Cyclododecanone

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

Study period:

1987-11-20 to 1987-11-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions: Incomplete documentation, TA 102 or E.coli WP2 were not tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Principles of method if other than guideline:

other: Ames BN et al. (1975). Mutat. Res. 31, 347-364

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Cyclododecanone

EC Number:

212-595-6

EC Name:

Cyclododecanone

Cas Number:

830-13-7

Molecular formula:

C12H22O

IUPAC Name:

cyclododecanone

Details on test material:

Cyclododecanone of Hüls AG, ID 424/870826, purity not reported

Method

Target gene:

mutated gene loci responsible for histidine auxotrophy

Species / strain

Species / strain / cell type:

S. typhimurium, other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100

Additional strain / cell type characteristics:

other: histidine auxotroph

Metabolic activation:

with and without

Metabolic activation system:

 Aroclor induced rat S9 liver homogenate, male Bor: W/SW (SPF/TNO) rats

Test concentrations with justification for top dose:

10 to 5000 µg/plate

Vehicle / solvent:

DMSO dimethylsulfoxide

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

other: not reported but assumed that the vehicle dimethylsulfoxide served as control

True negative controls:

no

Positive controls:

yes

Remarks:

see below

Positive control substance:

other: 2.5 µg nitrofluorene/plate: TA 98, TA 1538 (pos.)    2.5 µg sodium azide/plate: TA 100, TA 1535 (pos.)    50 µg aminoacridine/plate: TA 1537 (pos.)  

Remarks:

enzyme activity confirmed with  aminoanthracene

Details on test system and experimental conditions:

Ames test
SYSTEM OF TESTING
- Metabolic activation system:    Aroclor induced rat S9 liver homogenate, male Bor: W/SW (SPF/TNO) rats,  enzyme activity confirmed with 
aminoanthracene
ADMINISTRATION: 
- Solvent: dimethyl sulfoxide (CAS No. 67-68-5)
- Positive and negative control groups and treatment:    
2.5 µg nitrofluorene/plate: TA 98, TA 1538 (pos.)   
2.5 µg sodium azide/plate: TA 100, TA 1535 (pos.)   
50 µg aminoacridine/plate: TA 1537 (pos.)  
negative: untreated plus solvent (not reported but assumed)
- Number of replicates: 2 - Pre-incubation: with and without  metabolic activation

Evaluation criteria:

CRITERIA FOR EVALUATING RESULTS:    mutagenic effects (i.e  ratio of revertant rates treated/control >= 2)  at <= 5000 µg/plate with generally 
positive dose-response relationship in  any strain

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: at >= 1000 or >= 2500 µg/plate, respectively

Additional information on results:

no further information

Remarks on result:

other: other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance cyclododecanone proved to be non-mutagenic under the conditions of this study, both in the presence and in the absence of Aroclor-induced liver microsomes for all the test strains even in addition of 5,000 µg of test substance per plate and when the pre-incubation test was used.

Executive summary:

The test substance cyclododecanone was tested in the Ames Salmonella/microsomes mutagenicity test for any mutagenic activity. The test organisms were five histidine-auxotrophic Salmonella typhimurium strains. The test substance concentrations were in the range between 10 and 5,000 µg/plate. The test substance cyclododecanone proved to be non-mutagenic under the conditions of this study, both in the presence and in the absence of Aroclor-induced liver microsomes for all the test strains even in addition of 5,000 µg of test substance per plate and when the pre-incubation test was used.