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EC number: 225-863-2 | CAS number: 5124-30-1
- 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
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- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
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- 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
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- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
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- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- e.g. non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- GLP compliance:
- no
Test material
- Reference substance name:
- 4,4'-methylenedicyclohexyl diisocyanate
- EC Number:
- 225-863-2
- EC Name:
- 4,4'-methylenedicyclohexyl diisocyanate
- Cas Number:
- 5124-30-1
- Molecular formula:
- C15H22N2O2
- IUPAC Name:
- 1,1'-methylenebis(4-isocyanatocyclohexane)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russians, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russians, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: singly in stainless steel cages
- Diet and water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye that remains untreated served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The test substance was applied into the conjunctival sac of the right eye, except for one animal where the left eye was treated; no rinsing of the eyes was done after exposure.
- Observation period (in vivo):
- Eye irritation was scored 1, 24, 48, and 72 hours and 6, 8, 10, and 14 days after start of exposure.
- Number of animals or in vitro replicates:
- 3 males / 3 females
- Details on study design:
- 0.1 mL unchanged test substance was instillated in the lower lid of one eye of each animal. No rinsing of the eyes was done after exposure. The eyes were assessed 1, 24, 48, and 72 hours and 6, 8, 10, and 14 days post-treatment.
TOOL USED TO ASSESS SCORE: sodium fluorescein / ophthalmic lamp / visual inspections
SCORING SYSTEM: Draize (Appraisals of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas, 1959, page 51)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score: 1.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score: 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score: 1.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score: 1.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score: 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #5
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: mean score: 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #4
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean score: 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: Irritation index
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 5.67
- Max. score:
- 110
- Irritant / corrosive response data:
- Mean Scores (24, 48, and 72 hours): Cornea: 0; Iris: 0, Conjunctivae (Redness): 1.28, Conjunctivae (Chemosis): 0.50
Scheme used for assessment (Irritation index, corresponding to classification as): not irritant 0-10, slightly irritant11-25, moderately irritant 26-56, severly irritant 57-110 - Other effects:
- On Day 6 inelastic eyelids were noted and on Day 10 hair loss around the eye.
Applicant's summary and conclusion
- Executive summary:
The eye irritation properties of 4,4'-methylenedicyclohexyl diisocyanate was investigated in a study according to OECD TG 405. In this study 0.1 mL of the undiluted test substance was instilled into the lower lid of each one eye of 3 female and 3 male rabbits; the untreated contralateral eye served as control. The eyes remained unrinsed and there was no removal of test substance. The animals were observed for a period of 2 weeks post application. Eye irritation was scored using the Draize scale.
The average scores at 24, 48 and 72 hours after treatment were 0 for cornea and iris, 1.28 for conjunctiva (redness), and 0.5 for chemosis. An irritation index (time points 1, 24, 48 and 72 hours) was calculated 5.67 of 110. This leads to the conclusion "not irritant" (0 -10 = not irritant) according to the scheme applied by the author. On Day 6 inelastic eyelids were noted and on Day 10 hair loss around the eye.
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