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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.