
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430:
Cell viability was calculated for each tissue as percentage of the mean of the negative control tissues. Skin corrosion potential of the test item was classified according to remaining cell viability following exposure of the test item with either of the two exposure times. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- 50 µl of the undiluted test item was added into the 6-well plates on top of the skin tissues
NEGATIVE CONTROL
- 50 µl Milli-Q water
POSITIVE CONTROL
- th 50 µl 8N KOH
After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test item. Rinsed tissues were kept in 24 well plates on
300 µl DMEM medium until 6 tissues (= one application time) were dosed and rinsed. - Duration of treatment / exposure:
- 3-minute and 1-hour exposure
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 72
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 15%
- Remarks on result:
- other: not corrosive
- Remarks:
- 3-minute application viability (percentage of control)
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 48
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 11%
- Remarks on result:
- other:
- Remarks:
- 1-hr application viability (percentage of control)
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
Rosin Amine 90 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 and a blue / purple precipitate was not observed it was concluded that Rosin Amine 90 did not interfere with the MTT endpoint.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-minute exposure to the positive control was 15%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 23% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 13%. It was therefore concluded that the test system functioned properly.
ACCEPTANCE OF RESULTS:
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%.
Applicant's summary and conclusion
- Interpretation of results:
- other: Rosin Amine 90 is considered to be not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- It is concluded that this test is valid and that Rosin Amine 90 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.
- Executive summary:
The objective of this study was to evaluate the ability of the test substance, Rosin Amine 90, to induce skin corrosion when applied topically on a human three dimensional epidermal model. The study was conducted in accordance with OECG Guideline 431 and EC Commission Regulation 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'.
The possible corrosive potential of Rosin Amine 90 was tested through topical application for 3 minutes and 1 hour. The test substance was applied undiluted (50 µL) on top of the skin tissue and then following the exposure period, the tissues were washed with phosphate buffered saline. Rinsed tissues were kept in 24 -well plates on 300 µl DMEM medium until 6 tissues were dosed and rinsed (6 tissues = 1 application time).
Rosin Amine 90 was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Since the solutions did not turn blue / purple and a blue / purple precipitate was not observed it was concluded that Rosin Amine 90 did not interfere with the MTT endpoint.
The positive control had a mean relative tissue viability of 15% 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. 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 Rosin Amine 90 compared to the negative control tissues was 72% and 48% respectively. Because the mean relative tissue viability for Rosin Amine 90 was not below 50% after the 3 -minute treatment and not below 15% after the 1 -hour treatment Rosin Amine 90 is considered to be not corrosive.
Finally, it is concluded that this test is valid since the acceptability criteria were met and that Rosin Amine 90 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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