Registration Dossier
Registration Dossier
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EC number: 221-717-7 | CAS number: 3209-22-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Acute oral toxicity in rats
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- 1,2-dichloro-3-nitrobenzene
- EC Number:
- 221-717-7
- EC Name:
- 1,2-dichloro-3-nitrobenzene
- Cas Number:
- 3209-22-1
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 1,2-dichloro-3-nitrobenzene
- Details on test material:
- - Analytical purity: No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 177 g
- Housing: 5 animals per cage (Macrolon Type III)
- Diet (e.g. ad libitum): Altromin R 1324 (Altromin GmbH, Lage, Germany) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg bw - Doses:
- 100, 500, 1000, 1500, 2000, 3100 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Animals were observed 1, 2, 4, 8 and 24 h post-application, and twice daily thereafter up to 14 days. Animals were weighed on the application day and at the end of the observation period (day 14). - Statistics:
- LD50 with confidence interval for p<= 0.05 was calculated by Probit-analysis (Fink and Hund 1965. Arzneim.-Forsch. 15:624).
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 070 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 0.77 - 1.36
- Remarks on result:
- other: clinical signs: reduced body weights, increased diuresis, sedation, scrubby coat
- Mortality:
- refer to remarks on results
- Clinical signs:
- other: refer to remarks on results
- Gross pathology:
- not examined
Any other information on results incl. tables
Mortality
Dose level (mg/kg bw) | Mortality |
100 | 0/10 |
500 | 1/10 |
1000 | 4/10 |
1500 | 8/10 |
2000 | 8/10 |
3100 | 10/10 |
Mortalities occurred at dose levels equal to and exceeding 500 mg/kg bw between day 2 and 9 following administration. Enhanced diuresis, loss of weight and scubby fur were observed in all animals dosed 500 - 3100 mg/kg bw. These symptoms were slight to moderate and started to appear 1 h (1000 - 3100 mg/kg bw) and on day 2 (500 mg/kg bw) after administration, continuing up to the end of the observation period. No clinical signs were observed in animals dosed with 100 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The calculated LD50 was 1070 mg/kg bw.
- Executive summary:
Löser (1980) The acute oral toxicity of 1,2 -dichloro-3 -nitrobenzene was investigated in male Wistar rats. 6 Groups of 10 animals were dosed with 100, 500, 1000, 1500, 2000 and 3100 mg/kg bw 1,2 -dichloro-3 -nitrobenzene per gavage, and observed for 14 days following the exposure for mortality and clinical signs. Mortalities occurred at dose levels equal to and exceeding 500 mg/kg bw between day 2 and 9 following administration. Enhanced diuresis, loss of weight and scubby fur were observed in all animals dosed 500 - 3100 mg/kg bw. These symptoms were slight to moderate and started to appear 1 h (1000 - 3100 mg/kg bw) and on day 2 (500 mg/kg bw) after administration, continuing up to the end of the observation period. No clinical signs were observed in animals dosed with 100 mg/kg bw. The calculated LD50 was 1070 mg/kg bw, with a confidence interval for p < 0.05 = 0.77 - 1.36
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