Registration Dossier
Registration Dossier
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EC number: 230-426-4 | CAS number: 7128-64-5
Eye irritation
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:
- 1 975
- 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
- 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
Constituent 1
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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