Registration Dossier
Registration Dossier
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EC number: 606-440-5 | CAS number: 201214-53-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Protocol approval date: 21 September 2000 - Report approval date: 19 April 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study report did contain a reference to an international guideline but without detailed documentations. Further, the study was performed according to SOP in a laboratory that conforms to GLP, but the report was not audited by the QAU.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Also in accordance with the Guidelines published in the European Community Gazette (L383A, 29 December 1992).
- GLP compliance:
- no
- Remarks:
- Study performed according to SOP in a laboratory that conforms to GLP, but report not audited by the QAU
Test material
- Reference substance name:
- Iodomesac
- IUPAC Name:
- Iodomesac
- Reference substance name:
- Methyl 4-(acetylamino)-5-iodo-2-methoxybenzoate
- IUPAC Name:
- Methyl 4-(acetylamino)-5-iodo-2-methoxybenzoate
- Reference substance name:
- methyl 4-acetamido-5-iodo-2-methoxybenzoate
- EC Number:
- 606-440-5
- Cas Number:
- 201214-53-1
- Molecular formula:
- C11H12INO4
- IUPAC Name:
- methyl 4-acetamido-5-iodo-2-methoxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): Iodomesac
- Physical state: solid, powder
- Impurities (identity and concentrations): no data
- Lot/batch No.: 204 386
- Stability under test conditions: no data
- Storage condition of test material: no data
- Expiration date of the lot/batch: 15/05/2001
- A certificate of analysis is included in the report.
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New zealand hybrid, SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre LAGO, 01540 Vonnas, France
- Age at study initiation: 22 weeks
- Weight at study initiation: 4 kg ± 500 g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
Test system
- Vehicle:
- not specified
- Controls:
- other: the other eye used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): test substance as such at 100 mg/animal. - Duration of treatment / exposure:
- one administration in the conjunctival sac.
- Observation period (in vivo):
- D8 (1 hour after treatment), D9 (24h), D10 (48h), D11 (72h):
- Conjunctiva (chemosis, discharge, redness)
- Iris (aspect and reaction to light)
- Cornea (degree and area of opacity) - Number of animals or in vitro replicates:
- 3 males/group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no data
SCORING SYSTEM OCULAR IRRITATION:
Conjunctiva redness (A)
Conjunctiva edema (B)
Iris lesion (C)
Corneal opacity (D)
Non-irritant:
A < 2.5
B < 2
C < 1
D < 2
R36 (irritating to the eye):
A >= 2.5 or
B >= 2 or
1 =< C < 2 or
2 =< D < 3
R41 (risk of severe ocular lesion)
C = 2 or D >= 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean s core of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean score of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Non irritant to the eye
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