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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 405 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. 1.3. and 4.1.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The rabbits were acquired from Rich-Glo II, Inc; Wills Point, Texas and weighed approximately 3.5 kilograms at study initiation. The animals were housed in suspended, wire bottom, stainless steel cages, 1 per cage. The animal room was maintained at 19-23°C with a relative humidity of 37-96% and a 12-hour light/dark cycle with 10-12 air changes/hour. The animals were provided PMI Feeds, Inc.°’ Lab Rabbit Diet #532 1. ~8 oz. dailyand Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system.




Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
One
Details on study design:
Only one animal was placed on study due to the apparent corrosive nature of the test substance and a measured pH of 11.0. On Day 0, a dose of 0.1 mL of the undiluted test substance was placed into the conjunctival sac of the right eye of the animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. Prior to dosing, both eyes were anesthetized with Tetracaine ophthalmic solution . The lids were gently held together for one second to prevent loss of material. The untreated left eye served as a comparative control.

The treated eye was examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures, and (if needed) an additional source of white light affixed to the examination table or using a handheld flashlight. The grades of ocular reaction were recorded at 1,24, 48 and 72 hours, and at 4, 7, 10, 14, 17 and 21 days after treatment. The cornea of the treated eye was examined immediately after the
24-hour observation with a fluorescein sodium ophthalmic solution. A Finoff ocular transilluminator with cobalt blue filter was utilized to enhance visualization of fluorescein staining. Since the cornea exhibited fluorescein staining at the 24-hour observation, it was re-examined with the fluorescein sodium ophthalmic solution at each consecutive observation until fluorescein staining of the cornea no longer occurred. The treated eye was washed with room temperature DI water for one minute immediately after recording the 24-hour observation.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #1
Time point:
other: 14 days
Score:
ca. 88
Max. score:
88
Reversibility:
not reversible
Remarks on result:
other: Corneal opacity and area reached a maximum of 4 at day 14. Fluorescein staining was observed at 24 hours after treatment and persisted through Day 21 after treatment.
Irritant / corrosive response data:
The maximum average irritation score of 88 0, obtained 14 days after treatment, was used to rate the test substance extremely irritating. Fluorescein staining was observed at 24 hours after treatment and persisted through Day 21 after treatment. Maximum corneal opacity of grade 4 was oberved on days 14, 17 and 21. Maximum corneal area involvement was observed on post treatment days: 1, 2, 3, 4, 10 and 14.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance is judged to be Extremely irritating/corrosive to the rabbit eye based on the outcome of one animal.
Executive summary:

The test substance, Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol was evaluated for eye irritation potential in an O.E.C.D. test guideline 405 study with one animal. The test substance is judged to be Extremely irritating/corrosive to the rabbit eye based on the outcome of the one animal.