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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Some data are missing (no certificat of analysis for example), nevertheless the sutdy is sufficiently detaile for eye irritation assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Techniques of tests as published by the F.DA of the United States (Fed. R.eg.28(119), 5582, 1963) and Draize and Kelley.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
A clear colourless liquid, designated: "Tert. Amyl Hydroperoxide, batch nr. 250281" , was received from the principal on May 26, 1981.

Test animals / tissue source

Species:
rabbit
Strain:
other: White albino
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye served as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eye was examined at 24, 48, 72 hours and 7 days after instilla­
tion of the test material.
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Iris not discernable after 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Score of 3 after 7 and 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
Immediately after the instillation of the test substance the animal expressed pain by squealing.
The ocular effects after 24 hours consisted of moderate corneal opacity, slight iritis, moderate discharge of eye fluid and moderate redness and severe swelling of the conjunctivae. After seven days severe corneal opacity and deformation of the eyeball (ulcus corneae) was observed.
In addition vascularisation of the cornea was noted after 4 days.

Any other information on results incl. tables

Eye irritative effects following instillation of tert.

amylhydroperoxid into the eye of one albino rabbit.

  cornea Iris Conjunctivae score
    redness chemosis
after 1 day 2 1 2 4
after 2 days 2 1 2 3
after 3 days 2 1 3 3
after 7 days 3 1 2 1
after 14 days 3 ? 1 1

? = iris not discernable

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Tert-amyl hydroperoxide is severely irritating for eyes.
Executive summary:

The potential of tert-amyl hydroperoxide to induce ocular irritation was evaluated in a rabbit after 24 hour exposure to 0.1 ml of the substance.

Immediately after the instillation of the test substance the animal expressed pain by squealing. Due to severity of the effects, no other animal was used.

The ocular effects after 24 hours consisted of moderate corneal opacity, slight iritis, moderate discharge of eye fluid and moderate redness and severe swelling of the conjunctivae. After seven days severe corneal opacity and deformation of the eyeball (ulcus corneae) was observed.

In addition vascularisation of the cornea was noted after 14 days. Iris was not discernable after 14 days.