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EC number: 204-029-1 | CAS number: 113-48-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Nov 2004 to 03 Mar 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- EC Number:
- 204-029-1
- EC Name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- Cas Number:
- 113-48-4
- Molecular formula:
- C17H25NO2
- IUPAC Name:
- N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide
- Reference substance name:
- (E)-1,4-Bis(2-ethylhexylamino)-2-butene-1,4-dione
- Molecular formula:
- C20H38N2O2
- IUPAC Name:
- (E)-1,4-Bis(2-ethylhexylamino)-2-butene-1,4-dione
- Reference substance name:
- 1-(2-ethylhexyl)-1H-pyrrole-2,5-dione
- Molecular formula:
- C12H19NO2
- IUPAC Name:
- 1-(2-ethylhexyl)-1H-pyrrole-2,5-dione
- Test material form:
- liquid
- Details on test material:
- Purity and characterisation analysis conducted on the following sample; Supplier: McLaughlin Gormley King ; Batch Number: AB9500
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- MGK® 264
Lot No.: AA 7093
Purity: 95.2% MGK 264 (From CofA)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Description, Identification and Housing
Adult, New Zealand White rabbits were received from Myrtle's Rabbitry, Thompson Station, Tennessee. Upon receipt, plastic ear tags displaying unique identification numbers were used to individually identify the animals. Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals.
Environment
The animal room temperature and relative humidity ranges were 68-70°F (20-21°C) and 37-46%, respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour Iightll2-hour dark cycle and room ventilation was set to produce 10-15 air changeslhour. The animal room temperature and relative humidity were recorded a minimum of once daily.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test article was administered as received from the Sponsor.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 100% (as received)
Amount Instilled: 0.1 mL - Duration of treatment / exposure:
- Following instillation, the eyelids were gently held together for approximately one second in order to limit test article loss and the animal was returned to its cage.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- For each group, the ocular irritation score for each parameter (i.e., corneal opacity x area, iritis and conjunctival redness + swelling + discharge) was multiplied by the appropriate factor (i.e., corneal injury x 5, iritis x 5, conjunctivitis x 2) and the totals added for each animal/interval. The group mean irritation score was then calculated for each scoring interval based on the number of animals initially dosed in each group.
Ocular Observations
The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours after dosing according to the Ocular Grading System presented in Appendix 2 which is based on Draize W. Following macroscopic observations at the 24-hour scoring interval, the fluorescein examination procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this time (if possible) using physiological saline. If any fluorescein findings were noted at 24 hours, a fluorescein exam was conducted on the affected eyes at each subsequent interval until a negative response was obtained and/or until all corneal opacity had cleared, or as directed by the Study Director.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (R) Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 Hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 Hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (R) Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 Hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 Hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (R) Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 Hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 Hours
- Remarks on result:
- no indication of irritation
- Other effects:
- Animal one had a secondary occular finding of SDL (Slight dulling of normal luster of the cornea) at the 1 Hour observation. This was not noted at any other timpoints (24, 48 and 72 hr).
Any other information on results incl. tables
Based on the EEC evaluation criteria, MGK® 264 is classified as a non irritant to the ocular tissue of the rabbit for corneal opacity, iritis, conjunctival redness and conjunctival edema.
EEC Ocular Evaluation | ||||
Mean Irritation Scores in Individual Animals | ||||
Animal No./Sex | Corneal Opacity | Iris Lesion | Conjunctival Redness | Conjunctival Edema |
R2709/M | 0.00 | 0.00 | 0.67 | 0.67 |
R27101M | 0.00 | 0.00 | 1.00 | 0.33 |
R2711/M | 0.00 | 0.00 | 0.33 | 0.33 |
Irritation Rating | Nonirritant | Nonirritant | Nonirritant | Nonirritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the EEC evaluation criteria, MGK® 264 is classified as a non irritant to the ocular tissue of the rabbit for corneal opacity, iritis, conjunctival redness and conjunctival edema.
- Executive summary:
The potential irritant and/or corrosive effects of MGK® 264 were evaluated on the eyes of New Zealand White rabbits. Each of three rabbits received a 0.1 mL dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing.
Exposure to the test article produced conjunctivitis (redness, swelling, and discharge) in 3/3 test eyes at the 1h scoring interval. The conjunctival irritation resolved completely in 1/3 test eyes by the 48 -hour scoring interval and in the remaining test eyes by the 72-hour scoring interval.
Based on the Kay and Calandra evaluation criteria, MGK® 264 is considered to be a mild irritant to the ocular tissue of the rabbit.
Based on the EEC evaluation criteria, MGK® 264 is classified as a non irritant to the ocular tissue of the rabbit for corneal opacity, iritis, conjunctival redness and conjunctival edema.
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