4-nitrotoluene

Acute Toxicity: oral

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: Basic data given (No OECD guideline or GLP defined; no necropsy and no histopathological examinations were performed)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No GLP study. Analytical purity not reported. Animals were not fasted before the treatment. Enviromental conditions not reported. Acclimation period not reported. Body weights not reported. No necropsy and no histopathological examinations were performed

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:

4-nitrotoluene

EC Number:

202-808-0

EC Name:

4-nitrotoluene

Cas Number:

99-99-0

Molecular formula:

C7H7NO2

IUPAC Name:

1-methyl-4-nitrobenzene

Details on test material:

- Name of test material (as cited in study report): 4-nitrotoluene
- Physical state: solid
- Analytical purity: not reported

Test animals

Species:

rat

Strain:

other: Wistar-II-R

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 160-245 g
- Housing: animals were housed in Makrolon cages, type 3
- Diet (e.g. ad libitum): Altromin-Standarddiät (Altromin GmbH, Lage/Lippe, Germany) ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Polyethylene glycol 400

Doses:

100, 250, 500, 1000, 2250 mg/kg bw

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
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 250 mg/kg bw

Mortality:

see "Remarks on results tables and figures"

Clinical signs:

other: other: Symptoms of poisoning began in rat from 4 to 40 minutes after application in the form of disordered breathing and a reduced general condition. The respiratory disturbances were observed until 3 days after application, and the general condition was

Any other information on results incl. tables

		Symptoms of poisoning		Appereance ofdeath
Dosis mg/kg	Toxicological results	Start	End
Male rats
100	0/0/15	-	-	-
250	0/15/15	29´	2d	-
500	0/15/15	21´	4d	-
1000	0/15/15	18´	4d	-
2250	0/15/15	4´	6d	-
Female rats
100	0/0/15	-	-	-
250	0/15/15	40´	3d	-
500	0/15/15	35´	4d	-
1000	0/15/15	20´	5d	-
2250	0/15/15	12´	5d	-

 

In this table in the column "Toxicological results" the numbers have the following meaning:

1^stnumber= amount of dead animals

2^ndnumber = amount of animals with symptoms

3^rdnumber = amount of animals used

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study male rats received the test substance in a dose of 100, 250, 500, 1000 or 2250 mg/kg bw in Polyethylenglycol 400. Symptoms of poisoning began in rat from 4 to 40 minutes after application in the form of disordered breathing and a reduced general condition. The respiratory disturbances were observed until 3 days after application, and the general condition was to be reduced to 6 days. No mortalities were observed. Therefore the LD 50 was >2250 mg/kg bw (Bayer AG, 1976).