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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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 16 Code of Federal Regulation (CFR) 1500.42 (Formerly 21 CFR 191.12)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
EC Number:
204-279-1
EC Name:
2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
Cas Number:
118-82-1
Molecular formula:
C29H44O2
IUPAC Name:
2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
Details on test material:
- Name of test material (as cited in study report): Antioxidant 702 ND
- Substance type: Antioxidant
- Physical state: Fine yellow powder
- Analytical purity: No data
- Purity test date: No data
- Lot/batch No.: 1325-76 (date: 9-14-76)
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

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: 1.9 to 2.3 kg
- Housing: Rabbits were individually housed and equilibrated in the testing laboratory Bio/dynamics Inc.
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
Note: Only animals which were determined to be free of ocular defects prior to compound administration were used in this study.

ENVIRONMENTAL CONDITIONS : No data

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
The test material was instilled into one eye of each of the six rabbits using a 0.1 mL eye-cup .
Duration of treatment / exposure:
7 days
Observation period (in vivo):
The eyes were examined and scored for ocular reactions on Days 1, 2, 3, 4 and 7 following compound administration.
Number of animals or in vitro replicates:
Six rabbits - Test material was instilled into one eye of each of the 6 rabbits.
Details on study design:
SCORING SYSTEM: Similar to the score system presented in the OECD guideline 405 Acute eye irritation/corrosion
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0.055
Max. score:
1
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
other: 2, 3 & 4 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
other: 2, 3 & 4 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
6 animals
Time point:
other: 2, 3 & 4 days
Score:
0.055
Max. score:
1
Reversibility:
fully reversible
Remarks:
After 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
other: 2, 3 & 4 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
After 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the experiment, the substance 4,4 '-Methylenebis (2,6-di-tert-butylpehnol) is not considered as irritating to eyes.