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EC number: 204-679-6 | CAS number: 124-09-4
- 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:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and Guideline Study. No deviations were observed.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexamethylenediamine
- EC Number:
- 204-679-6
- EC Name:
- Hexamethylenediamine
- Cas Number:
- 124-09-4
- Molecular formula:
- C6H16N2
- IUPAC Name:
- hexane-1,6-diamine
- Details on test material:
- - Name of test material (as cited in study report): 1.6-hexadiamine, H-22685, HMDA, 1.6-diaminohexane, 77H3446
- Substance type:
- Physical state: water-white solid
- Composition of test material, percentage of components: 99.9% Hexamethylene Diamine
- Lot/batch No.: no data
- Stability under test conditions: the test substance appeared to be stable under the conditions of the study, no evidence of instability was observed
Constituent 1
Test animals
- Species:
- other: In Vitro International Corrositex assay kit
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- other: Biobarrier membrane or matrix discs
- Vehicle:
- water
- Controls:
- other: A Positive control vial for each concentration group contained 70% nitric acid and a negative control vial for each concentration group contained 10% citric acid.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500µL
- Concentration (if solution): 35 %, 70 % and 85 %
VEHICLE
- concentration : 65 %, 30 % and 15 % - Duration of treatment / exposure:
- - 0 to 3 min
- > 3 to 60 min
- > 60 to 240 min
- > 240 min - Observation period:
- Up to the test substance break through the membranes.
- Number of animals:
- No animals, in vitro
- Details on study design:
- The purpose of this study was to determine skin corrosion potential of 1,6-hexanediamine using the In Vitro International Corrositex assay kit. The results were used to determine the United Nations' Package Group. The study was based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.
Principles of Methodology:
Biobarrier membrane or matrix discs must be prepared and stored at 2-8ºC for at least 2 hours prior to conducting the assay. The Corrositex Biobarrier Membrane consisted of a reconstituted collagen matrix.
Protocol:
The three concentrations of H-22685 (35%, 70%, and 85%) were prepared by mixing the appropriate amount of test substance with deionized water approximately 30 minutes prior to conducting the assay. The biobarrier membrane discs were prepared 1 day prior to conducting the assay. The test substance was first tested to determine if the sample was compatible with the Corrositex system. Approximately 150 µL of the test substance was added to the Qualify test tube, shaken, and allowed to stand for 1 minute. A change in color or consistency was observed so Step 2 for categorization was initiated. Approximately 150 µL of test substance was added to test tubes labeled A (yellow solution) and B (clear solution). The test tubes were capped and shaken. A color change was noted for all three concentrations; the color was matched to the corresponding color charts on the Corrositex Testing Protocol Poster. The color change for each concentration corresponding to Category I. Step 3 for classification was then started. A membrane disc containing the biobarrier matrix was placed into a chemical detection system (CDS) vial. Approximately 150 µL of a 35% solution of 1,6-hexanediamine was pipetted on top of the discs. The vial was then observed for a change in the CDS. This procedure was followed for each of the 4 test vials. Step 3 was performed with a 70% concentration of 1,6-hexanediamine and with a 85% concentration of 1,6-hexanediamine. One vial for each test concentration was similarly treated with a positive control (70% nitric acid) and a negative control (10% citric acid). The time it took for the test substance to break through the membranes was documented. The mean value of the breakthrough time for all 4 vials was used in determining the package group.
Classification of category I Substances:
Greater than 3 to 60 minutes = Package Group II.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- vial 1 to 4
- Value:
- > 34 - < 44
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Results for 35% solution. Based on Corrositex Times. Remarks: The mean breakthrough time for all 4 vials was 39 minutes and 46 seconds.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- vial 1 to 4
- Value:
- > 39 - < 40
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Results for 70% solution. Based on Corrositex Times. Remarks: The mean breakthrough time for all 4 vials was 39 minutes and 29 seconds.
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- vial 1 to 4
- Value:
- > 45 - <= 46
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Results for 85% solution. Based on Corrositex Times. Remarks: The mean breakthrough time for all 4 vials was 45 minutes and 49 seconds..
Any other information on results incl. tables
Table 7.3.1/2: Breakthrough of the biobarrier occurred as follows (hour:minute:second):
|
35% |
70% |
85% |
Vial 1 |
00 41 49 |
00 39 38 |
00 46 00 |
Vial 2 |
00 34 44 |
00 39 30 |
00 45 51 |
Vial 3 |
00 43 55 |
00 39 26 |
00 45 45 |
Vial 4 |
00 34 35 |
00 39 21 |
00 45 40 |
Mean Value |
00 38 46 |
00 39 29 |
00 45 49 |
Vial 5 (Positive Control) |
00 01 48 |
00 01 48 |
00 02 08 |
Vial 6 (Negative Control) |
02 50 05 |
01 31 28 |
01 37 50 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, the 35%, 70% and 85% HMD aqueous solutions were corrosive and were assigned to Packing Group II. HMD is classified as Corrosif (C, R34) and in category 1B according to the CLP regulation (1272/2008).
- Executive summary:
The purpose of this study was to determine skin corrosion potential of 1.6-hexadiamine (HMD) according to the OECD 435 (in vitro test) . Aqueous dilutions of HMD at 35%, 70% and 85% were evaluated for skin corrosion potential using the in vitro International Corrositex¿ assay. The results of the assay were used to determine the United Nations corrosive packing group. Corrositex is a standardized and quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.
For each concentration, appromately 150 µL was applied to each 4 membrane discs. The time each aliquot of test substance passed through the biobarrier membrane was documented. A mean breakthrough time was calculated for each concentration of HMD tested. The packing group designations were determined based on the Corrositex¿ category assigned and mean breakthrough times. All 3 concentrations of HMD were determined to be Category I.
A 35 % HMD concentration passed through all 4 of the membranes in less than 44 minutes. The mean breakthrough time for all 4 vials was 38 minutes and 46 seconds. A 70% concentration of the test substance passed through all 4 of the membranes in less than 47 minutes. The mean breakthrough time for all 4 vials was 39 minutes and 29 seconds. A 85% concentration of HMD passed through all 4 of the membranes in less than 45 minutes. The mean breakthrough time for all 4 vials was 45 minutes and 49 seconds.
Under the conditions of this test, the 35%, 70% and 85% aqueous solutions of HMD were corrosive and were assigned to Packing Group II. HMD is classified as Corrosif (C, R34) and in category 1B according to the CLP regulation (1272/2008).
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