Registration Dossier
Registration Dossier
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EC number: 247-611-0 | CAS number: 26322-14-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In general the techniques of tests as published by the FDA of the United States (Fed. Reg. (119), 5582, 1963) and Draize and Kelley (Drug Cooset. Industr. 11 (1952) 36) are followed.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Dihexadecyl peroxodicarbonate
- EC Number:
- 247-611-0
- EC Name:
- Dihexadecyl peroxodicarbonate
- Cas Number:
- 26322-14-5
- Molecular formula:
- C34H66O6
- IUPAC Name:
- 1-[({[(hexadecyloxy)carbonyl]peroxy}carbonyl)oxy]hexadecane
- Details on test material:
- Perkadox 24
di-cetyl peroxydicarbonate
solid
storage at -20°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: caged individually
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye, remaining untreated, serves as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- single exposure, no washing
- Observation period (in vivo):
- The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: binocular ( text cannot be read) with UV illumination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The eye lesions caused by the test substance were of a slight degree, see table.
- Other effects:
- None
Any other information on results incl. tables
Summary of ocular lesions mean of 6 animals per group
Animal |
Effect |
Time after application |
Average 24/48/72h |
|||
24 h |
48 h |
72 h |
7 d |
|
||
7 |
Cornea Iris Redness Chemosis |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0.66 0 |
8 |
Cornea Iris Redness Chemosis |
0 0 1 1 |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 1 0.66 |
9 |
Cornea Iris Redness Chemosis |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0.66 0.33 |
10 |
Cornea Iris Redness Chemosis |
0 0 < 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 1 0.33 |
11 |
Cornea Iris Redness Chemosis |
0 0 > 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0.66 0.33 |
12 |
Cornea Iris Redness Chemosis |
0 0 < 2 1 |
0 0 1 1 |
0 0 1 0 |
0 0 0 0 |
0 0 1.33 0.66 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye lesions caused by the test substance were of a slight degree and do not require classification for eye irritation.
- Executive summary:
Eight chemical products, all organic peroxides, were examined for eye irritating properties in experiments with albino rabbits. All products examined caused ocular lesions. Based on the effects the test substance is not classified.
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