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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Principal key study on "Evaluation of the Mutagenic Activity of Hop Extract in the Salmonella typhimurium Reverse Mutation Assay and the Escherichia coli Reverse Mutation Assay (Plate Incorporation and Pre-Incubation Methods)" peformed in 2017 according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Key study: The objective of this study was to determine the potential of Hop Extract 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 design of this study is based on the following study guidelines:
• OECD Guideline 471. Genetic Toxicology: Bacterial Reverse Mutation Test. (Adopted July 21, 1997).
• EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.13/14: "Mutagenicity: Reverse Mutation Test using Bacteria”. Official Journal of the European Union No. L142, 31 May 2008.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Hop, Humulus lupulus, ext.
EC Number:
232-504-3
EC Name:
Hop, Humulus lupulus, ext.
Cas Number:
8060-28-4
Molecular formula:
No simple molecular formula for UVCB
IUPAC Name:
Hop, Humulus lupulus, ext.
Test material form:
liquid: viscous
Remarks:
Depending on the extraction conditions and on the hop variety, the colour of the extract can vary from yellow to dark green. It is a semi-fluid paste at room temperature. The product becomes more fluid when heated.
Specific details on test material used for the study:
Key study: Hop extract. Batch no. 16/4021. Dark green/brown resin; UVCB.

Method

Target gene:
Key study: The objective of this study was to determine the potential of Hop Extract 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).
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Key study: 1600 ug per plate. Initial range finding showed that 5000 ug per plate caused precipitation of hop extract.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
2-nitrofluorene
sodium azide
methylmethanesulfonate

Results and discussion

Test results
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

Applicant's summary and conclusion

Conclusions:
Key study: Hop Extract is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

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