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Description of key information

oral


Single oral application of 1,2 -dichloro-4 -nitrobenzene to male rats 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). 


inhalation
There are no valid acute inhalation studies available.


dermal
Single dermal application of 1,2 -Dichloronitrobenzene to the shaved, intact back of 6 female rats caused no mortality and no clinical findings. Thus the LD50 > 2000 mg/kg bw is determined (Hoechst AG 1975).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific priciples, only male rats were used
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
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system 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
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4%
Doses:
250, 400, 630, 1000 and 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
Sex:
male
Dose descriptor:
LD50
Effect level:
625 mg/kg bw
Based on:
test mat.
95% CL:
>= 526 - <= 744
Mortality:
The following deaths occurred within 1-3 days after application:
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
Clinical signs:
other: moribund animals showed disorders of balance, reduced general condition and died in prone positition.
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
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
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.
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).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
695 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific priciples, only female rats were used
Principles of method if other than guideline:
TS (40 % solution) was applied on the clipped skin of the back under occlusive conditions over 24 hrs, then the skin was washed,
post application observation period: 14 d
feed and water ad libitum
observation for signs of intoxication
rats were weighed daily (excluding weekend)
after termination of the observation time: rats were necropsied and gross pathologically examined
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMAL
- Weight at study initiation: 167-193 g
- Housing: individually
- Diet . ad libitum
- Water: ad libitum
Type of coverage:
occlusive
Vehicle:
other: sesame oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm²
- Type of wrap if used: alu foil

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological examination
Statistics:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed: 0/6
Clinical signs:
other:
Gross pathology:
The macroscopic examination after 14 d showed no adverse effects.
Interpretation of results:
GHS criteria not met
Conclusions:
An LD50 > 2000 mg/kg bw is determined.
Executive summary:

Single dermal application of 1,2 -Dichloro-4-nitrobenzene at a dose of 2000 mg/kg bw/d to the shaved, intact back of 6 female rats caused no mortality and no clinical findings. Thus the LD50 > 2000 mg/kg bw is determined (Hoechst AG 1975).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

oral route:


Single oral application of 1,2 -dichloro-4 -nitrobenzene to male rats 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). Single oral application of undiluted,warmed up to 40 °C testsubstance (technical grade) to male and female rats yielded LD50 of 950 mg/kg bw. Signs of intoxication. weight loss, salivation, occular discharge and collaps (Monsanto 1978). Methemoglobinemia was shown in cats (Hoechst 1975).


inhalation route:


There are no valid acute inhalation studies available. 1,2 -Dichloro-4 -nitrobenzene shall be registrated according Regulation (EC) 1907/2008 (REACH) Article 18 (transported isolated intermediate) and no studies are required according REACH Annex VII.


dermal route:


Single dermal application of 1,2 -Dichloronitrobenzene to the shaved, intact back of 6 female rats caused no mortality and no clinical findings. Thus the LD50 > 2000 mg/kg bw is determined (Hoechst AG 1975).

Justification for classification or non-classification

Based on the existing acute and repeated dose studies the substance might be harmful due to formation of methaemoglobin. As humans are regarded as potentially more sensitive to this effect, a more strict classification as indicated by the study data is applied (increas by one hazard category). As cutaneous and inhalative absorption is also possible based on the physico-chemical data, a classification is also done for these two routes. This leads the following classification: Acute tox 3 – oral (H301), Acute Tox 4 – dermal (H312), Acute Tox 3 – inhalation (H331).