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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
Study period:
From Feb 19, 1990 to Feb 26, 1990
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): MON 13900
- Substance type: Brown particles (powder)
- Lot/batch No.: DAY-8912-1370T
- Expiration date of the lot/batch: December, 1993 (estimated)
- 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:
Six adult New Zealand White rabbits (1 male, 5 females) obtained from Mohican Valley Rabbitry, Loudonville, Ohio, were used in this study. The animals were individually housed in suspended stainless steel cages in an environment-controlled room with a 12–h light/dark cycle. Agway Prolab rabbit ration and fresh water were provided to each animal ad libitum. The rabbits were individually identified using plastic ear tags and cage cards. All animals were acclimated to the laboratory environment for a minimum of 5 d prior to initiation of the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.047 g (0.1 mL equivalent)
Duration of treatment / exposure:
Once
Observation period (in vivo):
1, 24, 48 and 72 h and up to Day 7
Number of animals or in vitro replicates:
6
Details on study design:
Animals were weighed prior to the initiation of the study (body weights ranged from 2.3-2.6 kg). Within 24 h prior to the start of the study, both eyes of each animal provisionally selected for testing were examined macroscopically for ocular irritation with the aid of an auxillary light source. In addition, the corneal surface was examined using fluorescein sodium dye. Fluorescein dye was instilled into each eye. Following a 15 sec exposure, the eyes were thoroughly rinsed with physiological saline. The corneal surface was then examined for dye retention under a long-wave UV light source. Only those animals which showed no signs of eye irritation, ocular defects or pre-existing corneal lesions were used. A dose of 0.047 g (0.1 mL equivalent) of the test substance was instilled into the conjunctival sac of the right eye of each animal. Immediately after dosing, the eyelids were gently held together for approx 1 sec. The contralateral eye of each rabbit remained untreated and served as the control for that animal. Both eyes of each animal were examined for signs of irritation at 1, 24, 48 and 72 h and up to Day 7 after dosing using the ocular irritation grading system. Following macroscopic observations at the 24 h scoring interval, the fluorescein examination procedure was repeated on all test and control eyes. If positive fluorescein dye retention was noted at 24 h (other than normal background retention or mechanical abrasions), a fluorescein exam was conducted on the affected eyes at each subsequent interval until a negative response was obtained.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, 2 and 6
Time point:
other: 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal: #4 and 5
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal: #1, 5 and 6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Exposure to the test substance produced iritis in 6/6 test eyes at the 1 h scoring interval. The iridal irritation resolved in all animals by 24 h postdose. Conjunctivitis (redness, discharge and/or swelling) was noted in 6/6 test eyes at the 1 h scoring interval. The conjunctival irritation diminished over the test period and resolved in all animals by study Day 7.

Any other information on results incl. tables

Refer to the attached document under 'attached background material'.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, MON 13900 is considered to be a mild irritant to the ocular tissue of the rabbit.
Executive summary:

The potential eye irritation and/or corrosion effects of MON 13900 were evaluated in New Zealand White rabbits according to the EU Method B.5, EPA OPP 81-4 and OECD Guideline 405 in compliance with GLP.

Each of six animals received a 0.047 g dose (0.1 mL equivalent) of the test substance in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Exposure to the test substance produced iritis in 6/6 eyes at the 1 h scoring interval. The iridal irritation resolved by 24 h post-dose. Conjunctivitis (redness, discharge and/or swelling) was noted in 6/6 eyes at the 1 h scoring interval. The conjunctival irritation diminished over the test period and resolved in all animals by study Day 7.

Under the conditions of this study, the test substance is considered to be a mild irritant to the ocular tissue of rabbit.