Registration Dossier
Registration Dossier
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EC number: 291-103-1 | CAS number: 90341-71-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 05,1983 to July 08,1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance with enternational guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium
- EC Number:
- 291-103-1
- EC Name:
- Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium
- Cas Number:
- 90341-71-2
- Molecular formula:
- C22H14CuN4Na4O15S4
- IUPAC Name:
- Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Remazol Brillantblau BB
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG,
- Age at study initiation:
- Weight at study initiation: 2,8 - 3,6 kg
- Housing: in a climatizen room , inside a standard cage
- Diet : Altromin 2013 Zuchtdiat , ad libitum
- Water : deionized water with chloride , ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12 hrs cycle dark/light
Test system
- Vehicle:
- physiological saline
- Remarks:
- to form a paste
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
100 g
VEHICLE
0.01 mL physiol. saline - Duration of treatment / exposure:
- 24 Hrs
- Observation period (in vivo):
- 72 Hrs
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : yes, with warm physiol. saline
- Time after start of exposure: 24hrs
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: UV-lght, fluorescein (0.01%) and slit-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The conjunctiva at 1 h was blue discolored.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance did not show any evidence of irritation
- Executive summary:
The substance Remazol Brillant Blau BB has been tested on rabbit eye in experimental condition described on OECD guidelines. The test substance did not cause irritation in rabbit eyes.
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