Rye, ext.

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:

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

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

Test material information

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 results

Test results 1

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

Test results 2

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

Test results 3

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

Test results 4

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

Test results 5

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.