Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Rye, ext.
EC Number:
290-271-3
EC Name:
Rye, ext.
Cas Number:
90106-48-2
IUPAC Name:
Oligosaccharides and polysaccharides of glucose from Rye
Test material form:
liquid
Details on test material:
BATCH: 5.180.1
Liquid limpid
Color: yellow
Storage Condition: Room temperature

Method

Target gene:
His locus (for S. tyhimurium strains) and Trp locus (for E.coli strain)
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Details on mammalian cell type (if applicable):
uvrB for the S;typhimurium strains and uvrA for E.coli
pKM101 for S.typhimurium TA 98, TA 100 and E.coli WP2
rfa for S.typhimurium strains
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
10% S9 ( rat liver microsome fraction) mix : S9 fraction, Mg-aspartate (8mM), KCl (33mM), Glucose-6-Phosphate (5mM), NADPNa2 (4mM) and Phosphate Buffer pH7.4 (0.1mM)
Test concentrations with justification for top dose:
Dose per plate: 5 µL, 1.5 µL, 0.5 µL, 0.15 µL, 0.05 µL with and without S9-mix in TA 98, TA 100, TA 1535 , TA 1537, Echerichia Coli WP 2 stain
Vehicle / solvent:
The test item was mixed with top agar containing 10% (v/v) of L-Histidine-D-Biotine (0.25 µm)
Controls
Untreated negative controls:
yes
Remarks:
absolute negative control (spontaneous reversion rate)
True negative controls:
yes
Positive controls:
yes
Remarks:
Control mutagene were used for each strain
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-aminoanthracene
Details on test system and experimental conditions:
Incubation of 48h at 37°C.
3 replicates per concentration of test item.
Rationale for test conditions:
Refer to Guideline criteria.
Evaluation criteria:
Number of spontaneous revertant colonies in the presence of the test item
Dose-response relationship
Statistics:
Not specified

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:
no cytotoxicity
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:
no cytotoxicity
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:
no cytotoxicity
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:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Validity criteria for the study were fulfilled.

Applicant's summary and conclusion

Conclusions:
The test item BIO & TENS was found to be non mutagenic and non pro-mutagenic under the test conditions.
Executive summary:

In accordance with OECD Guideline 471 and the test Method B13/B14 of Commission Directive 2000/32/EC, a test was performed in the test item which was found to be non mutagenic and non pro-mutagenic under the test conditions.