Cyclododeca-1,5,9-triene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study and Test procedure was in accordance with generally accepted scientific standards and described in sufficient details.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Robust summary for 1,5,9-cyclododecatriene (revised).

Author:

DuPont Safety, Health & Environmental Excellence Center, Wilmington (Del., USA)

Year:

2003

Bibliographic source:

U.S. EPA, 46 pp

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was evaluated for mutagenic activity with and without exogenous metabolic (S9) activation. Three replicates were plated for each tester strain, test concentration, and condition. Dimethyl sulfoxide (DMSO) was used as the solvent and negative control.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,5,9-cyclododecatriene

IUPAC Name:

1,5,9-cyclododecatriene

Details on test material:

1,5,9-cyclododecatriene, purity 100%

Method

Target gene:

Operon His

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA97a, TA98, TA100, TA1535; E. coli strain WP2 uvrA (pKM101)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

0; 10; 50; 100; 500; 1000; 2500; 5000 ug/plate

Vehicle / solvent:

dimethyl sulfoxide (DMSO)

Controls

Untreated negative controls:

yes

Remarks:

solvent (vehicle) DMSO

Negative solvent / vehicle controls:

yes

Remarks:

DMSO (see "Negative control")

True negative controls:

no

Positive controls:

yes

Remarks:

2-aminoanthracene, 2-nitrofluorene, sodium azide, ICR 191  acridine, methyl methanesulfonate; solvent DMSO except last three  positive controls: deionized water

Positive control substance:

other: 2-aminoanthracene, 2-nitrofluorene, sodium azide, ICR 191  acridine, methyl methanesulfonate; solvent DMSO except last three  positive controls: deionized water

Details on test system and experimental conditions:

SYSTEM OF TESTING
- Metabolic activation system:   arochlor induced rat liver S9 mix ADMINISTRATION: 
Treatments with exogenous metabolic activation were conducted by adding 0.1 mL of negative control or test substance solution, 0.5 mL of S9 mix, and 0.1 mL of an overnight culture containing at least 1 x 108 bacteria to 2 mL agar. These components were mixed and poured onto a plate containing approximately 25 mL of Davis minimal agar with dextrose (minimum agar plates). Treatments without activation were identical to those with activation, with the exception that the S9 mix was replaced with 0.5 mL of sterile phosphate buffered saline. Revertant colonies were counted after the individually labeled plates were incubated at approximately 37ºC for about 48 hours. When necessary, plates were refrigerated at approximately 2-4°C prior to counting.
- Number of replicates: 3
- Application: solvent dimethyl sulfoxide
- Positive and negative control groups and treatment:    positive: 2-aminoanthracene, 2-nitrofluorene, sodium azide, ICR 191  acridine, methyl methanesulfonate; solvent DMSO except last three  positive controls: deionized water; negative: DMSO (solvent)

-further details: see reference

Evaluation criteria:

number of revertants in any strain at any test substance concentration studied was at least 2 times greater than the average number of revertants in the negative control, and there was a positive dose-response relationship in that same strain. A test substance was classified as negative when there were no test substance concentrations with an average number of revertants that was at least 2 times greater than the average number of revertants in the negative control and there was no positive dose-response relationship.

Statistics:

No. For each tester strain, the average number of revertants and the standard deviation at each concentration with and without S9 activation were calculated.

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA97a, TA98, TA100, TA1535; E. coli strain WP2 uvrA (pKM101)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: not reported

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

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

In this Ames test, no evidence of mutagenic acitivity was detected with or without metabolic activation.

Executive summary:

The test substance was evaluated for mutagenic activity with and without exogenous metabolic (S9) activation. Three replicates were plated for each tester strain, test concentration, and condition. Dimethyl sulfoxide (DMSO) was used as the solvent and negative control. Four Salmonella typhimurium strains (TA97a, TA98, TA100, TA1535) and E. coli strain WP2 uvrA (pKM101) were used in this test, and the tested concentrations were 0; 10; 50; 100; 500; 1000; 2500; 5000 ug/plate.

There was no evidence of mutagenic acitivity was detected with or without metabolic activation in this Ames Test.