Registration Dossier

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: Performed according to established guidelines and good laboratory practices.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US EPA 560/6-82-001
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six adult rabbits (3 males/3 females) were acclimated 5 days prior to test initiation. Housed individually. Provided food (Wayne Rabbit Ration) and tap water ad libitum. Light cycle: 12:12 h light:dark. Eyes examined for normality prior to inclusion on test.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal (left eye) served as its own control.
Amount / concentration applied:
0.1 ml to the right eye
Duration of treatment / exposure:
72 h
Observation period (in vivo):
1, 24, 48 and 72 post-dosing. Grades of ocular reaction recorded at each examination.
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
Grading as per Draize, J.H. (1965) Appraisal of the Safety of Chemicals in Foods, Drugs adn Cosmetices - Dermal Toxcity, pg 49-52. Asociation of Food adn Drug officials of the US, Topeka, KS, and Draize, J.H. (1959), appraisal of Chemicals in Foods, Drugs adn Cosemetics, pg. 36-45. Association of Food and Drug Officials of the US, Austin, TX, and Draize, J.H., et al., (1944) J. Pharm. Exp. Ther. 82:377-390.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No positive ocular scores were recorded. The test article was determined not to be an eye irritant.

Any other information on results incl. tables

A positive reaction was considered as: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of hte normal luster), inflammation of the iris (other than a slight deepening of the rugae or light hyperemia of the cirumcorneal blood vessels), or an obivous swelling in the conjunctivae (excluding the corea and iris) with partial eversion of the eyelids adn a diffue crmoson color wiht individual vessels not easily discernible.

A positive test was defined as one with 4 or more of the animals exhibiting a positive reaction. A negative study was one with 1 or no animals exhibiting a positive reaction.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
Not an eye irritant.
Executive summary:

No positive ocular scores were recorded. The test article was determined not to be an eye irritant.