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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
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- Endpoint summary
- Stability
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- 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
Endpoint summary
Administrative data
Description of key information
Skin corrosion
MIT.HCl was found to be corrosive to the skin using the three-dimensional human skin model EPIDERM comprising a reconstructed epidermis with a functional stratum corneum.
In a GLP, OECD 431 study, 25 mg of test article or 50 uL of negative or positive control were applied to EpiDerm tissue 3 and 60 minutes followed by a 42 hour post-incubation period and immediate determination of cytotoxic effects via the MTT reduction assay.
Corrosivity potential of the test article was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with distilled water. The positive control, 8N potassium hydroxide viability was <20% following a 60 minute exposure, thereby confirming thatcorrosivitycould be detected in this test system.
The test article showed evidence ofcorrosivityduring both the short term (3 minute) and prolonged exposures (60 minutes). The mean relative tissue viability was <50% (22%) after the 3 minute exposure and <15% (5.6%) after the 60 minute treatment (+ 42 hour post-incubation).
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.
Skin irritation
A waiver for the skin irritation endpoint has been submitted as the available information indicates that the criteria are met for classification as corrosive to the skin.
Eye irritation
A waiver for the skin irritation endpoint has been submitted as the available information indicates that the criteria are met for classification as corrosive to the skin. Therefore, as MIT.HCl is confirmed to cause skincorrosivity, no further testing is required for ocular irritation/corrosive, with MIT.HCl considered corrosive to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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
- Details on test animals or test system and environmental conditions:
- n/a, in vitro test system used
- 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
- 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"
- 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.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Referenceopen allclose all
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Study period:
- n/a
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No studies are available; however in accordance with the guidance on the application of the CLP criteria, in addition to classification for skin corrosivity, where there is a likelihood of the test article being inhaled the following labelling EUH071 – Corrosive to the respiratory tract should be applied.
Justification for classification or non-classification
Comparison with the CLP criteria
- Skin:
Oct-7-en-1-ol was deemed to be corrosive to the skin in the EpiDerm in vitro corrosivity model conducted under OECD 431. The mean relative tissue viability was <50% (22%) after the 3 minute exposure and <15% (5.6%) after the 60 minute treatment (+ 42 hour post-incubation). In accordance with STEP 2 of the judgement criteria, as tissue viability was <25% following the 3 minute exposure, MIT.HCl is deemed to be corrosive to skin, Category 1A.
Based on the results of this study, MIT.HCl was deemed to be corrosive to the skin, according to the criteria listed in OECD 431. Therefore, according to Annex I Regulation (EC) 1272/2008 the active ingredient, MIT.HCl is classified as Skin corrosion, Category 1A.
- Eye:
A waiver for the skin irritation endpoint has been submitted as the available information indicates that the criteria are met for classification as corrosive to the skin. Therefore, as MIT.HCl is confirmed to cause skincorrosivity, no further testing is required for ocular irritation/corrosive, with MIT.HCl considered corrosive to eyes.
-Respiratory tract:
No studies are available; however in accordance with the guidance on the application of the CLP criteria, in addition to classification for skin corrosivity, where there is a likelihood of the test article being inhaled the following labelling EUH071 – Corrosive to the respiratory tract should be applied.
Overall conclusion:
Based on the results of this study, 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. Consequently, as MIT.HCl is confirmed to cause skin corrosivity, no additional testing is required for ocular irritation/corrosion, with MIT.HCl considered corrosive to the eye - Serious Eye Damage Category 1. In addition, the following labelling EUH071 – Corrosive to the respiratory tract should be applied.
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