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EC number: 905-588-0 | CAS number: -
Eye irritation
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:
- 1 983
- 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 substance name:
- o-xylene
- EC Number:
- 202-422-2
- EC Name:
- o-xylene
- Cas Number:
- 95-47-6
- Molecular formula:
- C8H10
- IUPAC Name:
- o-xylene
- Details on test material:
- no further details
Constituent 1
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.
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