Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
according to: Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Epoxide No. 8

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-No details given

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Undiluted (No Rinse) - 0.1 ml
Observation period (in vivo):
7
Number of animals or in vitro replicates:
3
Details on study design:
Test Method
All eyes are examined prior to testing and only those that are grossly normal are used in eye irritation studies. The test material is placed into the
conjunctival sac of one eye of an albino rabbit, while the remaining eye serves as control.
Three eyes are treated for each test group. No rinsing was done.
Scoring of Eye Irritation
Eyes are scored at one hour; one, two, three, four and seven days; then weekly thereafter for a maximum of five weeks. Scoring may be discontinued at any time during the observation period if there is no gross evidence of any irritation to the ocular tissue or if the damage is so severe that
there is no hope for improvement. The scale for scoring ocular lesions is performed according to the method of Draize (1).
Aids for visual observation of corneal involvement include fluorescein staining, magnification by binocular head band and/or use of the Concept
Cobalt Blue Slit-Beam Light (Model 022). For more detailed observation, a Haag~Streit Slit Lamp Biomicroscope is utilized. .
Our scoring method differs from that recommended by the FDA (2) in that slight dulling (bedewing) and/or stippling, of the cornea is recorded 'as a grade 0.5 in our method. The' end result is that our scoring system results in slightly higher Maximum Average Scores (MAS) than would be expected if one adhered to the FDA Guidelines. MAS is the highest average score observed on any given day for the three animals in a given test group, regardless of the time required to produce these scores.

(1) Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
(2) Illustrated Guide for Grading Eye Irritation by Hazardous Substances, U.S. Dept. ·of Health, Education, and Welfare, Food & Drug Administration
Test Method
All eyes are examined prior to testing and only those that are grossly normal are used in eye irritation studies. The test material is placed into the
conjunctival sac of one eye of an albino rabbit, while the remaining eye serves as control.
Three eyes are treated for each test group. No rinsing was done.

Scoring of Eye Irritation
Eyes are scored at one hour; one, two, three, four and seven days; then weekly thereafter for a maximum of five weeks. Scoring may be discontinued at any time during the observation period if there is no gross evidence of any irritation to the ocular tissue or if the damage is so severe that there is no hope for improvement. The scale for scoring ocular lesions is performed according to the method of Draize (1).
Aids for visual observation of corneal involvement include fluorescein staining, magnification by binocular head band and/or use of the Concept Cobalt Blue Slit-Beam Light (Model 022). For more detailed observation, a Haag-Streit Slit Lamp Biomicroscope is utilized. .

The scoring method differed from that recommended by the FDA (2) in that slight dulling (bedewing) and/or stippling, of the cornea is recorded 'as a grade 0.5 in this method. The end result is that this scoring system results in slightly higher Maximum Average Scores (MAS) than would be expected if one adhered to the FDA Guidelines. MAS is the highest average score observed on any given day for the three animals in a given test group, regardless of the time required to produce these scores.

(1) Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
(2) Illustrated Guide for Grading Eye Irritation by Hazardous Substances, U.S. Dept. •of Health, Education, and Welfare, Food & Drug Administration

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Material

Treatment

Mean Average Score

Corneas involved

Eyes Normal

(In Indicated

Number of

Days)

Epoxide No. 8

Undiluted (NR)

2.0

0/3

3 (1 day)

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
Epoxide No. 8 would be classified as minimally irritating to the rabbit eye according to the classification described by John H. Kay and
Joseph C. Calandra, "Interpretation of Eye Irritation Tests" , J. Soc. Cosmet. Chem. 13, 281-289, 1962. Since the rabbit eye is'considerably more sensitive to foreign materials' than the human eye, Epoxide No.8 is expected to be non-irritating in case of accidental spilling or splashing into the
human eye.
Executive summary:

Undiluted Epoxide No. 8 ( 0.1 ml) was placed in the conjunctival sac of one eye of an albino rabbit (three animlas in each group), while the remaining eye served as control. Eyes were scored at one hour; and one day according to Draize. The study and scoring was discontinued since there was no gross evidence of any irritation to the ocular tissue

Undiluted Epoxide No. 8 produced very slight conjunctivitis which cleared readily within 24 hours.