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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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Chlor-1-nitrobenzol
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Winkelmann, Borchen, Germany
-Weight: 160-230g
-Housing: single per cage (Macrolon Type III)
-Diet: Altromin-Standarddiät, Altromin GmbH, Lage/Lippe, Germany

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
no data
Doses:
male: 50, 100, 150, 200, 250, 300, 500 mg/kg bw
female: 25, 50, 100, 250, 350, 500, 650, 850 mg/kg bw
No. of animals per sex per dose:
15
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Statistics:
LD50 was calculated by Probit-analysis (Fink and Hund 1965. Arzneim.-Forsch. 15:624), Litchfield and Wilcoxon (J. Pharmacol. Exp. Therap. 96, 99, 1949)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
219 mg/kg bw
95% CL:
196 - 243
Sex:
female
Dose descriptor:
LD50
Effect level:
457 mg/kg bw
95% CL:
398 - 518
Mortality:
Male rats:
150 mg/kg bw: 2/15 animals died 2d after application
200 mg/kg bw: 4/15 animals died 24h after application
250 mg/kg bw: 10/15 animals died between 1-2d after application
300 mg/kg bw: 14/15 animals died 24h after application
500 mg/kg bw: 15/15 animals died 24h after application

Female rats:
250 mg/kg bw: 1/15 animal died 8d after application
350 mg/kg bw: 2/15 animals died between 1-2d after application
500 mg/kg bw: 10/15 animals died between 1-2d after application
650 mg/kg bw: 12/15 animals died between 1-2d after application
850 mg/kg bw: 15/15 animals died between 1-2d after application
Clinical signs:
Reduced general condition and cyanotic appearance were observed in all male animals dosed 100 - 500 mg/kg bw and in all female rats dosed with 50 - 850 mg/kg bw
Body weight:
not examined
Gross pathology:
not examined

Any other information on results incl. tables

Acute oral toxicity

Dose (mg/kg)

Conc. %

Result

Signs of intoxication

Time of death

m/s/n

Start

End

 

Male rats

50

100

150

200

250

300

500

1

2

3

4

5

6

10

0/0/15

0/15/15

2/15/15

4/15/15

10/15/15

14/15/15

15/15/15

-

49min

20min

16min

36min

13min

18min

-

5d

7d

7d

11d

9d

-

-

-

2d

24h

1-2d

24h

24h

Female rats

25

50

100

250

350

500

650

850

0.5

1

2

5

7

10

13

17

0/0/15

0/15/15

0/15/15

1/15/15

2/15/15

10/15/15

12/15/15

15/15/15

-

24h

24h

90min

11min

2h

8min

2h

-

3d

7d

7d

7d

13d

12d

-

-

-

-

8d

1-2d

1-2d

1-2d

1-2d

m: number of rats which died

n: number of animals put in test

s: number of animals with signs of intoxication: reduced general condition, cyanotic appearance

Applicant's summary and conclusion

Conclusions:
DSD: Xn, R22 Harmful if swallowed
GHS: Acute Oral Category 3
Executive summary:

Gröning P (Bayer AG), 1976

The acute oral toxicity of 1 -chloro-2 -nitrobenzene was investigated in male and female Wistar II rats. 7 male and 8 female groups of 15 animals were dosed with 50, 100, 150, 200, 250, 300 and 500 mg/kg bw and 25, 50, 100, 250, 350, 500, 650 and 850 mg/kg bw 1 -chloro-2 -nitrobenzene per gavage and observed for 14 days following exposure for mortality and clinical signs.

Mortalities occurred at dose levels equal to and exceeding 150 mg/kg bw between 24 hours and 2 days after administration in male rats and in female rats at dose levels equal to and exceeding 250 mg/kg bw between 24 hours and 8 days. Reduced general condition and cyanotic appearance were observed in all male animals dosed 100 - 500 mg/kg bw and in all female rats dosed with 50 - 850 mg/kg bw. Symptoms started to appear 8 min (650 mg/kg bw, females) and 24 hours (50 and100 mg/kg bw, females) after administration, continuing up to 13 days. No clinical signs were observed in animals dosed with 25 mg/kg bw in females and 50 mg/kg bw in male rats. The calculated LD50 for male rats was 219 mg/kg bw and 457 mg/kg bw for female rats.