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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific pronciples, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
prior to GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)
EC Number:
230-426-4
EC Name:
2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)
Cas Number:
7128-64-5
Molecular formula:
C26H26N2O2S
IUPAC Name:
5-tert-butyl-2-[5-(5-tert-butyl-1,3-benzoxazol-2-yl)thiophen-2-yl]-1,3-benzoxazole

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 55 +/-5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

VEHICLE
- Amount applied: not applicable
Duration of treatment / exposure:
Once, the test substance was inserted into the conjunctival sac of the left eye each and the lids were gently held open for one second.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes (animal 1-3) / no (animal 4-6)
- Time after start of exposure: 30 sec

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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