Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
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
Species:
mouse
Strain:
CF-1
Sex:
male
Details on test animals or test system 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
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
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:
other: Decreased activity, increased breathing and tremors were observed at 1580 mg/kg bw
Gross pathology:
No data available
Other findings:
No data available
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 700 mg/kg bw
Quality of whole database:
Available data is of Klimisch rating 2 and of good quality with all required information

Additional information

In a study conducted by American College of Toxicology (2007), acute oral toxicity were evaluated in CF1 male mice by using Basic Blue 99 in the concentration of between 1.58-5.01 mg/kg administered by gavage. 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. Therefore, LD50 for the test chemical Basic Blue 99 is found to be between 2700 mg/kg.

Similar to above reference, acute oral toxicity were evaluated in 10 Sprague-Dawley male and female rats by using Basic Blue 99 in the concentration of single oral dose of 2.0 g/kg body weight Basic Blue 99 using a syringe and a plastic catheter. On the basis of observation made, Therefore, LD50 for the test chemical Basic Blue 99 is found to be >2000 mg/kg.

According to the CLP classification, the test material Basic Blue 99 (CAS no 68123 -13 -7) does not classify as an acute oral toxicant.


Justification for selection of acute toxicity – oral endpoint
LD50 for the test chemical Basic Blue 99 is found to be between 2700 mg/kg.

Justification for classification or non-classification

The test material Basic Blue 99 (CAS no 68123-13-7) does not classify as an acute oral toxicant.according to CLP classification