Registration Dossier

Diss Factsheets

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:
2007
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

Constituent 1
Chemical structure
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-1-hydroxy-8-imino-5-oxo-5,8-dihydronaphthalen-2-yl)amino]-N,N,N-trimethylanilinium chloride
Constituent 2
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.

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.