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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dienyl]phenol
EC Number:
685-515-4
Cas Number:
10309-37-2
Molecular formula:
C18H24O
IUPAC Name:
4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dienyl]phenol

Method

Target gene:
Salmonella typhimurium
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
0.079, 0.157, 0.313, 0.625, and 1.25 μl/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO.
- Justification for choice of solvent/vehicle: the test substance being immiscible in millipore water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
mitomycin C
Remarks:
With S9, Benzo(a)pyrene (1 μg/plate) for all five strains; Without S9, Mitomycin C (0.5 μg/plate) -TA102; Sodium azide (1 μg/plate) - TA100 and TA1535; 2 - Nitrofluorene (10 μg/plate) - TA98; 9 - Aminoacridine (50 μg/plate) - TA1537
Evaluation criteria:
A test substance was considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA102) or thrice (strains TA1535 and TA1537) the colony counts of the corresponding solvent control was observed. The number of revertant colonies per plate, its frequency, the statistical significance of any increase in any of the strain and its correlation to the test concentration in a given time period, was
considered for evaluating the mutagenic potential of the test substance. Though, the final decision was based upon scientific judgement.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative