Diethylmethylbenzenediamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Study period:

No information is available on the study period, other than the date the report was finalized (6 April 1978).

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was performed prior to the implementation of Good Laboratory Practice standards and prior to the adoption of of OECD Test No. 403 Acute Inhalation Toxicity. The test parameters are, however, well documented and scientifically acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1972

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

not applicable

Principles of method if other than guideline:

Animals were exposed (whole body) to aerosolized test material for one hour. Nominal exposure concentrations were determined by the weight difference of the flask, nebulizer, and tubing pre- and post-exposure. Animals were monitored for toxic signs continuously during the exposure period, hourly post-exposure up to four hours, and daily thereafter for 14 days. Individual body weight data were obtained on day 0, 1, 2, 4, 7, and 14. Gross necropsies were performed on all surviving animals at study termination.

GLP compliance:

no

Remarks:

This study was performed prior to the implementation of GLP standards.

Test type:

fixed concentration procedure

Test material

Test material information

Constituent 1

Reference substance name:

Diethylmethylbenzenediamine

EC Number:

270-877-4

EC Name:

Diethylmethylbenzenediamine

Cas Number:

68479-98-1

Molecular formula:

C11H18N2

IUPAC Name:

diethylmethylbenzenediamine

Details on test material:

The test material was in the form of a dark brown, viscous liquid.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The test animals were received from Charles River Breeding Laboratories and consisted of five male and five female Sprague-Dawley rats, weighing between 206 and 274 grams. No further details were reported.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

The test material was placed in a 500-ml, 3-neck flask fitted with a Laskin nebulizer. Dry air was passed through the nebulizer at a flow rate of 7.0 liters per minute and the resulting aerosol was then passed directly into a 26.5-liter, glass exposure chamber containing the test animals. The exposure lasted for 1.0 hour. The 3-neck flask, including the test material, nebulizer and air tubing, was weighed before and after the exposure period to determine the nominal exposure concentration.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The 3-neck flask, including the test material, nebulizer and air tubing, was weighed before and after the exposure period to determine the nominal exposure concentration.

Duration of exposure:

>= 1 h

Concentrations:

Nominal exposure concentration of 2.45 milligrams per liter.

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Whole body exposure to the test article took place for one hour, during which time the animals were observed for signs of toxicity. Upon removal from the exposure chamber, hourly post-exposure observations were made for four hours and daily thereafter for 14 days. Individual body weight data were recorded on Days 0 (day of exposure), 1, 2, 4, 7 and 14 (terminus). On Day 14, all animals were sacrificed (ethyl ether) and gross necrops examinations were performed.

Statistics:

No statistics were reported.

Results and discussion

Preliminary study:

During the exposure period, a total of 1.03 grams of test material was delivered, yielding a nominal exposure concentration ot 2.45 milligrams per liter.

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.45 mg/L air (nominal)

Exp. duration:

1 h

Mortality:

No mortalities occurred during the study.

Clinical signs:

other: By 15 minutes into the exposure, nearly all of the test animals exhibited excessive salivation, excessive lacrimation and mucoid nasal discharge. By 30 minutes all were inactive and some test animals exhibited labored breathing. These signs continued for

Body weight:

Individual body weight data were considered to be normal. Male and female rats gained an average of 76 or 20 grams, respectively, from day 0 to day 14.

Gross pathology:

Necropsy examination revealed lung discoloration (mottled light and dark red, occassionally with red or white spotting) in seven of ten animals.

Applicant's summary and conclusion

Conclusions:

A one-hour whole-body exposure to 2.45 mg/l (336 ppm) was not acutely toxic to male or female rats.

Executive summary:

A 1.0 hour exposure to an aerosol of DETDA at a nominal exposure concentration of 2.45 milligrams per liter (336 ppm), did not produce mortality in rats so exposed. The exposure did produce signs of immediate toxicity, which tended toward recovery when the animals were removed from the chamber. A high incidence of lung discoloration at the necropsy indicated the possibility of some residual effects.