4-nitrotoluene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxic hazards evaluation of five atmospheric pollutants from army ammunition plants.

Author:

Kinkead ER, MacEwen JD, Haun CC, Vernot EH

Year:

1977

Bibliographic source:

US AMBRD: TR 7703, NTIS ADA043957

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

1977

Reference 3

Reference Type:

secondary source

Title:

4-Nitrotoluene - CAS N°: 99-99-0 - SIDS Initial Assessment Report.

Author:

OECD

Year:

2003

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Analytical purity not reported. Animal housing conditions not reported. Only one dose concentration tested

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

Test type:

standard acute method

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): p-nitrotoluene
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Sprague-Dawley and CFE rats

Sex:

male

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: air

Details on inhalation exposure:

p-nitrotoluene was tested by a static technique whereby an excess of the compound was sealed into a 120-liter plexiglass chamber for a period of 24 hours (the saturation conc. at 22 °C were calculated from Antoine equation). The experimental animals were then rapidly introduced into the chamber by means of a sliding cage drawer designed to minimize vapour loss. All exposures were continuously analyzed using a Beckman Model 400 total hydrocarbon analyzer.

Duration of exposure:

4 h

Concentrations:

152 ppm (67 % of saturation) = 851 mg/m³

No. of animals per sex per dose:

10

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for sings of toxicity and mortality during exposure and for the 4-days immediately following exposure. Animals were weighed immediately prior to exposure and again at 14 days postexposure on survivors
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, grosspathology

Statistics:

Determination of the LC50 was made by probit method (Finney, 1952, Probit Analysis, 2nd Edition, King Review Press)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 851 mg/m³ air

Exp. duration:

4 h

Body weight:

All animals gained weight normally during the 14-day observation period.

Any other information on results incl. tables

No death occurred during exposure or during the subsequent 14-d observation period. Gross pathologic examination of rats sacrificed after  14 days revealed no leasions which could be attributed to exposure (no  further information given)

Applicant's summary and conclusion

Executive summary:

Kinkead (1977):

10 rats were exposed to an atmosphere essentially saturated with 4-nitrotoluene for four hours (rat: 152 ppm = 851 mg/m³) according to a method similar to OECD guideline 403 with deviations (Analytical purity not reported. Animal housing conditions not reported. Only one dose concentration tested). All animals were observed for signs of toxicity and mortality during exposure and for the 14-days immediately following exposure. Animals were weighed immediately prior to exposure and again at 14 days postexposure on survivors.

Determination of the LC50 was made by probit method (Finney, 1952, Probit Analysis, 2nd Edition, King Review Press).

No death occurred during exposure or during the subsequent 14 day post exposure observation period. No lesions attributable to exposure could be discovered during gross pathological evaluation, neither in rats nor in mice.

LC50 was estimated to be 851 mg/m³

On the basis of these results 4 -nitrotoluene can be classified as T; R23, toxic by inhalation and Acute Tox 3 H331 (Toxic if inhaled).