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EC number: 205-530-8 | CAS number: 142-26-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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:
- From May 16, 2017 to June 16, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Optical Density (OD) values were obtained with blanks higher than 0.1 (0.191), causing a deviation from the acceptance criteria. However, this is not considered to be an issue in the interpretation of this study data.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol
- Molecular formula:
- C4H9NO2 (amide) & C6H11NO3 (amido ester)
- IUPAC Name:
- Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- other:
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstructed human epidermal model EpiDermTM
- Justification for test system used:
- Initially the predictive capacity of the modified EpiDerm™ Skin Irritation Test (SIT) test method, using MatTek EpiDermTM tissue model EPI-200, underwent full prospective validation from 2003-2007. The test method components of this method were used to define the essential test methods components of the original and updated ECVAM Performance Standards (PS).
A modification of the original EpiDerm™ SIT was validated using the original ECVAM PS in 2008. In 2008, ESAC concluded that the Modified EpiDerm™ SIT has sufficient accuracy and reliability for prediction of R38 skin irritating and no-label (non-skin irritating) test substances. - Vehicle:
- other:
- Details on test system:
- The reconstructed human epidermal model EpiDermTM (EPI-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised 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.
Lot No.: 25819
Keratinocyte Strain: 00267
MatTek’s EpiDermTM model has been extensively characterised for multiple parameters including morphology, tissue viability, skin barrier function and sterility. QC results for the specific lot of models received (Lot# 25819) were checked in-house for MatTek acceptance ranges with the following outcome:
- Morphology - PASS
- Tissue viability - PASS
- Skin barrier function (ET50 value for 1% Triton X-100) where ET50 is the time taken for 1% Triton X-100 to reduce the viability of the skin model to 50% relative to the negative control)- PASS
- Sterility testing showed no contamination during long term antibiotic and antimycotic free culture- PASS - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Single topical application of 30 μL of neat test substance.
- Duration of treatment / exposure:
- 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, 95% RH).
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Three tissues per condition (n=3).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- ca. 102.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- All validity criteria for the test were met:
- Criteria: the mean OD570 of the negative control (treated with DPBS) tissues is ≥ 0.8 and ≤ 2.8
Result for the test: 1.777
- The mean of the positive control relative percentage viability must be ≤ 20 % of the mean of the negative controls.
Result for the test: 3.8 %
- The standard deviation of OD values for triplicate skin models in each experimental condition must be < 18 %
Results for the test:
NC: 5 %
PC: 0.72 %
Test substance: 11.97%
Optical Density (OD) values obtained with blanks were higher than 0.1 (0.191) causing a deviation from acceptance criteria 4. However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the XCellR8 laboratory and meet our current internal acceptance criteria of blank OD values <0.194 (mean of XCellR8 historical data, based on blanks obtained during the last 66 studies), therefore this is not considered to be an issue in the interpretation of this study data.
This SOP and guideline deviation was not considered to have affected the integrity or interpretation of the results as no equivocal results were obtained.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was considered to be non-irritating to skin.
- Executive summary:
An in vitro study was conducted to determine the skin irritation and corrosion potential of the test substance using the Reconstituted Human Epidermis Test Method according to OECD Guideline 439, in compliance with GLP.
The substance was incubated (in triplicate) with reconstructed human epidermal model EpiDerm™ for 1 hour (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, 95% RH) as a single topical application (30 µL) with the neat test substance. The test material was removed and incubated for a further 42 hours. At the end of the incubation period, the viability of the cells was determined by measuring the enzymatic conversion of the vital dye MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide; Thiazolyl blue tetrazolium bromide). The opticl density was determined using a Spectrophotometer (wavelength 570 nm). Although Optical Density (OD) values obtained with blanks were higher than 0.1 (0.191) causing a deviation from acceptance criteria 4. However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the XCellR8 laboratory and meet our current internal acceptance criteria of blank OD values <0.194 (mean of XCellR8 historical data, based on blanks obtained during the last 66 studies), therefore this is not considered to be an issue in the interpretation of this study data.
This SOP and guideline deviation was not considered to have affected the integrity or interpretation of the results as no equivocal results were obtained.
The mean tissue viability of the treated tissues was determined to be 102.6 %, indicated no irritation under the conditions of the test.
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