Registration Dossier
Registration Dossier
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EC number: 606-440-5 | CAS number: 201214-53-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The test method was also in accordance with the Guidelines published in the Europenan 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 available
- Lot/batch No.: 204 386
- Expiration date of the lot/batch: 15/05/2001
- Stability under test conditions: no data
- Storage condition of test material: no data
- A certificate of analysis is included in the report.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- other: New zealand hybrid, SPF
- Details on test animals or test system 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- other: contralateral zone
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/animal - Duration of treatment / exposure:
- 4 hours on D1
- Observation period:
- 1h, 24h, 48h, 72h
- Number of animals:
- 3 animals/group
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
Cutaneous irritation
1) Erythema:
- < 2: Non-irritant
- >= 2: R38 (irritating to the skin)
2) Edema:
- < 2: Non-irritant
- >= 2: R38 (irritating to the skin)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean score of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean score of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean score of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean score of 24, 48 anf 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean score of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean score of 24, 48 and 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:
- Iodomesac was non irritant to the skin. It does not require labeling with any risk phrase.
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