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EC number: 800-300-9 | CAS number: 83447-96-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted in compliance with GLP and according to the OECD guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trans-1,4-bis(iodomethyl)cyclohexane
- Cas Number:
- 83447-96-5
- Molecular formula:
- C8H14I2
- IUPAC Name:
- trans-1,4-bis(iodomethyl)cyclohexane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3053 - 3498 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.5°C
- Humidity (%): 30-45%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 100 mg of the test item were instilled into the conjunctival sac of one eye of each animal. The treated eyes were rinsed out with deionised water to remove the solid test item particles from the eyes of all animals one hour after instillation, carefully.
- Observation period (in vivo):
- 60 minutes, 24, 48 and 72 hours after installation of the test item
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The test was carried out with three male rabbits. Both eyes of each animal were examined approximately 24 hours before testing. Two to three
drops of a fluorescein sodium solution (0.5 % in deionised water) were instilled into the conjunctival sac and rinsed out again after 30 sec with
deionised water. No ocular defects were observed in any of the animals.
100 mg of the test item were instilled into the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball.
The lids were then held together gentIy for approximately 1 second in order to prevent loss of the material. The other eye of the same animal, which
remained untreated, served as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 1 day (redness)
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 1 day (only 1 animal affected)
- Irritant / corrosive response data:
- One day after instillation signs of irritations were not more observed.
- Other effects:
- The instillation of the test item caused only a slight redness of the conjunctivae in all animals and a slight swelling of the conjunctivae in one animal
one hour after instillation. The cornea and the iris were not affected.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with the results of this study and in compliance with the criteria of Appendix 6 to Directive 2001/59/EU of August 06, 2001 P2 may
be classified as a substance that is non-irritant to the eye. - Executive summary:
Only conjunctivae redness grade 1 was observed in all 3 animals at 1 hour after administration. Approx. 24 hours after administration this alteration was no longer observed and therefore fully reversible. In 1/3 animals additionally conjunctivae chemosis grade 1 was noted at 1 hours after administration and was also no longer noted 24 hours later. Based on the results of this study it can be concluded the the test substance has not irritating potential for the eyes and hence does not have to be classified.
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