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EC number: 247-499-3 | CAS number: 26172-54-3
- 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:
- 20 September 2017 to 21 September 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- (2016)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Methyl-4-Isothiazolin-3-One Hydrochloride
- Cas Number:
- 26172-54-3
- Molecular formula:
- C4H5NOS.HCl
- IUPAC Name:
- 2-Methyl-4-Isothiazolin-3-One Hydrochloride
- Test material form:
- solid
- Details on test material:
- MIT.HCl is manufactred as >99.9% purity therefore technical grade and anlaytical grade material are identical
Constituent 1
- Specific details on test material used for the study:
- - Identification: MIT.HCl (Methyl isothiazolinone hydrochloric acid)
- CAS no.: 26172-54-3
- Source and lot/batch No.of test material: Sigma-Aldrich / 10013913
- Expiration date of the lot/batch: 30 Nov 2018
- Purity test date: 23 Nov 2016
- Purity: >99.9%
- Apperance: White to light beige powder
- Moelcular weight: 151.61 g/mol
- Storage condition of test material: 2 to 8°C, protected from light
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- other: Normal human epidermal keratinocytes (NHEK), derived from neonatal-foreskin tissue
- Details on animal used as source of test system:
- TEST KIT
- Source: MatTex Corporation
- Type: Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum
Cell culture media:
- Assay medium (MatTex Corporation)
- Vehicle / postive controls: purifed water / 8N KOH
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37°C, humidified incubator
- CO2 (%): 5%
IN-LIFE DATES: 20 September 2017 to 21 September 2017 - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Pre-experimental checks:
To check the non-specific MTT-reducing capability of the test article 25 mg of the test article was mixed with 1 mL MTT (1 mg MTT/mL) medium and incubated for 1 hour and observed visually after stirring.
Assessment for Colour Interference
25 mg of test article was added to 0.3 mL of both deionized water and isopropanol and incubated for 60 minutes at 37°C, 5% CO2, 95% RH. Neither solution became coloured, therefore it was deemed not to have the potential to stain the tissue. - Control samples:
- yes, concurrent vehicle
- Amount/concentration applied:
- 50 uL of test article
- Duration of treatment / exposure:
- single exposure / 3 and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 2 replicates/dose/time point
Test animals
- Details on test animals or test system and environmental conditions:
- n/a, in vitro test system used
Test system
- Amount / concentration applied:
- n/a, in vitro test system used
- Duration of treatment / exposure:
- n/a, in vitro test system used
- Observation period:
- n/a, in vitro test system used
- Number of animals:
- n/a, in vitro test system used
- Details on study design:
- n/a, in vitro test system used
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- ca. 22
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: positive indication of corrosivity
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure
- Value:
- ca. 5.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: positive indication of corrosivity
- Other effects / acceptance of results:
- refer to "Any other information on results incl. tables"
Any other information on results incl. tables
Table 7.3.1/01-1: Summary of in vitro EPIDERM corrosivity result following application of MIT.HCL
Test Substance |
Mean OD 579 |
Mean relative tissue viability (%) ±CV |
3 minute exposure |
||
Negative |
1.247 |
100 ±1.7 |
Test article |
0.269 |
22 ±4.9 |
Positive |
0.319 |
-6 ±0.8 |
Positive FK |
0.391 |
|
60 minute exposure |
||
Negative |
1.260 |
100 ±2.4 |
Test article |
0.071 |
5.6 ±6.5 |
Positive |
0.168 |
-0.1 ±2.6 |
Positive FK |
0.170 |
|
FK Freeze killed (Positive control tissue mean)
Skin viability after a three minute or one hour exposure to the test article was 22% and 5.6%, respectively.
The OD values for the negative controls met the acceptance criteria.
Skin viability after a three minute or one hour exposure to the positive control article was -6% and -0.1%, respectively, demonstrating appropriate performance of the assay.
All CVs between replicates were less than 30% and met the acceptance criteria.
The negative and positive control values fell within the laboratory historical control values.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- Under the conditions of this study the MIT.HCl showed irritant effects. The mean relative tissue viability was <50% after 3 minute (22%) and 1 hour (5.6%) exposure. Therefore test article, MIT.HCl, was considered to be corrosive (Sub-category 1A) according to the UN GHS classification system
- Executive summary:
This study was conducted to determine whether the test article,MIT.HCl, causes corrosion in thein vitroskin model EpiDermTM.
Duplicate EpiDermTM inserts were treated with test article, purified water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
Skin viability after a three minute or one hour exposure to the test article was 22% and 5.6%, respectively.
The OD values for the negative controls met the acceptance criteria.
Skin viability after a three minute or one hour exposure to the positive control article was -6% and -0.1%, respectively, demonstrating appropriate performance of the assay.
All CVs between replicates were less than 30% and met the acceptance criteria.
The negative and positive control values fell within the laboratory historical control values.
Under the conditions of this study the MIT.HCl showed irritant effects. The mean relative tissue viability was <50% after 3 minute (22%) and 1 hour (5.6%) exposure. Therefore test article, MIT.HCl, was considered to be corrosive (Sub-category 1A) according to the UN GHS classification system.
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