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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Scientific Opinion on the safety and efficacy of Biogalactosidase BL (alphagalactosidase and beta-glucanase) as feed additive for chickens for fattening
Author:
EFSA
Year:
2011
Bibliographic source:
EFSA Journal 2011;9(12):2451

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Remarks:
Not reported in this summary report
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Glucanase, β-
EC Number:
232-979-7
EC Name:
Glucanase, β-
Cas Number:
9074-98-0
Molecular formula:
not available (see remarks)
IUPAC Name:
endo-1,4-ß-glucanase IUBMB EC 3.2.1.4
Specific details on test material used for the study:
- Name as used in study report: glucanase: Enzyme ZS

Method

Target gene:
- S. typhimurium: his
- E. coli: trp
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
maximum concentration 5000 µg/plate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
A bacterial reverse mutation test was carried out in a plate incorporation test and a pre-incubation test, with and without metabolic activation.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA 1535, 1537, 98, 100 and 102
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:
not specified
Species / strain:
E. coli WP2 uvr A
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:
not specified
Additional information on results:
These studies did not indicate a genotoxic potential.

Applicant's summary and conclusion