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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:
october-december 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: test substance not identified (indicated by C-121); The study duration was 72 hours; the observation period was not untill reversibility of the effects observed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
16 CFR Part 1500.42
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C-121
- Physical state: liquid
- 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: Dutchland Laboratory Animals, Inc., Denver, PA
- Weight at study initiation: young adult, 3.1 to 4.0 kg
- Housing: Individual in suspended stainless steel cages.
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): Elizabethtown Water Co., ad libitum
- Acclimation period: two weeks

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the controlateral eye serves as the control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
0.1 mL of the liquid test substance, at room temperature, is introduced into the lower conjunctival sac of one eye of each animal. The upper and lower lids are gently held together for one second prior to releasing to prevent loss of material.
viability check: twice daily
intervals of eye irritation evaluation: 24, 48, 72 hours
At each interval the treated eyes are examined and scored for ocular reactions according to Draize scales. Fluorescein dye is used starting with 24 hour observation and at each subsequent observation. Unusual effects, such as pannus, blistering of the conjunctiva, ulceration and other effects indicative for corrosive action are reported separately

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
0 - <= 4
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72h
Score:
0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72h
Score:
0 - <= 3
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritant / corrosive response data:
Positive scores for conjunctival redness were exhibited by all animals. Five animals showed positive scores for corneal ulceration and four animals showed corneal opacities and iridial irritation. One animal exhibited a positive score for conjunctival chemosis. All eyes showed signs of irritation at termination of the study at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
irritating
Conclusions:
irritating
Executive summary:

Positive scores for conjunctival redness were exhibited by all animals. Five animals showed positive scores for corneal ulceration and four animals showed corneal opacities and iridial irritation. One animal exhibited a positive score for conjunctival chemosis. All eyes showed signs of irritation at termination of the study at 72 hours. Based on these results, the substance is considered to be irritating to the eyes.