Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented non-GLP study performed according to a method similar to OECD Guideline 403 with some minor deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

no monitoring of chamber airflow, no actual concentration measured, no information on relative humidity

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine

EC Number:

272-789-1

EC Name:

Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine

Cas Number:

68911-83-1

Molecular formula:

C40H76N2O

IUPAC Name:

Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine

Details on test material:

- Name of test material (as cited in study report): 46 c

Test animals

Species:

rat

Strain:

other: Albino rats

Sex:

male

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

The rats were placed in a 70 liter, all glass exposure chamber and exposed to a saturated atmosphere of the test material in air for one hour. The material was administered as an aerosol with particles 3-5 microns in diameter.
The rate of flow was 12.2 liters per minute at a temperature of 72°F.
The air was passed through a desicant prior to bing passed through the test material. By differential weighing it was calculated that the rats were subjected to a concentration of 3.1 mg/liter during the exposure period. This is an average value over the one hour period.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Concentrations:

By differential weighing it was calculated that the rats were subjected to a concentration of 3.1 mg/liter during the exposure period. This is an average value over the one hour period.

No. of animals per sex per dose:

One group of ten male, albino rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: no data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

3.1 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

1 h

Mortality:

Three rats died during the first 24 hour period after exposure. A 4th rat died during the 2nd day after exposure. There were no further deaths during the 14 day observation period.

Clinical signs:

other: The rats showed slow, labored breathing and were inactive during the exposure period.

Body weight:

No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

From the results obtained in this study, it appears that the substance would be considered to be toxic but not highly toxic by the inhalation route of administration since the LC50 is approximately 3.1 mg/liter.