Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other: secondary source
Title:
Unnamed
Year:
1996

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: see reference
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

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

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA97a, TA98, TA100, TA1535; E. coli strain WP2 uvrA (pKM101)
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:
Ames test

SYSTEM OF TESTING
- Metabolic activation system:   arochlor induced rat liver S9 mix ADMINISTRATION: 
- 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:
CRITERIA FOR EVALUATING RESULTS: Positive if the average number of  revertants in any strain at any test substance concentration studied was  at least 2 times greater than the average of the negative control, and  there was a positive dose-response relationship in that same strain.
Statistics:
no data

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
Additional information on results:
see reference

Applicant's summary and conclusion

Conclusions:
The test substance proved to be non-mutagenic in this bacterial reverse mutation assay.