Registration Dossier
Registration Dossier
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EC number: 416-250-2 | CAS number: 84632-59-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-05-24- 1993-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on 24th Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 416-250-2
- EC Name:
- -
- Cas Number:
- 84632-59-7
- Molecular formula:
- C26 H28 N2 O2
- IUPAC Name:
- 3,6-bis(4-tert-butylphenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Age at study initiation: No data
- Weight at study initiation: 2400 - 2860 g
- Housing: Individually in metal cages.
- Diet: standard rabbit pellet – Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: No data
- Photoperiod: 12 hours light cycle day
IN-LIFE DATES: From: 1993-05-25 To: 1993-06-04
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (22 mg) / rabbit - Duration of treatment / exposure:
- Single treatment. The treated eyes were not rinsed after instillation.
- Observation period (in vivo):
- 72 hours (assessment of eye reactions at 1, 24, 48 and 72 hour(s))
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TEST ITEM PREPARATION / TEST SITE
- 0.1 mL (22 mg) of the test item was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test item.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes were not rinsed after instillation.
SCORING SYSTEM: numerical scoring system according to the OECD guideline 405
TOOL USED TO ASSESS SCORE: slit-lamp
OBSERVATIONS
- Viability/Mortality: Daily
- Clinical signs: Daily
- Body weights: recorded at start and on day 3
- Necropsy: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.22
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The eye reactions observed were reversible within 48 hours. Slight chemosis was noted in 1 rabbit at the 1-hour observation only. Two rabbits displayed slight conjunctival redness after 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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