Pentadecane, 7-methylene-

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study report is classified as reliable with restrictions because while there is no statement regarding whether these studies were conducted according to GLPs or equivalent, the study appears to have been conducted in general accordance with OECD 471 guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dodec-1-ene

EC Number:

203-968-4

EC Name:

Dodec-1-ene

Cas Number:

112-41-4

IUPAC Name:

dodec-1-ene

Details on test material:

- Name of test material (as cited in study report): Alpha C12 Product
- Substance type: C12 alpha olefin
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: G.E.P. 78.4044
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Reported to be at least 4 hours
- Storage condition of test material: Not reported
- Other: Prepared in acetone
- Molecular formula (if other than submission substance): C12H24
- Molecular weight (if other than submission substance): 168.3
- Smiles notation (if other than submission substance): CCCCCCCCCCC=C
- InChl (if other than submission substance): InChI=1S/C12H24/c1-3-5-7-9-11-12-10-8-6-4-2/h3H,1,4-12H2,2H3

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not specified

Species / strain 3

Species / strain / cell type:

E. coli WP2

Additional strain / cell type characteristics:

not specified

Species / strain 4

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction obtained from liver homogenate from Arochlor induced rats

Test concentrations with justification for top dose:

0, 0.2, 2.0, 20, 200, and 2000 micrograms/plate

Vehicle / solvent:

Vehicle(s)/solvent(s) used: Acetone
Justification for choice of solvent/vehicle: Not reported

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

sodium azide

benzo(a)pyrene

Details on test system and experimental conditions:

METHOD OF APPLICATION: In medium; in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours at 37 degrees Celsius

NUMBER OF REPLICATIONS: 2

Evaluation criteria:

Cultures were assessed for number of revertant colonies.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No tables are included because all results were negative.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

In an in vitro bacterial mutation assay, dodec-1-ene was not mutagenic to five strains of Salmonella typhimurium or two strains of Escherichia coli in the presence or absence of metabolic activation.

Executive summary:

In a reverse gene mutation assay in bacteria, five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, and TA1538) and 2 strains of Escherichia coli (WP2and WP2uvrA) were exposed to dodec-1 -ene in acetone at concentrations of 0, 0.2, 2, 20, 200, or 2000 µg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method. No increase in reverse mutation rate was noted in either assay in the presence or absence of metabolic activation. This study can be considered as part of a weight of evidence approach to predicting the genotoxic potential of the substance 7 -methylenepentadecane.