Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well documented publication
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Primary Mutagenicity Screening of Food Additives Currently used in Japan
Author:
Ishidate M Jr., Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M, and Matsuoka A
Year:
1984
Bibliographic source:
Fd. Chem. Toxic. 22: 623-636
Reference Type:
secondary source
Title:
No information
Author:
Ishidate M Jr., Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M, and Matsuoka A
Year:
2008
Bibliographic source:
RIFM database
Reference Type:
secondary source
Title:
Unnamed
Year:
2001

Materials and methods

Principles of method if other than guideline:
Method according to Ames, McCann & Yamasaki (1975)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Geraniol
- Analytical purity: 99.4 %

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
other: TA92, TA94, TA2637
Metabolic activation:
with and without
Metabolic activation system:
polychlorinated biphenyls induced rat liver microsome S9 mix
Test concentrations with justification for top dose:
up to 0.5 mg/ plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min, 37°C
- Exposure duration: 48 h, 37°C

NUMBER OF REPLICATIONS: 2
Evaluation criteria:
The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).

Results and discussion

Test resultsopen allclose all
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 specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: TA92, TA94, TA2637
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
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