Amines, C16-18-alkyl

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

17 Dec 1984 - 22 Jul 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed according to acceptable standards including GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

yes

GLP compliance:

yes

Type of assay:

other: In Vitro Mammalian Cell Gene Mutation 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:

CH3(CH2)7CH=CH(CH2)7CH2NH2

IUPAC Name:

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-11-27-94

Method

Target gene:

hypoxanthine-guanine phosphoribosyl-transferase locus

Species / strain

Species / strain / cell type:

other: Chinese hamster Ovary (CHO-K2-BH4 cells)

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 ; 2 days after injection, the livers were excised and prepared

Test concentrations with justification for top dose:

first assay:
without metabolic activation: 0.1, 0.5, 1.0, 1.5, 2.0 nL/mL
with metabolic activation: 9.0, 8.0, 7.0, 6.0, 5.0 nL/mL

second assay:
without metabolic activation: 2.0, 1.5, 1.0 nL/mL
with metabolic activation: 10.0, 9.5, 9.0, 8.0, 7.0 nL/mL

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: ethylmethanesulphonate and benzo(a)pyrene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 5 h
- Expression time (cells in growth medium): 7-9 days
- Selection time (if incubation with a selection agent): 7 days

SELECTION AGENT (mutation assays): 6-thioguanine
STAIN (for cytogenetic assays): Giemsa

NUMBER OF REPLICATIONS:
preliminary toxicity test: single culture per treatment
mutation assay: duplicate cultures per treatment

NUMBER OF CELLS EVALUATED: cloning efficiency: 100 cells; mutation assay: 2000 cells or 10000 cells

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency

Evaluation criteria:

The assay is considered positive in the event a dose-dependent increase in mutation frequency is observed with one or more of th four concentrations tested inducing a mutation frequency which is at least twice that of the solvent control. The assay is considered suspect if there is no dose response but one or more doses induce a mutation frequency which is at least twice that of the solvent control.
The positive control must induce a mutation frequency at least three time that of the solvent control.

Results and discussion

Test results

Species / strain:

other: Chinese hamster Ovary (CHO-K2-BH4 cells)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

≥2.25 nL/mL (without S9); ≥10 nL/mL (with S9)

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 is considered to be negative in the hgpr test either with or without exogenous metabolic activation.

Executive summary:

Mutagenicity of octadecenylamine (ODA-FG-11 -27 -84) at the hprt locus was investigated in Chinese hamster ovary cells at concentrations of 0.1 to 2.0 nl/ml without S-9 mix and of 5.0 to 10 nl/ml with S-9 mix. No relevant cytotoxicity (decrease in cloning efficiency) was found for the analysed concentrations; without S-9 mix concentrations higher than 2.0 nl/ml led to strong cytotoxicity so that cloning was not successful. In general, there was no increase in mutation frequencies after treatment, with the exception of the highest concentrations of 2.0 nl/ml (without S-9 mix) and 9.0 nl/ml (with S-9 mix) in the first experiment. Since no genetic effects were seen at lower concentrations and the second experiments were clearly negative with and without S-9 mix, these increased mutation frequencies can be interpreted as outliers (due to the low statistical power of this test system). Altogether, the test result is negative.