Registration Dossier
Registration Dossier
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EC number: 429-790-9 | CAS number: 137281-39-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 to 13 November 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoic acid
- EC Number:
- 429-790-9
- EC Name:
- 4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoic acid
- Cas Number:
- 137281-39-1
- Molecular formula:
- Hill formula: C15 H14 N4 O3 CAS formula: C15 H14 N4 O3
- IUPAC Name:
- 4-(2-{2-amino-4-oxo-3H,4H,7H-pyrrolo[2,3-d]pyrimidin-5-yl}ethyl)benzoic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Compound 202723
- Storage condition of test material: In the dark at ambient temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Outside vendor
- Weight at study initiation: 2.63-2.73 kg
- Housing: Stainless steel cages (dimensions approximately 77 x 70 x 50 cm)
- Diet: ad libitum supply of 'Teklad Diet' animal feed
- Water: ad libitum supply of domestic mains quality water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 -19°C
- Humidity: 55%
- Air changes (per hr): 15
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: The left eye remained untreated to act as a control
- Amount / concentration applied:
- TEST MATERIAL
Animals were treated with the weight equivalent of 0.1ml of the test material. Actual amount instilled (
weight equivalent of 0.1 ml) 52.2-52.7mg - Duration of treatment / exposure:
- Test material was placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were gently held together for 1 -2 seconds. The left eye remained untreated to serve as a control.
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE Information on the method used to remove test material from the eye post exposure is not documented in the test report.
SCORING SYSTEM: (Table 1 GRADING OF OCULAR LESIONS from OECD Guideline 405) TOOL USED TO ASSESS SCORE: hand held magnifier and pen torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- mean score animal 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No reaction
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Mean score animal 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reaction
- Remarks on result:
- other: Max value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean score animal 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reaction
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean score 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reaction
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Not classified as an eye irritant.
- Executive summary:
The acute eye irritation potential of compound 202723, was investigated in three New Zealand White rabbits.
One group of three male rabbits was treated with the weight equivalent of 0.1ml of the test material, instilled as supplied, into the conjunctival sac of one eye. The treated eye was then examined for evidence of irritation 1, 24 ,48 and 72 hours after instillation of the test material.
There were no reactions noted in any of the animals during the observation period.
Under the conditions of the study, compound 202723 is considered to be non-irritating to rabbit eyes.
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