Registration Dossier
Registration Dossier
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EC number: 413-210-6 | CAS number: 192662-33-2 ORASOL ROT 1988C
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP and OECD testing guideline similar study with well characterized test material. Only one animal uesed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal tested
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
- EC Number:
- 413-210-6
- EC Name:
- tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
- Cas Number:
- 192662-33-2
- Molecular formula:
- UVCB substance
- IUPAC Name:
- chromium(3+) 2-methyltridecan-2-aminium bis(4-{2-[5-(2,2-dimethylpropyl)-3-nitro-2-oxidophenyl]diazen-1-yl}-3-methyl-1-(3-sulfamoylphenyl)-1H-pyrazol-5-olate)
- Details on test material:
- - Substance type: pigment, powder
- Physical state: solid
- Analytical purity: 96.1%
- Purity test date: no data
- Lot/batch No.: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997
- Stability under test conditions: yes
- Storage condition of test material: room 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: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: no data
- Weight at study initiation: 2850 g
- Housing: individually
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-02-11 To: 1993-03-03
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml (70 mg)
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cornea, iris and chemosis
- Basis:
- animal #1
- Time point:
- other: 1h - 7days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1, 24 and 48h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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