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Diss Factsheets

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
Study period:
1990-03-27 to 1990-06-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-iodo-2-propynyl butylcarbamate
EC Number:
259-627-5
EC Name:
3-iodo-2-propynyl butylcarbamate
Cas Number:
55406-53-6
Molecular formula:
C8H12INO2
IUPAC Name:
3-iodoprop-2-yn-1-yl butylcarbamate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 89115175

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Age at study initiation: adult
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: individually; in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16.1 - 21.1 °C (61 - 70 °F)
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 1990-03-27 to 1990-04-17

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.055 mg; equivalent to 0.1 mL
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
Both eyes of each animal were examined for signs of irritation at 1, 24, 48 and 72 hours and up to 21 days after dosing using the ocular irritation grading system.
Number of animals or in vitro replicates:
3 rinsing group, 6 non rinsing group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 50 mL of physiological saline (three of nine animals)
- Time after start of exposure: 30 sec

SCORING SYSTEM: according to EPA guideline

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal: #7
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal: #8
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #9
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal: #7
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal: #8
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: #9
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
No rinse group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal: #7
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal: #8
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal: #9
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
No rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21d
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
No rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
No rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
No rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
No rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
No rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal: #7
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal: #8
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal: #9
Remarks:
Rinsed group
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
No irritation was observed in the control eyes. Normal background fluorescein dye retention (stippling/mechanical abrasions) was noted in 4/9 control eyes but was not considered significant.
In the no rinse test group, exposure to the test article produced substantial injury to the ocular tissue of the rabbit. Corneal opacity was observed in 6/6 test eyes by the 24 hour scoring interval. The corneal injury was associated with corneal epithelial sloughing and further confirmed by positive fluorescein dye retention. Normal background fluorescein dye retention (stippling) was also observed in 3/6 test eyes but was not considered significant. The corneal opacity persisted in all no rinse test eyes to test termination (day 21) and was accompanied by corneal vascularization. Iritis was observed in 6/6 test eyes at 1 hour postdose and resolved in all no rinse animals by day 21. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation diminished over the test period but persisted to study day 21.
In the rinsed test group, exposure to the test article followed by a saline rinse resulted in a decrease in the severity and duration of the ocular response. In 2/3 rinsed test eyes, iritis was observed at the 1 hour postdose and resolved by 48 hours. Conjunctival irritation was also noted in these two test eyes at 1 hour postdose and resolved by day 7. In the remaining rinsed test animal, ocular responses generally resembled those noted in the rinsed test group. However, all reactions in this latter animal resolved by 21 days postdose.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the no rinse test data, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. Ocular reactions in rinsed test eyes were less severe and completely reversible by 21 days postdose.
Executive summary:

The potential eye irritant and/or corrosive effects of the test item were evaluated in New Zealand White rabbits. Each of nine animals received a 0.055 g dose (0.1 mL equivalent) 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. At 30 seconds postinstillation, both eyes of three rabbits were rinsed with 50 mL of physiological saline (rinsed group); no rinsing procedure was utilized on the six remaining rabbits (no rinse group). Test and control eyes were examined for signs of irritation for up to 21 days following dosing.

In the no rinse test group, exposure to the test article produced substantial injury to the ocular tissue of the rabbit. Corneal opacity was observed in 6/6 test eyes by the 24 hour scoring interval. The corneal injury was associated with corneal epithelial sloughing and further confirmed by positive fluorescein dye retention. Normal background fluorescein dye retention (stippling) was also observed in 3/6 test eyes but was not considered significant. The corneal opacity persisted in all no rinse test eyes to test termination (day 21) and was accompanied by corneal vascularization. Iritis was observed in 6/6 test eyes at 1 hour postdose and resolved in all no rinse animals by day 21.Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation diminished over the test period but persisted to study day 21.

In the rinsed test group, exposure to the test article followed by a saline rinse resulted in a decrease in the severity and duration of the ocular response. In 2/3 rinsed test eyes, iritis was observed at the 1 hour postdose and resolved by 48 hours. Conjunctival irritation was also noted in these two test eyes at 1 hour postdose and resolved by day 7. In the remaining rinsed test animal, ocular responses generally resembled those noted in the rinsed test group. However, all reactions in this latter animal resolved by 21 days postdose.

Based on the no rinse test data, the test item is considered to be a severe irritant to the ocular tissue of the rabbit.As noted above, ocular reactions in rinsed test eyes were less severe and completely reversible by 21 days postdose.