Registration Dossier
Registration Dossier
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EC number: 252-029-5 | CAS number: 34443-12-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- EC Number:
- 252-029-5
- EC Name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- Cas Number:
- 34443-12-4
- Molecular formula:
- C13H26O4
- IUPAC Name:
- 3-({[(tert-butylperoxy)carbonyl]oxy}methyl)heptane
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman institute, Someren, The Netherlands
- Age at study initiation:
- Weight at study initiation: 7 months
- Housing: in Lurane cages
- Diet and water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-75
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL was applied in the conjunctival sac of the right eye, the other eye served as control.
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : no
SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE: fluorescein 2% , 24 hours after tratment. in one animal, this treatment was repeated on day 10.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0 - 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0 - 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
Any other information on results incl. tables
| Observation time after exposure | Corneal Opacity | Iris lesion | Conjunctival redness | Conjunctival swelling (chemosis) | Mean corneal opacity (24/48/72 hours) | Mean iris lesion score (24/48/72 hours) | Mean Conjunctival redness score (24/48/72 hours) | Mean Conjunctival swelling (24/48/72 hours) | |
| Rabbit 1 | 1 h | 0 | 0 | 1 | 1 | 0,3 | 0 | 0,3 | 0 |
| 24 h | 1d | 0 | 1 | 0 | |||||
| 48 h | 0 | 0 | 0 | 0 | |||||
| 72 h | 0 | 0 | 0 | 0 | |||||
| 10 days | 0 | 0 | 0 | 0 | |||||
| Rabbit 2 | 1 h | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0,3 |
| 24 h | 0 | 0 | 1 | 1 | |||||
| 48 h | 0 | 0 | 1 | 0 | |||||
| 72 h | 0 | 0 | 1 | 0 | |||||
| 10 days | 0 | 0 | 0 | 0 | |||||
| Rabbit 3 | 1 h | 0 | 0 | 1 | 1 | 0 | 0 | 0,6 | 0,3 |
| 24 h | 0 | 0 | 1 | 1 | |||||
| 48 h | 0 | 0 | 1 | 0 | |||||
| 72 h | 0 | 0 | 0 | 0 | |||||
| 10 days | 0 | 0 | 0 | 0 |
d: Fluorescein treatment revealed damage of 1 % of the corneal surface which was totally reversible for 10 days
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TBEC was very sligthly irritating when administered by ocular route to rabbits.
- Executive summary:
The potential of TBEC to induce ocular irritation was evaluated in rabbits in a test similar to OECD 405 guideline.
TBEC was administered undiluted to 3 New Zealand White rabbits in the conjunctival sac of one eye. 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 1 hour, 24, 48 and 72 hours and 10 days after the administration. The mean values of the scores for corneal opacity chemosis, redness of the conjunctiva, iris lesions were calculated for each animal.
Only minor signs of irritation were observed. For one animal, fluorescein treatment revealed damage of 1 % of the corneal surface which was totally reversible for 10 days.
Under these experimental conditions, TBEC was therefore very slightly irritating when administered by ocular route to rabbits.
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