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EC number: 242-016-2 | CAS number: 18127-01-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bourgeonal
- IUPAC Name:
- Bourgeonal
- Reference substance name:
- 3-(4-tert-butylphenyl)propionaldehyde
- EC Number:
- 242-016-2
- EC Name:
- 3-(4-tert-butylphenyl)propionaldehyde
- Cas Number:
- 18127-01-0
- Molecular formula:
- C13H18O
- IUPAC Name:
- 3-(4-tert-butylphenyl)propanal
- Test material form:
- other: liquid
- Details on test material:
- Identification: Bourgeonal
CAS number: 18127-01-0
Description: Clear colourless liquid
Storage conditions: At ambient temperature under nitrogen.
Batch number: VE000010051
Date of receipt: 20 November 2008
Expiry date: 4 August 2009
Purity: 98.4%
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine for Salmonella.
Tryptophan for E.Coli
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Based on the results of the first mutation experiment, BOURGEONAL was tested up to concentrations of 512 and 5000 μg/plate in the absence and presence of 10% (v/v) S9-mix in the Salmonella typhimurium and Escherichia coli strain, respectively.
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191; 2-aminoanthracene
- Details on test system and experimental conditions:
- According to OECD 471
- Rationale for test conditions:
- According to OECD 471
- Evaluation criteria:
- According to OECD 471
- Statistics:
- According to OECD 471
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, based on the results of this study it is concluded that BOURGEONAL is not
mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli
reverse mutation assay. - Executive summary:
The objective of this study was to determine the potential of BOURGEONAL and/or its
metabolites to induce reverse mutations at the histidine locus in several strains of Salmonella
typhimurium (S. typhimurium; TA98, TA100, TA1535, and TA1537), and at the tryptophan
locus of Escherichia coli (E. coli) strain WP2uvrA in the presence or absence of an exogenous
mammalian metabolic activation system (S9).
The study procedures described in this report were based on the most recent OECD, EC and
METI guidelines.
Batch SC00021197 of BOURGEONAL was a pale yellow liquid with a purity of 97.2%. The
test item was dissolved in dimethyl sulfoxide.
In the first mutation assay, the test item was tested up to concentrations of 5000 μg/plate in
the absence and presence of 5% (v/v) S9-mix. The test item precipitated on the plates at this
dose level. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of
the bacterial background lawn and/or the presence of microcolonies, was observed in all tester
strains in the absence and presence of S9-mix.
In the second mutation assay, the test item was tested up to concentrations of 512 and
5000 μg/plate in the absence and presence of 10% (v/v) S9-mix in the Salmonella
typhimurium and Escherichia coli strain, respectively. The test item precipitated on the plates
at the dose level of 5000 μg/plate. Cytotoxicity, as evidenced by a decrease in the number of
revertants, reduction of the bacterial background lawn and or the presence of microcolonies,
was observed in all tester strains in the absence and presence of S9-mix. Except for tester
strain WP2uvrA in the presence of S9-mix where no toxicity was observed.
BOURGEONAL did not induce a significant dose-related increase in the number of revertant
(His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in
the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and
presence of S9-metabolic activation. These results were confirmed in an independently
repeated experiment.
In this study, acceptable responses were obtained for the negative and strain-specific positive
control items indicating that the test conditions were adequate and that the metabolic
activation system functioned properly.
In conclusion, based on the results of this study it is concluded that BOURGEONAL is not
mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli
reverse mutation assay.
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