C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

09 Jan - 02 Apr 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed according to acceptable standards including GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

yes

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

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:

(Z)-octadec-9-en-1-amine

Constituent 2

Reference substance name:

(Z)-octadec-9-en-1-amine

IUPAC Name:

(Z)-octadec-9-en-1-amine

Constituent 3

Reference substance name:

Oleyl Alkylamines

IUPAC Name:

Oleyl Alkylamines

Details on test material:

- Name of test material (as cited in study report): ODA-FG-11-27-84

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 homogenate: from adult male Sprague-Dawley rats that had been injected with Aroclor 1254 at 500 mg/kg bw ; 5 days after injection, the livers were excised and prepared

Test concentrations with justification for top dose:

without metabolic activation: 0.05, 0.15, 0.5, 1.5, 5 nL/mL
with metabolic activation: 0.2, 0.6, 2, 6, 20 nL/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: triethylenemelamine and cyclophosphamide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period in growth medium: 18-24 h
- Exposure duration: without S9 mix: 16 h; with S9 mix: 2 h
- Expression time (cells in growth medium): 14 h (only for the activated cells)
- Fixation time (start of exposure up to harvest of cells): 18.5 h

SPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.1 µg/mL)
STAIN (for cytogenetic assays): 5% Giemsa

NUMBER OF REPLICATIONS: all assays in duplicate

NUMBER OF CELLS EVALUATED: 100 cells (50 cells/duplicate)

DETERMINATION OF CYTOTOXICITY
- Method: The cytotoxic effects of treatment are expressed relative to the solvent-treated control (relative cell survival).

Evaluation criteria:

Chi-square-analysis using 2x2 contingency table was used to ascertain significant differences between the number of cells with aberrations in the treatment and control groups.
The number of cells with chromosome aberrations in the positive control must be at least 25% of the cells scored.

Statistics:

chi-square-test

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation: at 5 nL/mL; with metabolic activation: at 20 nL/mL

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material octadecenylamine was not mutagenic in an in vitro chromosomal aberration test in CHO cells either with or without exogenous metabolic activation.

Executive summary:

Octadecenylamine (ODA-FG-11-27-84) did not induce chromosomal aberrations in CHO cells in the absence and presence of aroclor 1254 induced Sprague dawley rat liver S-9 mix. Cells were treated with0.05to 5 nl/ml of the test substance in the absence of S-9 mix and with 0.2 to 20 nl/ml in the presence of S-9 mix. Cell survival was reduced to 24% with and without S9 mix at the highest concentrations tested. The positive and negative controls fullfilled the requirements for a valid test.