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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study, GLP status not known, animal experimental study, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
unwashed eye
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no further details

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
no data
Duration of treatment / exposure:
1 h (not confirmed)
Observation period (in vivo):
1, 24, 48 and 72 hours, 4 and 7 days post instillation
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
no further details

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
6
Max. score:
10
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Conjunctival redness (vessels definitely injected above normal to more diffuse, deeper crimson red, individual vessels not easily discernible) was noted in all 6 rabbits at 1 h post instillation of o-xylene. Conjunctival chemosis (swelling above normal) and conjunctival discharge (any amount above normal) were noted in 5 rabbits at 1 h post instillation. Phonation at instillation was noted in 4 rabbits. No corneal opacity or iritis was noted in any of the 6 rabbits. All ocular lesions had cleared by Day 7.

Any other information on results incl. tables

Eye Irritation Score Ranges and Means with Standard Deviations

Observation

Hours

Days

1

24

48

72

4

7

Cornea

 

 

 

 

 

 

Mean

0.0

0.0

0.0

0.0

0.0

0.0

S.D.

0.0

0.0

0.0

0.0

0.0

0.0

Range

-

-

-

-

-

-

Iris

 

 

 

 

 

 

Mean

0.0

0.0

0.0

0.0

0.0

0.0

S.D.

0.0

0.0

0.0

0.0

0.0

0.0

Range

-

-

-

-

-

-

Conjunctivae

 

 

 

 

 

 

Mean

6.0

1.7

1.3

1.3

1.0

0.0

S.D.

2.2

0.8

1.6

1.6

1.1

0.0

Range

2-8

0-2

0-4

0-4

0-2

-

Total Score

 

 

 

 

 

 

Mean

6.0

1.7

1.3

1.3

1.0

0.0

S.D.

2.2

0.8

1.6

1.6

1.1

0.0

Range

2-8

0-2

0-4

0-4

0-2

-

Means based on six observations.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Executive summary:

Conjunctival redness (vessels definitely injected above normal to more diffuse, deeper crimson red, individual vessels not easily discernible) was noted in all 6 rabbits at 1 h post instillation of o-xylene. Conjunctival chemosis (swelling above normal) and conjunctival discharge (any amount above normal) were noted in 5 rabbits at 1 h post instillation. Phonation at instillation was noted in 4 rabbits. No corneal opacity or iritis was noted in any of the 6 rabbits. All ocular lesions had cleared by Day 7.