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EC number: 203-583-1 | CAS number: 108-44-1
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:
- other: Although scores were not given, reporting is sufficient to assess the test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Method: 2 animals, instillation of 0.1 ml undiluted test material into conjunctival sac, observation period up to 14 d
- GLP compliance:
- not specified
Test material
- Reference substance name:
- m-toluidine
- EC Number:
- 203-583-1
- EC Name:
- m-toluidine
- Cas Number:
- 108-44-1
- Molecular formula:
- C7H9N
- IUPAC Name:
- 3-methylaniline
- Details on test material:
- IUCLID4 Test substance: other TS: m-toluidine, purity >98.5%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite eye served as control
- Amount / concentration applied:
- one-tenth milliliter
- Duration of treatment / exposure:
- the test-eye of 1 rabbit was washed after 20 seconds; the other test-eye of the second rabbit was not washed
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- one-tenth milliliter of undiluted test material was placed into the right concunctival sac of each of 2 male albino rabbits.
after 20 seconds 1 treated eye was wached with tap water for 1 minutes. the treated eye of the other rabbbit was not washed.
Observations of the cornea, iris and concunctiva were made with an ophthamoscope at 1 and 4 hours and at 1, 2, 3, 7 and 14 days ;
Fluor-1 -strip stin and a slit-lamp biomicroscope were used at examinations after the day of treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: overall irritation
- Basis:
- animal #1
- Time point:
- other: overall
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: eye not washed:----- cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs
- Irritation parameter:
- other: overall irritation
- Basis:
- animal #2
- Time point:
- other: overall
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: eye washed: -cornea: generalised slight cloudiness up to 7 days; penetrating injury 1-7 days, vascularisation in lower parts of cornea at 7 days; -iris: no effect; -conjuctiva; slight redness (day 3), slight swelling (day 3).slight discharge (day3)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: generalized area of slight cloudiness 1hr- 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: redness mild 1 hr-3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: swelling: mild 1-4 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: generalised slight cloudiness up to 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: slight redness (day 3)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: slight swelling (day 3)
- Irritant / corrosive response data:
- animal 1: not washed-----effects fully reversible within 7 days
cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs - Other effects:
- animal 1: not washed-----effects fully reversible within 7 days
cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs
Any other information on results incl. tables
animal 1: not washed-----effects fully reversible within 4 days
cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs
animal 2: eye washed: -cornea: generalised slight cloudiness up to 7 days; penetrating injury 1-7 days, vascularisation in lower parts of cornea at 7 days; -iris: no effect; -conjuctiva; slight redness (day 3), slight swelling (day 3), slight discharge (day3).
Thus, the test material produced temporary slight to mild occular effects with transient copious discharge
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Executive summary:
The test material produced temporary mild to slight occular effects with transient copious discharge: As these effects were fully reversible within the observation period of 14 days the test material was evaluated to be slightly irritating to the eyes of rabbits (DuPont De Nemours 1980), with observations not relevant for classification
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