Reaction mass of cyclododecanol and cyclododecanone

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Study period:

1987-11-25 to 1987-12-04

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:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Method: 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:

Cyclododecanol

EC Number:

217-031-2

EC Name:

Cyclododecanol

Cas Number:

1724-39-6

Molecular formula:

C12H24O

IUPAC Name:

cyclododecanol

Details on test material:

Cyclododecanol of Hüls AG, ID 423/870826, purity not reported

Method

Target gene:

mutated gene loci responsible for histidine auxotrophy

Species / strain

Species / strain / cell type:

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 liver S9 mix, male Bor: W/SW (SPF/TNO) rats

Test concentrations with justification for top dose:

10 to 5000 µg/plate

Vehicle / solvent:

acetone (CAS No. 67-64-1)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

other: assumed to be performed but not reported

True negative controls:

no

Positive controls:

yes

Remarks:

details see below

Positive control substance:

other: without metabolic activation: Nitrofluorene (TA 98; TA 1538), Sodium azide (TA 100; TA 1535), Aminoacridine (TA 1537); with metabolic activation: Aminoanthracene (TA 100)

Details on test system and experimental conditions:

Ames test
SYSTEM OF TESTING
- Metabolic activation system:    Aroclor induced rat liver S9 mix, male Bor: W/SW (SPF/TNO) rats, enzyme  activity tested with aminoanthracene
ADMINISTRATION: 
- Number of replicates: 2
- Application: 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
- Pre-incubation: with and without

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: details: see "Test system"

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: at >= 250 or >= 500 µg/plate, respectively

Vehicle controls validity:

other: not reported but validity assumed

Untreated negative controls validity:

other: not reported but validity assumed

Positive controls validity:

other: not reportedabut validity assumed

Additional information on results:

no data

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 other information

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance cyclododecanol proved to be non-mutagenic under the conditions of this study, in absence and present of metabolic activation
system for all the test strains.

Executive summary:

The test substance cyclododecanol 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 5000 µg/plate. The test substance cyclododecane proved to be non-mutagenic under the conditions of this study, in absence and present of metabolic activation system for all the test strains.