Registration Dossier
Registration Dossier
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EC number: 232-979-7 | CAS number: 9074-98-0
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- other: in vivo mouse micronucleus 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
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- maximum dose used
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Positive control(s):
- not specified
Examinations
- Details of tissue and slide preparation:
- immature erythrocytes from bone marrow
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No evidence for genotoxicity was observed in this test.
Applicant's summary and conclusion
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