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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
