2,6-xylenol

Eye irritation

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 for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

2,6 xylenol

IUPAC Name:

2,6 xylenol

Constituent 2

Reference substance name:

2,6-xylenol

EC Number:

209-400-1

EC Name:

2,6-xylenol

Cas Number:

576-26-1

Molecular formula:

C8H10O

IUPAC Name:

2,6-dimethylphenol

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

Results

Results 1

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.

Results 2

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.

Results 3

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.

Results 4

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.