Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
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:
other: as per mentioned below
Principles of method if other than guideline:
Acute oral toxicity study was performed on CFY rats to evaluate the toxic nature of the test compound Basic Blue 99
GLP compliance:
no
Test type:
other: No data available
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 theKeystone 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 theKeystone 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:
CF-1
Sex:
male
Details on test animals and environmental conditions:
Details on test animalTEST ANIMALS- Source:- Age at study initiation: No data available- Weight at study initiation: 20 to 22 g- 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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE- Concentration in vehicle: 1580- 5010 mg/Kg bw - Amount of vehicle (if gavage): No data available- Justification for choice of vehicle: No data available- Lot/batch no. (if required): No data available- Purity: No data availableMAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bwDOSAGE PREPARATION (if unusual): Basic Blue 99was applied once by gavage at six dosages between 1580- 5010 mg/Kg bw at a dosage volume of 20 ml/kg bw. CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: No data available
Doses:
1580 -5010 mg/kg
No. of animals per sex per dose:
10 males/ dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days - Frequency of observations and weighing: No data available- Necropsy of survivors performed: No data available - Other examinations performed: clinical signs, mortality
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 700 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Decreased activity, increased breathing and tremors
Mortality:
50% mortality (5/10)
Clinical signs:
Decreased activity, increased breathing and tremors were observed at 1580 mg/kg bw
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for the test chemical Basic Blue 99 is found to be between 2700 mg/kg.
Executive summary:
Acute oral toxicity study was performed on

10 male CF1 mice at six dose levels between1580 -5010 mg/kg bw at a dosage volume of 20 ml/kg body weight.

Animals were observed for 7 days. Immediately following Basic Blue 99 administration decreased activity, increased breathing, and tremors were noted at doses of 1580 mg/Kg and greater.

The acute oral LD50 for the test chemical Basic Blue 99 is found to be between 2700 mg/kg.

According to the CLP classification, the test material does not classify as an acute oral toxicant.