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EC number: 222-321-7 | CAS number: 3425-61-4
Eye irritation
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:
- 1 981
- 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 substance name:
- tert-pentyl hydroperoxide
- EC Number:
- 222-321-7
- EC Name:
- tert-pentyl hydroperoxide
- Cas Number:
- 3425-61-4
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-methylbutane-2-peroxol
- 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.
Constituent 1
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.
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