Registration Dossier

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: Study was conducted in methods comparable to OECD guideline 405. However, study was terminated at 72 hours after application. The reversibility of effects after 21 days could not be evaluated.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Study was terminated at 72 hours after application, the reversibility of the effects after 21 days could not be evaluated.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6-xylenol
- Physical state: white solid
- Analytical purity: The material was considered to be free of impurities.
- Other: received on April 19, 1965. The test substance has a pungent odor.

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.1 to 2.9 kg
- Housing: Throughout the study animals were individually housed in metal cages.
- Diet: Purina rabbit pellets were freely available at all time.
- Water: Water was freely available at all time.
- Other: Prior to application, the left eye of each rabbit was examined with 2.0% sodium fluorescein solution to detect any corneal lesions not otherwise visible, and only those animals with eyes free of irritation and corneal damage were used in this study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: A single application of 100 mg of the undiluted test substance was made into the conjunctival sac of the left eye of each animal.
Duration of treatment / exposure:
Single application. The treated eye was held closed for 30 seconds following application.
Observation period (in vivo):
The animals were observed for signs of eye irritation and systemic toxicity at 24, 48, and 72 hours after application.
Number of animals or in vitro replicates:
Six
Details on study design:
SCORING SYSTEM: The signs of eye irritation were graded and recorded according to the numerical scoring system of Draize, J.H., from the Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Assn. of Food and Drug Officials of the U.S., Austin, Texas, 1959.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 24, 48 and 72 hours after installation of the test material
Score:
1.8
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: All six animals had mean corneal opacity scores of ≥ 1 following grading at 24, 48 and 72 hours after installation.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after installation of the test material
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: All six animals had mean iris scores of 1 following grading at 24, 48 and 72 hours after installation.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours after installation of the test material
Score:
2.9
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: All six animals had mean conjunctivae redness scores of ≥ 2 following grading at 24, 48 and 72 hours after installation.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after installation of the test material
Score:
1.8
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Remarks on result:
other: Four of six animals had mean chemosis scores of 2 following grading at 24, 48 and 72 hours after installation.
Irritant / corrosive response data:
The irritation was severe and consisted of marked conjunctival irritation, slight iritis, corneal opacity, and corneal sloughing in all treated eyes at 24, 48, and 72 hours after eye installation. The fluorescein examination at 72 hours confirmed the presence of corneal damage in all six animals. The effects were not reversible.
Other effects:
All animals seemed normal in appearance and behavior throughout the study and showed normal body weight gains.

Applicant's summary and conclusion

Interpretation of results:
other: Category 2
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
A single application of 100 mg of 2,6-xylenol to the eyes of albino rabbits produced severe conjunctival irritation, iritis, corneal opacity, and sloughing in rabbits at 24, 48, and 72 hours after application. The test substance is therefore considered to be an eye irritant based on the results of this study.