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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study meets generally accepted scientific principles (restriction: purity unknown, limited documentation). The registered substance is a reaction product of 2,4-dinitrotoluene and 2,6-dinitrotoluene and hydrogen (common name: diaminomethylcyclohexane or MDACH, respectively) consisting of the two isomers 4 -methylcyclohexane-1,3-diamine (CAS 13897-55-7; molecular weight approx. 128 g/mol) and 2-methylcyclohexane-1,3-diamine (CAS 13897-56-8; molecular weight approx. 128 g/mol). The registered substance was tested in several toxicity studies, which were conducted on the one hand using 4-methylcyclohexane-1,3-diamine (CAS 13897-55-7) which is the main isomer of the registered substance (up to 90%) and on the other hand the reaction product of 2,4-dinitrotoluene and 2,6-dinitrotoluene and hydrogen was tested as such (for details see read across justification, IUCLID chapter 13).
Data source
Reference
- Reference Type:
- publication
- Title:
- Range-Finding Toxicity Data: List VII
- Author:
- Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA, Nycum JS
- Year:
- 1 969
- Bibliographic source:
- Am. Ind. Hyg. Assoc. J. 30: 470-476
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To aevaluate the eye irritation potency of the test substance, a flooding volume (0.5 ml) was instilled directly into the eye of 5 rabbits (not rinsed). Eye injury in rabbits was then recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.
American J. Ophthalmology 29: 1363. - GLP compliance:
- no
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
- Details on test material:
- - Name of test material (as cited in study report): 2,4-diamino-1-methylcyclohexane
No additional details provided
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
not reported
ENVIRONMENTAL CONDITIONS
not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Where dilution of a chemical is necessary, the preferred solvent was propylene glycol from a batch shown to cause no injury, followed by water, and in some cases a deodorized kerosene known as "Deobase" has been used.
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.005, 0.02, 0.1 or 0.5 mL. Guided by the result and the table of injury grades below, additional applications are made until the chemical can be assigned to one of the defined grades. If large volumes are applied, the lids are held closed for one minute before the animal is released.
- Concentration (if solution): 1, 5, 15, 40 or 100% - Duration of treatment / exposure:
- unrinsed
- Observation period (in vivo):
- 18 - 24 h
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:
The individual numerical scores of eye treated with a given volume or concentration of a chemical are added together and then divided by the number of eyes (usually 5) to obtain the score injury caused by the treatment. The level of 5.0 was selected as representative of severe injury. This figure corresponds to necrosis visible only after staining and covering about three fourths of the surface of the cornea; or a more severe necrosis covering a smaller area.
1) Generally the symptoms were scored as followed:
- Symptom visible before Fluorescein staining:
cornea dull: 2 points
cornea opaque, less than half of area: 4 points
cornea opaque, more than half of area: 6 points (Maximum points)
Keratoconus: 6 points (Maximum points)
Iritis, slight internal congestion: 1 point
Iritis, marked internal congestion: 2 points (Maximum points)
- Symptom visible after Fluorescein staining:
Necrosis on less than 5% of cornea: 1 point
Necrosis on 5 to 12%: 2 points
Necrosis on 13 to 37%: 3 points
Necrosis on 38 to 62%: 4 points
Necrosis on 63 to 87%: 5 points
Necrosis on 88 to 100%: 3 points (Maximum points)
- Total maximum points: 20 points
2) The injury was then graded according to the following table:
- Grade 1: 0.5 ml undiluted gives injury of 0 to 1.0 points
- Grade 2: 0.5 ml undiluted gives injury of over 1.0 up to 5.0 points
- Grade 3: 0.1 ml undiluted gives injury of up to 5.0 points (0.5 ml gives over 5.0)
- Grade 4: 0.02 ml undiluted gives injury of up to 5.0 points (0.1 ml gives over 5.0)
- Grade 5: 0.005 ml undiluted gives injury of up to 5.0 points (0.02 ml gives over 5.0)
- Grade 6: excess of 40% solution gives injury of up to 5.0 points (0.005 ml gives over 5.0)
- Grade 7: excess of 15% solution gives injury of up to 5.0 points (40% gives over 5.0)
- Grade 8: excess of 5% solution gives injury of up to 5.0 points (15% gives over 5.0)
- Grade 9: excess of 1% solution gives injury of up to 5.0 points (5% gives over 5.0)
- Grade 10: excess of 1% solution gives injury of over 5.0 points
TOOL USED TO ASSESS SCORE: the eye is examined in strong diffuse daylight, then stained with fluorescein and the injury scored
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- irritation
- Basis:
- mean
- Time point:
- other: 18-24 hours after treatment
- Score:
- 9
- Max. score:
- 10
- Reversibility:
- other: not applicable (necrosis)
- Remarks on result:
- other: The test substance was attributed to Grade 9 on a scale of 10, indicating that excess of 1% solution gives injury of up to 5.0 points (5% gives over 5.0), corresponding to necrosis on 63 to 87% of the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
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.
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