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EC number: 276-677-3 | CAS number: 72479-30-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 14, 1981 to September 7, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Acid Brown 098
- IUPAC Name:
- Acid Brown 098
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100 - 180 g
- Fasting period before study: 18 hours after and 4 hours before administration of test item
- Diet: UAR D-04, ad libitum
- Water: deionised water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1 °C
- Humidity (%): 65 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark/light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: suspension 1% with CMC and 2% with water
- Amount of vehicle (if gavage): 40 ml/kg - Doses:
- 4000, 8000, 16000 mg/kg
- No. of animals per sex per dose:
- 5 per sex per doses
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 16 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 800 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 4 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- For concentrations above 4000 mg/kg
- Clinical signs:
- No signs of toxicity
- Gross pathology:
- At highest dose one of the surviving rats presents the kidneys of pale colour
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- The substance shows a LD50 =16000 mg/kg b.w.
- Executive summary:
The substance has been tested for acute toxicity by oral route according to a method similar to the one described by OECD Guideline 401; 30 Wistar rats are tested with the substance at concentration of 4000, 8000 and 16000 mg/kg by gavage, 10 animals per dose.
During the study the following rates of mortality were observed:
At the dose of 4000 mg/kg no mortality was observed and at the dose of 8000 mg/kg bw one rat were found dead. At the highest dose tested 5 rats died.
Results
LD50 = 16000 mg/kg bw
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