Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-544-3 | CAS number: 68123-13-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: No data available
- 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 mentioned below
- Principles of method if other than guideline:
- Micronucleus bone marrow cells assay were conducted to assess the mutagenic potential of basic blue 99 in mice.
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
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: Solid- Purity According 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
- Species:
- mouse
- Strain:
- other: CFW1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animals and env conditionsTEST ANIMALS- Source: - Age at study initiation: No data available- Weight at study initiation: 21-33 g- Assigned to test groups randomly: [no/yes, under following basis: ] 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 available ENVIRONMENTAL 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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicles- Vehicle(s)/solvent(s) used: NaCl- Justification for choice of solvent/vehicle: No data available- Concentration of test material in vehicle: No data available- Amount of vehicle (if gavage or dermal): No data available- Type and concentration of dispersant aid (if powder): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Details on exposure:
- Details on exposureFor oral routePREPARATION OF DOSING SOLUTIONS: Basic Blue 99 was prepared as in aqueous 0.9% NaCl solutionDIET PREPARATION- Rate of preparation of diet (frequency): No data available- Mixing appropriate amounts with (Type of food): No data available- Storage temperature of food: No data available
- Duration of treatment / exposure:
- Not specified
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48 and 72hr
Doses / concentrations
- Remarks:
- Doses / Concentrations:1500 mg/kgBasis:no data
- No. of animals per sex per dose:
- 6/sex/dose
- Positive control(s):
- Positive controlsEndoxan - Justification for choice of positive control(s): No data available- Route of administration: No data available- Doses / concentrations: No data available
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- No data available
- Evaluation criteria:
- Determination of micronucleus rate
- Statistics:
- No data available
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeBasic Blue 99 is non mutagenic in the micronucleus assay in bone marrow cells in male and female CFW mice.
- Executive summary:
Micronucleus bone marrow cells assay were conducted to assess the mutagenic potential of basic blue 99 in mice.
Basic Blue 99 (in aqueous 0.9% NaCl solution) was administered by gavage to 12 mice (6 mice per sex per test group) at a dose of 1500 mg/kg body weight. Endoxan was the positive control and the vehicle was the negative control. The incidence of micronucleated erythrocytes was evaluated at 24, 48, and 72 h by preparing bone marrow smears from both femurs from each animal.
There was no indication of mutagenic activity of Basic Blue 99 as determined by bone marrow examination of the remaining groups and no indication of a delayed cell proliferation.
Basic Blue 99 is non mutagenic in the micronucleus assay in bone marrow cells in male and female CFW mice.
According to the CLP classification, the test material is not a mutagen in vivo.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
