Registration Dossier
Registration Dossier
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EC number: 204-155-7 | CAS number: 116-75-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP compliant OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- 1,4-bis(mesitylamino)anthraquinone
- EC Number:
- 204-155-7
- EC Name:
- 1,4-bis(mesitylamino)anthraquinone
- Cas Number:
- 116-75-6
- Molecular formula:
- C32H30N2O2
- IUPAC Name:
- 1,4-bis(mesitylamino)anthraquinone
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.28 - 2.81 kg
- Housing: individually housed in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers, Limited, New Leake, Boston, Lincolnshire, U.K. (ad libitum):
- Water: Drinking Water (ad libitum):
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 65 - 67
- Air changes (per hr): approximately 15
- Photoperiod: 12 hrs dark /12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Amount / concentration applied:
- 0.1 ml of the test material, weighing approximately 64 mg
- Duration of treatment / exposure:
- single application without removal by washing
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- SCORING SYSTEM:
CONJUNCTIVAE Redness: 0 - 3; Chemosis: 0 - 4; Discharge: 0 - 3
IRIS: 0 - 2;
CORNEA Degree of Opacity: 0 - 4; Area of cornea involved: 0 - 4
- TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1-3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: no signs of irritation at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 1-3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility: initial signs of slight irritation - if any - were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: # 1-3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility: initial signs of slight irritation - if any - were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: # 1-3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: initial signs of slight irritation - if any - were fully reversible within 24 h
- Irritant / corrosive response data:
- No adverse corneal effects were noted during the study.
Iridial inflammation was noted in two treated eyes one hour after treatment.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
All treated eyes appeared normal at the 24-hour observation. - Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test result, it is concluded that the test substance is not irritating to eyes.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 84/449/EEC.
A single application of the test material to the non-irrigated eye of three rabbits produced slight iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal 24 hours after treatment.
Based on these findings it is concluded that the test item is not irritating to eyes.
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