Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only summary in EU risk assessment available, but judged to be reliable by the authors.

Data source

Reference

Reference Type:

review article or handbook

Title:

European Union Risk Assessment Report - Primary Alkyl Amines

Author:

Germany

Year:

2008

Bibliographic source:

Published Draft, page 166

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

Test performed in 1989

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-octadec-9-enylamine

EC Number:

204-015-5

EC Name:

(Z)-octadec-9-enylamine

Cas Number:

112-90-3

Molecular formula:

C18H37N

IUPAC Name:

octadec-9-en-1-amine

Constituent 2

Reference substance name:

Reference substance 001

Details on test material:

name: Oleylamine
purity: 90%

Test animals

Species:

mouse

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil
volume: 10ml/kg

Frequency of treatment:

single dose

Post exposure period:

Cells were collected 6, 12, 24h after treatment

Doses / concentrations

Remarks:

Doses / Concentrations:
500, 2500, 5000 mg/kg
Basis:
actual ingested

No. of animals per sex per dose:

5

Examinations

Tissues and cell types examined:

bone marrow cells

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Additional information on results:

One female in the 2500 mg/kg bw group died prematurely.
No significant reduction in the rate of body weight gain was observed.
Clinical signs of toxicity were observed in test substance-treated mice indicating that the test substance was systemically available after oral application.