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EC number: 210-862-1 | CAS number: 624-78-2
- 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:
- 26 October 2016 - 01 December 2016
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro human skin corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl(methyl)amine
- EC Number:
- 210-862-1
- EC Name:
- Ethyl(methyl)amine
- Cas Number:
- 624-78-2
- Molecular formula:
- C3H9N
- IUPAC Name:
- ethyl(methyl)amine
Constituent 1
- Specific details on test material used for the study:
- Name: ETHYLMETHYLAMINE (EMA)
Synonyms: N-Ethylmethylamine, EMA
Batch No.: E310971456
Description: colorless liquid
Storage conditions: at room temperature and protected from light
Analytical purity: 99.79%
Expiry date: 12 July 2018.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human epidermal keratinocytes
- Cell source:
- foreskin from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Species: human reconstructed epidermis (tissues).
Supplier: Episkin Laboratories, Lyon, France.
Selection: at receipt, the medium quality and temperature indicators were checked to ensure the good quality of the tissues before use.
Storage conditions: the living tissues were kept at room temperature from receipt at CiToxLAB France until required.
Description: the EpiskinTM model consists of an airlifted, living, multilayered epidermal tissue construction (surface 0.38 cm2), reconstructed from normal human epidermal keratinocytes for 13 days and produced in polycarbonate inserts in a serum-free and chemically defined medium. The model features a normal ultra structure and is functionally equivalent to human in vivo epidermis. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): original form
NEGATIVE CONTROL: 0.9% NaCl.
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 0.9% NaCl
POSITIVE CONTROL: glacial acetic acid.
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): original form. - Duration of treatment / exposure:
- Exposure period of 3, 60 and 240 minutes, followed by rinsing.
- Duration of post-treatment incubation (if applicable):
- Not applicable.
- Number of replicates:
- Duplicate tissues for each timepoint and tested substance (test item, negative control, positive control)
Test animals
- Species:
- other: reconstituted human epidermis
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Episkin TM Model Kit (0.38 cm2 tissues) supplied by SkinEthic Laboratories, Nice, France.
Medium and Incubation T°C: 37°C
Dates of experimental phase: from 03 November 2016 to 01 December 2016.
Test system
- Type of coverage:
- other: not applicable (in vitro)
- Preparation of test site:
- other: not applicable (in vitro)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro negative and positive controls
- Number of animals:
- Not applicable
- Details on study design:
- PRELIMINARY TEST:
Test for direct MTT reduction with the test item and Test for the detection of the coloring potential of the test item.
MAIN TEST:
Treatment
The test item, positive and negative controls were applied on duplicate tissue. As the test item was found to have direct MTT reducing properties in the preliminary test, MTT reducing test item and negative control were applied to two water-killed tissues for each exposure time.
A volume of 50 µL was evenly applied to the surface of each tissue, using a positive displacement pipette, taking care to spread the items over the whole tissue surface area without damaging the tissue sample.
Plates were incubated at room temperature as follows: positive control for 4 hours (± 10 minutes); test item and negative control for 3 minutes (± 5 seconds), 1 hour (± 5 minutes) and 4 hours (± 10 minutes).
The positive control incubated for 4 hours (± 10 minutes) acted as control for all incubation times.
Rinsing of tissues
For all treated tissues (test item-treated, positive and negative control) at the end of the designated incubation period, each tissue insert was removed from the well of the treatment plate and rinsed with D PBS.
Rinsing was achieved by gently filling and emptying each tissue insert 12 times with 2 mL D-PBS and the surface of each tissue was swept with a cotton-bud to gently remove any residual items.
MTT viability assayformazan transformation by viable cells, after 3-hour MTT incubation.
Optical density measurement
The OD was measured at a wavelength of 570 nm.
SCORING SYSTEM:
Data analysis for MTT reducing substances
Since the test item may directly reduce MTT, the percentage of OD due to non specific MTT reduction was calculated and subtracted to obtain the viability percentage.
- Non-Specific MTT reduction (NSMTT) calculation:
cOD 0.9%NaCl-treated Killed tissues = ODNK – ODblank
cOD Test Item-treated Killed tissues = ODTIK – ODblank
NSMTT = [(mean cODTIK – mean CodNK) / mean cODNC] x 100
If the NSMTT is 0% < NSMTT = 50% relative to the negative control (living tissues), the corrected OD value of the test item-treated water-killed tissues is subtracted from the mean cOD of the test item treated living tissues to obtain the true amount of MTT reduction (i.e. the MTT reduction produced by metabolic conversion only).
- True MTT metabolic conversion (TODTI):
TODTI = [mean cODTI – (mean cODTIK – mean cODUK)]
If the NSMTT is < 0% relative to the negative control, the corrected OD value of the water-killed tissues were not subtracted from the mean cOD of the test item-treated living tissues.
After calculation of each TODTI (i.e. for each treatment exposure), relative mean viability was calculated as follows:
Relative mean viability = (TODTI / mean cODNC) x 100
Acceptance criteria for negative and positive controls
The main test was considered as valid if the following criteria were fully met:
- the mean cOD of the negative control should be between 0.600 and 1.500,
- the relative mean viability of the positive control should be = 20% of the relative mean viability of the negative control,
- in the range 20-100% viability and for ODs = 0.3, the difference of viability between the two tissue replicates should not exceed 30%.
Interpretation: see below
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 19
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min. Reversibility: no data not applicable. Remarks: 100% = negative control. (migrated information)
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 16
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 min. Reversibility: no data not applicable. Remarks: 100% = negative control. (migrated information)
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 14
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Reversibility: no data not applicable. Remarks: 100% = negative control. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test item tested in its original form, is considered to be corrosive to the skin.
According to these results, the classification of the test item is the following:
Corrosive Category 1A (HS: H314) (UN GHS 2013 and Regulation 1272/2008/EEC) - Executive summary:
The objective of this study was to evaluate the corrosive potential of the test item using the EpiskinTMreconstructed skin model.
This study was conducted in compliance with CiToxLAB France’s standard operating procedures and the principles of Good Laboratory Practices.
Method
Preliminary tests were performed to detect the ability of the test item to interfere with cell viability measurements by directly reducing MTT or by color interference.
Following the preliminary tests, the corrosive potential of the test item was tested in the main assay. Test item, and negative and positive controls were applied on duplicate tissues and incubated at room temperature as follows: positive control for 4 hours (± 10 minutes); test item and negative control for 3 minutes (± 5 seconds), 1 hour (± 5 minutes) and 4 hours (± 10 minutes).
At the end of the designated incubation period, each tissue insert was rinsed with D-PBS and placed into fresh assay medium pre-filled well. Then, they will be incubated with a MTT solution (0.3 mg/mL) for 3 hours (± 15 minutes) at +37°C, 5%CO2in humidified atmosphere. At the end of the MTT incubation period, the tissues were removed from their plastic insert. Any tissue discoloration was evaluated with the naked eye (discolored surface area and intensity).
Then, for each tissue, the epidermis was separated from the collagen matrix and both parts were put into acidified isopropanol overnight to extract the formazan (reduced MTT) out of the MTT-loaded tissues. At the end of the extraction period, the optical density of each extract was measured at 570 nm.
Relative viability values were calculated for each tissue and expressed as percentages of the negative control tissues viability which was set at 100% (reference viability).
Results
Preliminary tests
In the preliminary tests, the test item was found to have direct MTT reducing properties but no coloring properties.
Main test
All acceptance criteria for the negative and positive controls were fulfilled (Table 1), therefore the study was considered to be valid.
The true MTT metabolic conversion relative mean viabilities of the test item were:
. 19% for the 3 minutes exposure,
. 14% for the 1 hour exposure,
. 16% for the 4 hours exposure.
Discussion
The NSMTT values relative to the negative control (living tissues) were equal to 25% for the 3 minutes exposure, 9% for the 1 hour exposure and -1% for the 4 hours exposure.
These NSMTT values were highly heterogeneous between the different treatment exposure periods, and non-coherently distributed, since values decreased over time.
This could be explained by:
. the high volatility of the test item. Despite the use of sealer, the test item could have evaporated and remained in the well in a gaseous state, thus reducing over time the quantity of liquid test item in contact with tissues,
. the corrosive potential of the test item. A pink coloration of the medium (normally pale yellow) was noted at the end of treatment periods. This indicated the passage of the test item through the tissues and their collagen membrane.
Both phenomena could have induced a strong time-related decrease in the amount of test item remaining inside the tissues, explaining the non-consistency of the values of NSMTT over time.
Since at all exposure periods the mean viabilities were < 35%,the results met the criteria for a corrosive response.
Conclusion
The test item, tested in its original form, is considered to be corrosive to the skin.
According to these results, the classification of the test item is the following:
. Corrosive Category 1A (HS: H314)(UN GHS 2013 and Regulation 1272/2008/EEC)
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