Registration Dossier
Registration Dossier
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EC number: 248-502-0 | CAS number: 27503-81-7
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- EC Number:
- 248-502-0
- EC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Cas Number:
- 27503-81-7
- Molecular formula:
- C13H10N2O3S
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: EMD SPF
- Weight at study initiation: 107 (100 - 120) g
- Housing: group of 2-3 animals in Macrolon Type III cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24- 28 °C
- Humidity (%): 30 - 40 %
IN-LIFE DATES: From: day 1 To: day 14
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Doses:
- 640, 800, 860, 1000, 1250, 1400, 1600 mg/kg
- No. of animals per sex per dose:
- 10 (5m; 5f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Probit analysis
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 046 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 961 - 1 139
- Remarks on result:
- other: after 14 days of observation
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 062 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 981 - 1 150
- Remarks on result:
- other: after 7 days observation
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 078 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 000 - 1 163
- Remarks on result:
- other: after 1 day observation
- Mortality:
- Dose Dead/Total Dead Male/Dead Female
mg/kg day 1 day 7 day 14
640 0/10 0/10 0/10 0/0
800 0/10 0/10 1/10 1/0
860 1/10 2/10 2/10 2/0
1000 4/10 4/10 4/10 0/4
1250 7/10 7/10 7/10 4/3
1400 10/10 5/5
1600 10/10 5/5 - Clinical signs:
- Immediately after injection the rats of all dose groups showed staggering, hypokinesia, spasmodic prone position, and deep, slow breathing, all of which lasted for several hours. 24 hours after commencement of the trial, the surviving rats still showed hypokinesia and deep, slow breathing. 2 to 3 days later they were again without abnormalities. The majority of the lethally intoxicated rats died in prone position with dyspnoea within 1 to 24 hours of the injection.
- Body weight:
- normal development
- Gross pathology:
- No changes were observed in the animals which could be attributed to the substance administered.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the LD50 value after ip injection in rats is at 1046 mg/kg bw after an observation period of 14 days.
- Executive summary:
Study Design
The acute toxicity of the test material was investigated in Wistar-AF rats after intraperitoneal injection. The test item was administered ip as an aqueous solution at dose levels of 640, 800, 860, 1000, 1250, 1400, 1600 mg/kg. Five male and five female animals were used per dose group.
Results
Immediately after injection the rats of all dose groups showed staggering, hypokinesia, spasmodic prone position, and deep, slow breathing, all of which lasted for several hours. 24 hours after commencement of the trial, the surviving rats still showed hypokinesia and deep, slow breathing. 2 to 3 days later they were again without abnormalities. The majority of the lethally intoxicated rats died in prone position with dyspnoea within 1 to 24 hours of the injection.
The body weight was inconspicous. The animals sacrificed and dissected after a 14 -day observation period, were macroscopically without abnormalities.
Conclusion
Based on the results of this study, the LD50 value after ip injection in rats is at 1046 mg/kg bw after an observation period of 14 days.
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