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Toxicological information

Acute Toxicity: oral

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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: Study well documented, meets generally accepted scientific priciples, only male rats were used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Principles of method if other than guideline:
Single oral application of different doses to male Wistar rats and observation for mortality and signs of toxicity for 14 days.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 1,2-dichloro-4-nitrobenzene, no data on purity

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 91-121 g (mean: 103 g
- Fasting period before study: yes, 16 hours
- Diet ad libitum 2 hours post dosing
- Water ad libitum 2 hours post dosing


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4%
Doses:
250, 400, 630, 1000 or 1250 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: daily observations and weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
625 mg/kg bw
95% CL:
>= 526 - <= 744
Mortality:
250 mg: 0/10 rats;
400 mg: 1/10 rats;
630 mg: 5/10 rats;
1000 mg: 9/10 rats;
1250 mg: 10/10 rats Deaths occurred within 1-3 days after application.
Clinical signs:
moribund animals showed disorders of balance, reduced general condition and died
in prone positition.
Body weight:
in surviving rats body weight development of the test animals was comparable to control animals
Gross pathology:
section of animals that had died during the study and of animals that survived were without macroscopical findings.
Other findings:
no further details

Any other information on results incl. tables

RS-Freetext:
Mortality:
250 mg: 0/10 rats; 400 mg: 1/10 rats; 630 mg: 5/10 rats; 1000 mg: 9/10 rats; 1250 mg: 10/10 rats
Deaths occurred within 1-3 days after application.
Signs of intoxication:
moribund animals showed disorders of balance, reduced general condition and died in prone positition.
Gross pathological examination:
The macroscopic examination of surviving and dead animals gave no adverse effects.

Applicant's summary and conclusion

Executive summary:

Single oral application of 1,2 -dichloro-4 -nitrobenzene to male rats and observation of 14 days resulted in LD50 of 625 mg/kg bw. Signs of intoxication were disorder in balance, reduced general condition and death in prone position.(Hoechst AG 1975)