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EC number: 210-382-2 | CAS number: 614-45-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 hours
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Because the purity of the substance tested is not given in the study report, it is not possible to ascertain the degree to which the results represent the pure submission substance.
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:
- 614-45-9 (% unknown)
- IUPAC Name:
- 614-45-9 (% unknown)
- Reference substance name:
- tert-butyl perbenzoate
- EC Number:
- 210-382-2
- EC Name:
- tert-butyl perbenzoate
- Cas Number:
- 614-45-9
- Molecular formula:
- C11H14O3
- IUPAC Name:
- tert-butyl benzenecarboperoxoate
- Details on test material:
- A 250 g sample of the test substance was received from the sponsor on December 11, 1985. It was a clear, colourless, slightly viscous liquid, designated Trigonox C, no. 4285060690, and it was stated to be t. butylperbenzoate.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Healthy male, young adult, New Zealand White albino rabbits obtained from ENKI-Konijnenfarm, Someren, the Netherlands, were used as the experimental animals. The body weight range was 2500-3500 g. The animals were identified by earmarking.The animals were housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front. The cages were placed in a room, controlled for light (12 hours light/dark cycle), temperature (18+/-3°C), ventilation (c. 10 air changes/hour), and relative humidity (40-70%) throughout the test period. A standard laboratory rabbit diet and tap water were provided ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each animal served as control
- Amount / concentration applied:
- 0.1 ml - One tenth of a milliliter of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit.
- Duration of treatment / exposure:
- After administration the upper and lower lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Both eyes of each rabbit provisionally selected were examined within 24 hours before testing; three animals without observable eye defects were used. One tenth of a milliliter of the undiluted test substance was allowed tofall on the everted lower lid of one eye of each rabbit. After administration the upper and lower lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The eyes were not washed out following administration and the animals were released immediately. Ocular reactions were judged using a scoring scale which is part of the attached complete report. Eye effects were examined after one hour, 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Irritant / corrosive response data:
- maximum score, any animal @ 1, 48 and 72 hours, respectively: 2*, 1*, 0
*chemosis and redness - Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance caused slight or moderate redness and slight or moderate swelling of the conjunctivae in all (three) rabbits. After 72 hours, all eye effects had cleared completely. On the basis of the results obtained it was concluded that, according to the EEC-standards*, the undiluted test substance Trigonox C is not an eye irritant.
*EEC Directive 79-831, Annex V, Methods for the determination of toxicity, B.5. Acute toxicity, eye irritation, dated December 1983. - Executive summary:
The test substance caused slight or moderate redness and slight or moderate swelling of the conjunctivae in all (three) rabbits. After 72 hours, all eye effects had cleared completely. On the basis of the results obtained it was concluded that, according to the EEC-standards*, the undiluted test substance Trigonox C is not an eye irritant.
*EEC Directive 79-831, Annex V, Methods for the determination of toxicity, B.5. Acute toxicity, eye irritation, dated December 1983.
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