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EC number: 268-544-3 | CAS number: 68123-13-7
Endpoint summary
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
- 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.
Reference
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
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