Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Two drops of material was instilled into the right eye and then washed (within 30 s) with a flowing stream of tepid water for 2 minutes. The left eye was treated the same but was left unwashed. Observations were made within 2-3 minutes, at 1, 24, and 48 hours and 6 to 8 days after treatment.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Industrial Grade Diphenyl Oxide
Reference No.: XA-1075-L
Appearance: light yellow liquid

Test animals / tissue source

Species:
other: Although not specified, rabbits were typically used for this study.
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2 drops of undiluted material/eye
Duration of treatment / exposure:
Single exposure
Right eye was washed after 30 s of exposure, left eye was left unwashed
Observation period (in vivo):
Observed immediately for pain. Observations for conjunctival and corneal responses were made within 2-3 minutes, at 1, 24, and 48 hours and 6-8 days.
Number of animals or in vitro replicates:
3
Details on study design:
No additional information

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: immediate (2-3 minutes)
Score:
2
Max. score:
6
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
6
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h, 48 h and 7 days
Score:
1
Max. score:
6
Remarks on result:
other: washed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: immediate (2-3minutes)
Score:
1
Max. score:
6
Remarks on result:
other: washed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
1.67
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
1.3
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
2
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed and after stain
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: immediate (2-3 minutes)
Score:
1
Max. score:
6
Remarks on result:
other: not washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
6
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: not washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 and 48 h and 7 days
Score:
1
Max. score:
6
Remarks on result:
other: not washed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: immediate (2-3 minutes)
Score:
1
Max. score:
6
Remarks on result:
other: not washed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
1.67
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
1.3
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
1.67
Max. score:
6
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not washed and after stain
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: All time points
Score:
1
Max. score:
6
Remarks on result:
other: Before stain, washed and unwashed
Irritant / corrosive response data:
Pain response was a 2 out of 6 or very slight (time point- immediate).
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Eye contact with the test material would likely result in very slight pain, very slight transient conjunctival inflammation, and possibly a slight transient corneal injury.
Executive summary:

A sample of industrial grade diphenyl oxide XA-1075-L, was submitted to Chemical Biology Research for evaluation of acute oral lethality, eye and skin irritation properties, and for definition of industrial handling hazards involving acute exposures. The test material is in the early stages of application development. The objective of this study was to provide initial toxicological information on the industrial grade material. As applications are developed, additional appropriate toxicological tests may be required.

Eye contact with the test material would likely result in very slight pain, very slight transient conjunctival inflammation, and possibly a slight transient corneal injury. Safety glasses are recommended whenever the likelihood of eye contact exists.