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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
EC Number:
700-641-2
Cas Number:
1261240-30-5
Molecular formula:
C37H46O5
IUPAC Name:
4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
Test material form:
other: Crystalline powder
Details on test material:
Name: Revonox 501
Lot/Batch No.: S25211603
Major ingredients: 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl3,5-di-tert-butyl-4-hydroxybenzoate
Purity of active ingredients: 99-100% min
Physical feature: No sterilization, white crystalline powder, no odour

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: Hui-Jun Grazing
Quality: Clean Conventional
Gender: Male
Justification for selection: The NZW rabbit is widely used and accepted by Health Authorities as an appropriateexperimental animal.
Age and body weight: At study initiation, animals were approximately 5 months old, with the study weights range of 2.3 - 2.7 kg prior to dosing.
Animal amount: 3 male rabbits
ENVIRONMENTAL CONDITIONS
Temperature: 20+/-3 degree C
Relative humidity: 50+/-20%
Light cycle: 12 hours light and 12 hours dark
Diet: Labdiet, Prolab Rabbit Diet 5P26 was supplied approximately 50 g/kg daily throughout the study period.
Water: RO water was supplied ad libitum via water bottles attached to the cages.
Rabbits were housed in stainless steel cages (One rabbit/cage).

Test system

Vehicle:
not specified
Controls:
other: Untreated left eye was used as control.
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
INITIAL TEST
Animal amount: 1; Control (untreated): Left eye; Test substance treated: Right eye
CONFIRMATORY TEST
Animal amount: 2; Contraol (untreated): Left eye; Test substance treated: Right eye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(Animal I.D. A111100311001)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No conjunctivae redness effect was observed during the study.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(Animal I.D. A111100311002)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No conjunctivae redness effect was observed during the study.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(Animal I.D. A111100311003)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No conjunctivae redness effect was observed during the study.
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(Animal I.D. A111100311001)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(Animal I.D. A111100311002)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(Animal I.D. A111100311003)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(Animal I.D. A111100311001)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No corneal effect was observed during the study.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(Animal I.D. A111100311002)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks:
The reversibility was noted at 24 hours after treatment. No corneal redness effect was observed during the study.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(Animal I.D. A111100311003)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No corneal effect was observed during the study.
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(Animal I.D. A111100311001)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No iridial effect was observed during the study.
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(Animal I.D. A111100311002)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No iridial effect was observed during the study.
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(Animal I.D. A111100311003)
Time point:
24/48/72 h
Score:
0
Reversibility:
other: The reversibility was noted at 24 hours after treatment. No iridial effect was observed during the study.

Any other information on results incl. tables

Mortality/Moribundity: No animal death was observed during the study period.

CLinical Observation: No abnormal clinical signs were observed during the observation period.

Individual Animal Body Weights: Individual animal body weights were recorded on the Day 1 (before dosing) and at the end of the observation period (Day 4). The body weights of rabbits were no abnormal decrease noted during the study period.

Individual Animal Ocular Irritation Evaluation

A. Initial test

No corneal, iridial or conjunctivae redness effects were noted during the observation period. THe testing animal was noted minimal conjunctival swelling in test substance treated eye at one hour after treatment. The conjunctival chemosis was observed normal at 24, 48 and 72 hours after treatment.

B. Confirmatory test

No corneal, iridial or conjunctivae redness effects were noted in the two additional testing animals during the observation period. The testing animals were noted minimal conjunctival swelling in test substance treated eye at one hour after treatment. The conjunctival chemosis was observed normal at 24, 48 and 72 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the conditions and results of the study, test substance administered to NZW rabbits by ocular instillation only caused minimal conjunctival swelling at one hour after instillation. The reversibility was noted at 24 hours after instillation. No corneal, iridial or conjunctivae redness effects were observed during the observation period. No corrosive or severe irritant effects were observed during the study. All data generated from this study will provide as safety reference for human exposure.