Registration Dossier
Registration Dossier
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EC number: 202-716-0 | CAS number: 98-95-3
Acute Toxicity: oral
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: Meets generally accepted scientific standards, documentation restricted and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- 10 male Wistar rats/group; 0.3, 0.4, 0.5, 0.6 and 0.7 ml/kg; p.a. observation period 14 days
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Nitrobenzene
- EC Number:
- 202-716-0
- EC Name:
- Nitrobenzene
- Cas Number:
- 98-95-3
- Molecular formula:
- C6H5NO2
- IUPAC Name:
- nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): nitrobenzene
- Analytical purity: 99.9%
- Impurities (identity and concentrations): dinitrobenzene (< 0.07%), benzen (< 0.01%), water (< 0.01%), nitrophenole (< 3ppm), sulfur (> 1 ppm), hydrocarbons (> 10 ppm), nitrotoluene ( > 20 ppm)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 0.3, 0.4, 0.5, 0.6 and 0.7 mL/kg (equivalent to 360, 480, 600, 720 and 840 mg/kg bw)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Statistics:
- Chi-square test with 95% confidence limits.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 588 mg/kg bw
- 95% CL:
- 480 - 648
Any other information on results incl. tables
A dose of 360 mg/kg did not cause mortalities, but all of the animals demonstrated clinical signs. These clinical signs included cyanosis (all dose groups), perturbance of equilibrium, piloerection, sedation 600 – 840 mg/kg bw), bloody eyes and poor reflexes. In animals receiving up to 480 mg/kg bw, clinical signs occurred 1 h after administration whereas in all other dose groups they occurred alreade after 15 min. 2/10 rats died after administration of 480 mg/kg, 5/10 rats after 600 mg/kg, 8/10 rats after 720 mg/kg and all 10 rats after 840 mg/kg. Mortalities occurred on days 2 to 4. Information on necropsy is not given.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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