N-[3-(dimethylamino)propyl]oleamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD guideline 423 and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]oleamide

EC Number:

203-661-5

EC Name:

N-[3-(dimethylamino)propyl]oleamide

Cas Number:

109-28-4

Molecular formula:

C23H46N2O

IUPAC Name:

(9Z)-N-[3-(dimethylamino)propyl]octadec-9-enamide

Test material form:

other: liquid

Details on test material:

Name of test material (as cited in study report): Oleic acid, N-(3-dimethylaminopropyl)-amide, cis/trans-isomer
Physical state: yellow liquid (at room temperature)
Batch number: R401/57
Composition: 89% Oleic acid, N-(3-dimethylaminopropyl)-amide, cis/trans-isomer
Impurities: ca. 10% oleic acid

Purity of test item was considered to be 100% for the study.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Supplier: Elevage JANVIER
Age at beginning of study: 8 weeks
Weights of treated animals: 192-207 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Administration volume: 2.27 ml/kg bw (test substance), 2.0 ml/kg bw (control item)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

Study was performed as a limit test. The six animals in the treated group (2000 mg/kg) were tested sequentially in groups of three.

EXAMINATION OF THE ANIMALS:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. Mortality was determined every day.
The animals were weighed on day D0 (just before administering the test item), and then on D2, D7, and D14. Weight changes were calculated and recorded.
On D14, the animals were anaestetised with sodium phenobarbital, and administration continued to fatal levels.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One animal from the treated group was found dead 48 hours after administration of the test substance.

Body weight:

The body weights of the rats treated with the test substance decreased by 10.1% within 48 hours after administration of the test substance, but developed normally thereafter (similar body weights in treated and control animals).

Gross pathology:

Necropsy revealed no abnormal findings, except for the following abnormalities in the stomach of animals treated with the test substance: White granular thickening on the forestomach in 5 rats, red/black foci on the forestomach and red coloration on the corpus in 1 rat.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The test item Trennmittel ZM 121 was administered orally as a single dose of 2000 mg/kg bw to 6 female Sprague Dawley rats, following OECD guideline 423 to assess its potential acute oral toxicity. Mortality was observed in one animal treated with the test substance 48 hours after administration of the test substance. Macroscopical examination of this animal revealed red coloration on the corpus and the presence of red/dark foci on the forestomach.

A general decrease of spontaneous activity was observed in all treated animals on day 2 and day 3 of the study and piloerection in 2 treated animals on day 2 of the study. Body weight changes of the treated rats decreased by 10.1% 48 hours after administration of the test item but recovered thereafter. Macroscopical examination of the surviving animals at the end of the study revealed a white granular thickening on the forestomach.

In conclusion, the LD50 was determined to be >2000 mg/kg bw via the oral route.