Registration Dossier
Registration Dossier
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EC number: 232-979-7 | CAS number: 9074-98-0
Genetic toxicity: in vitro
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:
- 2 011
- 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
- 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
Constituent 1
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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