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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles, limited documentation (results in summary table only)

Data source

Reference
Reference Type:
publication
Title:
Study of artificial flavouring substances for mutagenicity in the Salmonella/microsome, basc and micronucleus tests
Author:
Wild D, King MT, Gocke E and Eckhardt K
Year:
1983
Bibliographic source:
Food and Chemical Toxicology, 21(6), 707-719

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
e.g. strains used
Principles of method if other than guideline:
acc. to Ames B. N ., McCann J . & Yamasaki E . (1975) . Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test . Mutation Res . 31, 347 .
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Supplier: ICN-K&K, Plainview, NY, USA
No further data given

Method

Target gene:
histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9 mix
Test concentrations with justification for top dose:
up to 3.6 mg/plate
Vehicle / solvent:
No data
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: 0.5 µg/plate; for TA 1535, TA 100
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 5 µg/plate; T1 100, TA 1537, TA 1538, TA 98
Details on test system and experimental conditions:
METHOD OF APPLICATION: standard plate test, preincubation test (not specified for hydroxycitronellal)


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

NUMBER OF REPLICATIONS: at least 2
Evaluation criteria:
Positive, if a reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency was observed
Agents producing reproducible, dose-related and significant but less than two-fold elevations were classified as marginally mutagenic under the experimental conditions.

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:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Resutls given in tabular form only.

A structurally and metabolically related substance was tested under comparable testing conditions:

Hydroxycitronellol (CAS. 107-74-4): negative

Applicant's summary and conclusion