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EC number: 255-272-5 | CAS number: 41233-93-6
- 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:
- 09.09.2015 to 26.11.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD guidline TG 435, well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium 2-methylbutan-2-olate
- EC Number:
- 255-272-5
- EC Name:
- Potassium 2-methylbutan-2-olate
- Cas Number:
- 41233-93-6
- Molecular formula:
- C5H12O.K
- IUPAC Name:
- potassium 2-methylbutan-2-olate
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- other: Corrositex® kit
- Strain:
- other: reconstituted collagen matrix
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control vials with positive and negative control
- Amount / concentration applied:
- The test substance was applied undiluted. Approximately an amount of 500 mg of the test substance was added onto the membrane disc, which was placed into one vial containing the CDS.
- Duration of treatment / exposure:
- The time after the application of the test substance is recorded until the first change in the indicator solution occurs (i.e. barrier penetration) .
- Observation period:
- The vial is observed for three minutes for any change in the CDS
- Number of animals:
- other: 4 vails
- Details on study design:
- The Corrositex® assay is a standardized in vitro corrosion test. The Corrositex® assay kit is
commercially available from InVitro International.
The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen
matrix. The assay is based on the time that is required for the test substance to penetrate
through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection
System (CDS).
The Corrositex® assay is used to determine the corrosive potential of test substances. The
assay is limited to testing those materials which cause detectable pH changes in the CDS.
The experimental design of this study consisted of a qualification screen with the CDS (to
determine if a color change can be detected) and a categorization screen (to categorize weak
acids/bases and strong acids/bases), which were performed as a pretest (experimental
conduct in accordance with GLP but without a GLP status), and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time
that a color change was observed was recorded manually and the breakthrough times of the
four replicates was used to determine the corrosive potential of the test substance.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: overall irritation score
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 24 s. Remarks: mean breakthrough time. (migrated information)
In vivo
- Irritant / corrosive response data:
- The mean breakthrough time of the test substance determined in the in vitro membrane barrier test was ca. 24 seconds.
Any other information on results incl. tables
Evaluation scheme:
Time required for CDS change1 | ||||
Category 1 | ≤ 3 min | > 3 min ≤ 1 h | >1 h ≤ 4 h | > 4 h |
Category 2 | ≤ 3 min | >3 ≤ 30 min | > 30 ≤ 60 min | > 60 min |
Corrosive potential | corrosive2 | corrosive3 | corrosive4 | non corrosive5 |
1Occasionally, break through times may overlap the borderline between corrosive potential assignment
columns. If the break through times from 2 or more vials indicate a more severe corrosive potential, this
subcategory was assigned to the test material.
2This break through time indicates that the test substance has an extreme corrosive potential and should be
assigned to UN GHS skin corrosivity subcategories 1A or UN Transport Packing Group I as specified in OECD
TG 435 (adopted 19 July 2006) and the test system manufacturer.
3This break through time indicates that the test substance has an intermediate corrosive potential and should
be assigned to UN GHS skin corrosivity subcategories 1B or UN Transport Packing Group II as specified in
OECD TG 435 (adopted 19 July 2006) and the test system manufacturer.
4This break through time indicates that the test substance has a weak corrosive potential and should be
assigned to UN GHS skin corrosivity subcategories 1C or UN Transport Packing Group III as specified in OECD
TG 435 (adopted 19 July 2006) and the test system manufacturer.
5This break through time indicates that the test substance does not have a corrosive potential. The result does
not exclude an irritation potential of the test substance as specified in OECD TG 435 (adopted 19 July 2006)
and the test system manufacturer.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observed results and applying the evaluation criteria cited it was concluded, that the test substance shows a corrosive potential in the
Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean breakthrough time determined in the in vitro membrane barrier test was ca. 24 seconds. The breakthrough time indicates that the test substance has an extreme corrosive potential and should be
assigned to UN GHS skin corrosivity subcategories 1A as specified in the cited OECD TG 435.
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