3-nitrotoluene

Acute Toxicity: oral

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Reference 2

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

Limit test:

no

Test material

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 121 mg/kg bw

95% CL:

1 924 - 2 338

Effect levels 2

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:

other: 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 oc

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	7´	6d	1-4d
2500	12/15/15	4´	6d	1-2d
3500	15/15/15	2´	-	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	9´	6d	1-3d
3500	15/15/15	5´	-	1-2d

 

Applicant's summary and conclusion

Executive summary:

Bayer AG: Gröning & Kimmerle (1976):

The acute oral toxicity of 3-nitrotoluene was investigated on male and female rats, in a pre-GLP study equivalent or similar to OECD 401. 

 

Clinical observations appeared 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. A decrease of the general conditions occured from 2 to 6 days after the application. Deaths occurred within 24 hours to 4 days after application. At necropsy, the liver of mortalities was mottled in appearance.

 

After observation period of 14 days the LD₅₀ was calculated as:

• 2121 mg/kg bw (95% CL:1924 -2338) in male rats


• 1784 (95% CL: 1616 -1982), in female rats.