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Diss Factsheets
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EC number: 939-489-9 | CAS number: -
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-06-17 - 2011-08-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- adopted July 19, 2006
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylcyclohexane-1,3-diamine
- EC Number:
- 237-666-9
- EC Name:
- 4-methylcyclohexane-1,3-diamine
- Cas Number:
- 13897-55-7
- Molecular formula:
- C7H16N2
- IUPAC Name:
- 4-methylcyclohexane-1,3-diamine
- Reference substance name:
- 2-methylcyclohexane-1,3-diamine
- EC Number:
- 237-667-4
- EC Name:
- 2-methylcyclohexane-1,3-diamine
- Cas Number:
- 13897-56-8
- Molecular formula:
- C7H16N2
- IUPAC Name:
- 2-methylcyclohexane-1,3-diamine
- Details on test material:
- - Name of test material (as cited in study report): Methyl-Diamino-Cyclohexan; Lab test item number: 10/0117-1
- Physical state: liquid, colourless to yellowish, clear
- Analytical purity: 98.5 mol% (NMR-spectroscopy)
- Lot/batch No.: 84407247G0
- Stability under test conditions: the stability under storage conditions over the study period was guaranteed.
- Storage condition of test material: room temperature (N2 conditions)
- Other: the test substance was homogeneous by visual inspection
- pH-value: ca. 8 (undiluted test substance)
Constituent 1
Constituent 2
Test animals
- Species:
- other: in vitro test on a reconstituted collagen matrix (Corrositex® Biobarrier Membrane).
- Strain:
- other: not applicable (in vitro test)
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 500 μL of the test substance was added onto the membrane disc - Duration of treatment / exposure:
- Not applicable
- Observation period:
- until breakthrough of the test substance through the membrane disc coated with the biobarrier matrix.
- Number of animals:
- not applicable
- Details on study design:
- I TEST SYSTEM
- The Corrositex® assay kit is commercially available from InVitro International.
- 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
II Pretext
- Qualification screen (to determine if a color change can be detected): 150 μL of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required.
- Categorization screen (to categorize weak acids/bases and strong acids/bases): the categorization screen was performed by adding 150 μL of test substance to each tube A and B. Each tube was mixed and the resulting color observed. If required, 2 drops of the "confirm" reagent were added to tube B, the tube mixed, and the resulting color observed. The test substance was scored as category 1 (high acid/alkaline reserve) or category 2 (low acid/alkaline reserve).
III MAIN TEST (Corrositex®)
- Biobarrier preparation: the vial containing the biobarrier matrix powder was placed in a water bath at 64 – 68ºC. The entire content of the biobarrier diluent vial was added slowly to the matrix powder (stir bar rotation) to avoid foaming of the solution. 200 μL of the solubilized matrix was pipetted into each of the membrane discs, and the membrane discs were then refrigerated for at least 2 hours at 2 – 8ºC. The biobarriers were wrapped and stored at 2 – 8ºC for a maximum of 7 days.
- Corrositex® assay (after acceptance of the positive control)
Four vials containing the CDS were used for the test substance. In addition, one vial was used for the PC, NC and for the color (blank) control, each.
a) A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and approximately 500 μL of the test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS.
b) If no color change was observed within three minutes, the remaining membranes were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter the vials were observed for approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier penetration) was recorded.
c) The positive control vial was prepared as described above and received one pellet of sodium hydroxide on top of the membrane disc. This vial was monitored continuously until breakthrough had occurred.
The negative control vial was prepared as described above and received 500 μL of 10% citric acid. This vial was observed for 60 minutes and was evaluated as “non-corrosive” if no reaction had been observed.
IV SCORING SYSTEM
- Corrosive potential was determined on the basis of the average time recorded for the test substance to produce a change in the CDS (see Table 1).
- Acceptance criteria: The Corrositex® assay was accepted if the breakthrough time for the positive control substance was in the historic control range (mean ± 2-3 x standard deviations). To demonstrate the functional integrity of the membrane barrier, the acceptance criterion for the negative control was not to induce membrane breakthrough within a 60 min observation period.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- 6.3
Any other information on results incl. tables
Table 2: Summary of the findings
|
Breakthrough time (min:s) |
||||
|
Vial 1 |
Vial 2 |
Vial 3 |
Vial 4 |
Mean |
Test substance |
5:01 |
4:35 |
7:30 |
8:10 |
6:19 |
Positive control |
10:14 |
- |
- |
- |
- |
Negative control |
NB |
- |
- |
- |
- |
NB = no break through within maximum observation period (60 min)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.