Registration Dossier
Registration Dossier
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EC number: 268-544-3 | CAS number: 68123-13-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Basic Blue 99
- Author:
- American College of Toxicology
- Year:
- 2 007
- Bibliographic source:
- International Journal of Toxicology, 26(Suppl. 2):51–63, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Eye irritation study was performed on New Zealand rabbits to evaluate the irritant nature of the test compound Basic Blue 99
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- EC Number:
- 268-544-3
- EC Name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- Cas Number:
- 68123-13-7
- Molecular formula:
- C19H20BrN4O2.Cl
- IUPAC Name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- Reference substance name:
- Basic Blue 99
- IUPAC Name:
- Basic Blue 99
- Details on test material:
- - Name of test material (as cited in study report):Basic Blue 99- Molecular formula (if other than submission substance):C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance):451.75 g/mol- Substance type:Organic- Physical state:SolidPurityAccording to the Keystone Aniline Corporation (1999) the chemical is atleast 63% pure Another supplier of Basic Blue 99 (Henkel 1992) has a specification of 60.7% dye content- Impurities (identity and concentrations):According to the Keystone Aniline Corporation (1999) have no more than 100 ppm of ironAnother supplier of Basic Blue 99 (Henkel 1992) suggests the presence of 25.7% sugar content, 11.8% inorganic salts, and 1.8 % volatile matter/water crystallization.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animalTEST ANIMALS- Source:- Age at study initiation: No data available- Weight at study initiation: No data available- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Test system
- Vehicle:
- other: Saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5% Basic Blue 99 (0.1 ml)
- Duration of treatment / exposure:
- No data available
- Observation period (in vivo):
- 30 and 60 min and 1 and 2 days post instillation
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- TEST SITE- Area of exposure: The conjunctional sac of the left eye- % coverage: No data available- Type of wrap if used: No data availableREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableSCORING SYSTEM: Corneal and iris parameters were observed.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 30min and 60min and 1 and 2 days post instillation
- Reversibility:
- not specified
- Remarks on result:
- other: The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material Basic Blue 99 is non irritating to the eyes of rabbits.
- Executive summary:
Eye irritation study was performed on New Zealand rabbits to evaluate the irritant nature of the test compound Basic Blue 99
A solution of 0.5% Basic Blue 99 (0.1 ml) was instilled into the conjunctinal sac of the left eye and the right eye received 0.1 ml of vehicle alone (saline). Eye irritation was read at 30 and 60 min and 1 and 2 days post instillation. The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal. The study concluded that the mucous membrane injury threshold concentration for the rabbit eye is greater than 0.5% Basic Blue 99.
According to the publication, the test material Basic Blue 99 does not classify as an eye irritant.
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