Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
1980
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3-Dichloronitrobenzene
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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
95% CL:
0.77 - 1.36
Mortality:
refer to remarks on results
Clinical signs:
refer to remarks on results
Body weight:
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:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
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