Registration Dossier
Registration Dossier
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EC number: 271-176-6 | CAS number: 68516-73-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate
- EC Number:
- 271-176-6
- EC Name:
- Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate
- Cas Number:
- 68516-73-4
- Molecular formula:
- C34H32N6O12
- IUPAC Name:
- tetramethyl 2,2'-{1,4-phenylenebis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}diterephthalate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Yellow powder
Investing the test material with regard to its particle size is no longer possible (study performed 25 years ago). The data owner informed the lead registrant that the test material does not fulfill the criteria of a nanomaterial according to the EU definition.
No purity provided in study report.
Constituent 1
- Specific details on test material used for the study:
- - Expiration Date: May 18, 2021
- Lot # : 2757
- Stability under test conditions: stable for the duration of testing
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. (USA)
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 - 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: June 6-16, 2011
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mL (0.03 mg)
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein
Prior to instillation, 2-3 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmie Solution, 0.5%) were placed into both the treated and control eye of each animal. One-tenth of a milliliter (0.03 g) of the test substance was then instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There was no corneal opacity or iritis observed in any treated eye during the study. Within one hour after test substance instillation, all three treated eyes exhibited minimal conjunctivitis. All animals were free of ocular irritation by 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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