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Toxicological information

Eye irritation

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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:
1980
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

Constituent 1
Chemical structure
Reference substance name:
m-toluidine
EC Number:
203-583-1
EC Name:
m-toluidine
Cas Number:
108-44-1
Molecular formula:
C7H9N
IUPAC Name:
m-toluidine
Details on test material:
IUCLID4 Test substance: other TS: m-toluidine, purity >98.5%

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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