Registration Dossier
Registration Dossier
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EC number: 212-092-1 | CAS number: 762-12-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: US Fed.Reg. 28 (119), 5582, 1963
- GLP compliance:
- no
Test material
- Reference substance name:
- Bisdecanoyl peroxide
- EC Number:
- 212-092-1
- EC Name:
- Bisdecanoyl peroxide
- Cas Number:
- 762-12-9
- Molecular formula:
- C20H38O4
- IUPAC Name:
- decanoyl decaneperoxoate
- Test material form:
- solid: compact
- Details on test material:
- - Physical state: White powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- caged individually
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- No washed
- Observation period (in vivo):
- eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- SCORING SYSTEM: the FDA-scoring scale was used to grade the severity of eye reactions.
positive reactions were: opacity of the cornea, ulceration of the cornea, inflammation of the iris, slight circumcorneal injection or if such substances produce in the conjunctivae an obvious swelling with partial eversion of the lids, a diffuse deep-crimson red with individual vessels not easily discernable.
The test was considered positive if four or more of the animals in the test group of 6 rabbits exhibit a positive reaction.
If two or three animals exhibited a positive reaction, the test is repeated.
reading materials: binocular magnifying glass; diagnostic of corneal damages : staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Didecanoyl peroxide was not considered to be eye irritant.
- Executive summary:
The potential of didecanoyl peroxide to induce ocular irritation was evaluated in rabbits following a technique similar to OECD 405 guideline.
A single dose of 100 mg of pure substance was instilled into the conjunctival sac. The other eye was not treated and served as control. The eyes were not rinsed after administration of the test item.
Ocular reactions were observed approximately 24, 48, 72 hours and 7 days after the administration. The scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.
Scores calculated for each animal over 24, 48 and 72 hours were 0 for cornea and iris, and 0 or 1 for redness and chemosis of the cunjonctivae. Otherwise all signs were fully reversible within 7 days.
Under these experimental conditions, didecanoyl peroxide was slightly irritating when administered by ocular route to rabbits.
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