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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: Acceptable, well documented publication/study report which meets basic scientific principles
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976
Reference Type:
review article or handbook
Title:
BUA-Stoffbericht Nr. 41: Nitrotoluole
Author:
BUA (Beratergremium umweltrelevanter Altstoffe) (BUA)
Year:
1989
Bibliographic source:
Gesellschaft Deutscher Chemiker (Hrsg Behret) Bd 41, VCH (Verlag Chemie), Weinheim 1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No GLP study. Analytical purity not reported. Enviromental conditions not reported. No fasting period before treatment. Acclimation period not reported. Body weights not reported
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
3-nitrotoluene
EC Number:
202-728-6
EC Name:
3-nitrotoluene
Cas Number:
99-08-1
Molecular formula:
C7H7NO2
IUPAC Name:
3-nitrotoluene
Details on test material:
- Name of test material (as cited in study report): 3-nitrotoluene
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 165-265 g
- Fasting period before study: no
- Housing: Makrolon cages type III
- Diet (e.g. ad libitum): Altromin Standard diet (Altromin GmbH, Lage/Lippe; Germany), ad libitum
- Water (e.g. ad libitum):ad libitum


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:


MAXIMUM DOSE VOLUME APPLIED:


DOSAGE PREPARATION (if unusual):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
250, 500, 1000, 1500, 2000, 2500, 3500 mg/kg
No. of animals per sex per dose:
15
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, grosspathology
Statistics:
LD50 was calculated with the Probit Analysis (Fink et al, Methods of information in medicine 5, 19, 1966)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 121 mg/kg bw
95% CL:
1 924 - 2 338
Sex:
female
Dose descriptor:
LD50
Effect level:
1 784 mg/kg bw
95% CL:
1 616 - 1 982
Mortality:
Mortality of the animals appeared within 24 hours after the treatment until 4 days
Clinical signs:
The poisoning symptoms appeared already between 2 and 35 minutes after dosing in form of sedation, cyanosis, reduction of general conditions.
Sedation and cyanosis were observed until 3 days after the application. The decrease of the general conditions occured from 2 to 6 days after the application
Body weight:
no data
Gross pathology:
Liver appeared spotted

Any other information on results incl. tables

 

 

Symptoms of poisoning

 

Appereance of death

Dosis mg/kg

Toxicologicalresults

Start

End

Male rats

250

0/0/15

-

-

-

500

0/15/15

25´

2d

-

1000

0/15/15

15´

4d

-

1500

1/15/15

13´

5d

2d

2000

5/15/15

6d

1-4d

2500

12/15/15

6d

1-2d

3500

15/15/15

-

1-2d

Female rats

250

0/0/15

-

-

-

500

0/15/15

35´

2d

-

1000

0/15/15

24´

4d

-

1250

1/15/15

14´

4d

3d

1500

5/15/15

10´

5d

2-4d

2000

10/15/15

10´

6d

1-2d

2500

13/15/15

6d

1-3d

3500

15/15/15

-

1-2d

 

Applicant's summary and conclusion

Executive summary:

Gröning (1976):

The acute oral toxicity of 3-nitrotoluene was investigated on male and female rats.

After observation period of 14 days the LD50 was calculated as 2121 mg/kg bw (95% CL:1924 -2338) in male rats and 1784 (95% CL: 1616 -1982), in female rats.

The poisoning symptoms appeared already between 2 and 35 minutes after dosing in form of sedation, cyanosis, reduction of general conditions. Sedation and cyanosis were observed until 3 days after the application. The decrease of the general conditions occured from 2 to 6 days after the application.