Icos-1-ene

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 based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1980-10

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

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

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

Method

Target gene:

Not applicable

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:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

Migrated to IUCLID6: 4-nitroquinoline-N-oxide and sodium azide also used.

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
- Expression time (cells in growth medium): Not reported
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable

SELECTION AGENT (mutation assays): Not reported

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: Not reported

DETERMINATION OF CYTOTOXICITY
- Method: Not reported

OTHER EXAMINATIONS: Not applicable

Evaluation criteria:

Cultures were assessed for number of revertant colonies.

Statistics:

Not reported

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 specified

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:

valid

Untreated negative controls validity:

not specified

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 specified

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 specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not applicable
- Effects of osmolality: Not applicable
- Evaporation from medium: Not applicable
- Water solubility:Not applicable
- Precipitation: Not applicable
- Other confounding effects: Not applicable

RANGE-FINDING/SCREENING STUDIES: Not reported
COMPARISON WITH HISTORICAL CONTROL DATA: Not reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: Not reported

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

No tables are included because all results were negative.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

In an in vitro bacterial mutation assay, alpha C12 product 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 (WP₂ and WP₂uvrA) were exposed to alpha C12 product 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. A preliminary study to assess bacterial cytotoxicity to determine appropriate doses was not performed.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because no GLP statement was included and although the study adhered to most of the principles outlined in OECD 471, a few study deficiencies were noted.