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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: no pathologic examination performed, no individual animal data, lack of details on test substance
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-nitrobenzene
EC Number:
202-809-6
EC Name:
1-chloro-4-nitrobenzene
Cas Number:
100-00-5
Molecular formula:
C6H4ClNO2
IUPAC Name:
1-chloro-4-nitrobenzene
Details on test material:
- Name of test material (as cited in study report): p-Nitrochlorbenzol
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Germany
- Weight at study initiation: 160 - 180 g
- Housing: 5 in one cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
no data
Doses:
100, 200, 300, 350, 400, 500, 600 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Statistics:
LD50 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:
294 mg/kg bw
Mortality:
200 mg/kg bw: 3/10 animals died 2d after application
300 mg/kg bw: 5/10 animals died 2-3d after application
350 mg/kg bw: 5/10 animals died 2-3d after application
400 mg/kg bw: 8/10 animals died 2-4d after application
500 mg/kg bw: 8/10 animals died 2-3d after application
600 mg/kg bw: 10/10 animals died 3h-4d after application
Clinical signs:
reduced general condition, cyanotic appearance, diarrhea, increased excretion of urine
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

Table 1:

Dose (mg/kg bw)

Time of death

Dead

Symptoms

Number of rats used

100

200

300

350

400

500

600

-

2d

2-3d

2-3d

2-4d

2-3d

3h-4d

0

3

5

5

8

8

10

0

10

10

10

10

10

10

10

10

10

10

10

10

10

Value: (232 - 349 mg/kg bw)


Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Classification:
GHS: Acute Oral Category 3
Executive summary:

Loeser (Bayer AG), 1979

The acute oral toxicity of 1 -chloro-4 -nitrobenzene was investigated in male Wistar II rats comparable to OECD guideline 401.

7 male groups of 10 animals were dosed with 100, 200, 300, 350, 400, 500 and 600 mg/kg bw 1-chloro-4 -nitrobenzene per gavage and observed for 14 days following exposure for mortality and clinical signs. Mortalities occurred at dose levels equal to and exceeding 200 mg/kg bw 2 days after administration. Reduced general condition, cyanotic appearance, diarrhea, increased excretion of urine were observed in all male animals dosed 200 - 600 mg/kg bw. Symptoms started to appear between 3 hours (600 mg/kg bw) and 4 days (400 and 600 mg/kg bw) after administration. No clinical signs were observed in animals dosed with 100 mg/kg bw in male rats. The calculated LD50 for male rats was 294 mg/kg bw.