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EC number: 223-356-0 | CAS number: 3851-87-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restriction
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : no clinical observation after 1 h
- Principles of method if other than guideline:
- The techniques of tests as published by the FDA of the US (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) are followed
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(3,5,5-trimethylhexanoyl)peroxide
- IUPAC Name:
- Bis(3,5,5-trimethylhexanoyl)peroxide
- Reference substance name:
- Bis(3,5,5-trimethylhexanoyl) peroxide
- EC Number:
- 223-356-0
- EC Name:
- Bis(3,5,5-trimethylhexanoyl) peroxide
- Cas Number:
- 3851-87-4
- Molecular formula:
- C18H34O4
- IUPAC Name:
- 3,5,5-trimethylhexanoyl 3,5,5-trimethylhexaneperoxoate
- Details on test material:
- Physical state: liquid
- Analytical purity: 75% in isododecane
- Storage condition of test material: -20°C
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- no hay or other extrageneous material that might enter the eye
- examination of of the eyes before testing
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 75% solution in isododecane
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): 75% solution in isododecane - Duration of treatment / exposure:
- as long as observation period; the eyes were not washed after treatment
- Observation period (in vivo):
- observation after 24 h, 48 h and 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: FDA scoring scale (equivalent to Draize (1944))
TOOL USED TO ASSESS SCORE: binocular
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects
Any other information on results incl. tables
Table 1: Individual scores awarded to the ocular lesions elicited by Trigonox 36-CD 75
Rabbit number |
Cornea |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
||||
After 24 hours |
|||||
25 |
1 |
0 |
2 |
2 |
|
26 |
0 |
0 |
2 |
3 |
|
27 |
0 |
0 |
1 |
2 |
|
28 |
0 |
0 |
2 |
2 |
|
29 |
0 |
0 |
2 |
3 |
|
30 |
0 |
0 |
1 |
2 |
|
After 48 hours |
|||||
25 |
0 |
0 |
1 |
0 |
|
26 |
0 |
0 |
1 |
0 |
|
27 |
0 |
0 |
1 |
0 |
|
28 |
0 |
0 |
1 |
0 |
|
29 |
0 |
0 |
1 |
0 |
|
30 |
0 |
0 |
0 |
0 |
|
After 72 hours |
|||||
25 |
0 |
0 |
0 |
0 |
|
26 |
0 |
0 |
0 |
0 |
|
27 |
0 |
0 |
0 |
0 |
|
28 |
0 |
0 |
0 |
0 |
|
29 |
0 |
0 |
0 |
0 |
|
30 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye lesions caused by Trigonox 36-CD 75 are below the threshold of classification according to regulation No. 1272/2008.
- Executive summary:
In a primary eye irritation study 100 µl of Trigonox 36-CD 75 (Bis(3,5,5 -trimethylhexanoyl)peroxide) was instilled into the everted lower lid of one eye of 6 New Zealand White albino rabbits. The eyes were not washed after instillation. Animals were observed after 24, 48 and 72 hours. Irritation was scored according the FDA scoring scale. The eye lesions were of moderate degree after 24h.and completely reversible within 72h. After 24 hours an average score of 1.67 of conjunctivae redness and an average score 2.3 of conjunctivae chemosis was observed. The mean values of the 24-48-72h readings were below the threshold of classification according to regulation No. 1272/2008 (CLP).
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