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

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Method: other: 5 rats/sex/dose group, 1 dose only as 30 % emulsion covered by aluminium foil fixed by broad stripes of adhesive plaster to back and belly for a 24 hour-exposure period: cleaning with soap and water, observation period: 1 week

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

Test type:

other: Acute dermal toxicity study in rats

Limit test:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4-Nitrotoluene
- Physical state: solid (yellow crystal)
- Analytical purity: no data

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Remarks:

polyethylene glycol 400

Duration of exposure:

24 h

Doses:

750 mg/kg bw in polyethylene glycol 400

No. of animals per sex per dose:

10

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 750 mg/kg bw

Remarks on result:

other: No mortality occurred.

Mortality:

No mortalities could be observed.

Clinical signs:

other: After 18 hours after application of the test substance a decrease of general behavior could be observed in the animals. This condition persisted 5 days.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

LD50 (dermal, rat, occlusive, 24h) >750 mg/kg bw.

Executive summary:

When applied as an emulsion in polyethylene glycol 400 at a dose level of 750 mg/kg bw to the back of 5 rats/sex/group, no deaths during the 24 hour treatment period and during the one week observation period were noted, but the rats showed poor general condition from 18 hours post application up to 4 days after application.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: inhalation

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

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

see "Any other information on material and method incl. tables"

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

Test type:

other: acute toxicity inhalation study, rats

Limit test:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4-Nitrotoluene
- Physical state: solid (yellow crystalline substance)
- Analytical purity: no data

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: air

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

1 h

Concentrations:

4167 mg/m³ air.

No. of animals per sex per dose:

5

Control animals:

not specified

Sex:

male

Dose descriptor:

LC50

Effect level:

> 4 167 mg/m³ air

Exp. duration:

1 h

Remarks on result:

other: No mortality occurred.

Mortality:

No martality occurred.

Clinical signs:

other: No signs of intoxication during the one hour exposure time or the 7 days post exposure observation period could be observed.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LC50 (rat, inhaltion, 1h) > 4167 mg/m³ air.

Executive summary:

In an acute inhalation toxicity study male Wistar rats were exposed to the test-substance in a dose of 4167 mg/m³ air.

No signs of intoxication during the one hour exposure time or the 7 days post exposure observation period could be observed.

Therefore the LC 50 was > 4167 mg/m³ air/1h.

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

Test material form:

solid

Specific details on test material used for the study:

- 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:

polyethylene glycol

Remarks:

Polyethylenglycol 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

Remarks on result:

other: No mortality occured

Mortality:

Deaths did not occur at the doses specified.
See "Remarks on results tables and figures".

Clinical signs:

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 to be r

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

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (oral, rat) > 2250 mg/kg bw.

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.