1,2-dichloro-4-nitrobenzene

Endpoint summary

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).