Registration Dossier
Registration Dossier
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EC number: 251-529-0 | CAS number: 33456-68-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-[2-(3,4-dihydro-7-methoxy-4,4-dimethyl-1,3-dioxo-2(1H)-isoquinolyl)ethyl]benzenesulphonamide
- EC Number:
- 251-529-0
- EC Name:
- p-[2-(3,4-dihydro-7-methoxy-4,4-dimethyl-1,3-dioxo-2(1H)-isoquinolyl)ethyl]benzenesulphonamide
- Cas Number:
- 33456-68-7
- Molecular formula:
- C20H22N2O5S
- IUPAC Name:
- 4-[2-(7-methoxy-4,4-dimethyl-1,3-dioxo-1,2,3,4-tetrahydroisoquinolin-2-yl)ethyl]benzene-1-sulfonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): AR-FD 26 ( phase X )
- Physical state: powder
- Lot/batch No.: 01010
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Diet (e.g. ad libitum): Conventional feeding
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 : 12
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/0.1g
A single dose of 0,1 g of was instilled onto the everted lower lid ( conjunctiva
sac) of one eye of each animal - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all animals
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- other: 1 h and 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- other: 48 h and 72 h
- Score:
- 0
- Irritation parameter:
- other: Iris Inflammation
- Basis:
- animal: all animals
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- other: Iris infalmmation
- Basis:
- animal: all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Conclusion: According to the supplement of the Official Billefing of Spain BOE
num. 133 ( Monday, June fifth 1995), the assayed product is classified as:
Not important eyes lesion cause
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