Registration Dossier
Registration Dossier
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EC number: 438-670-5 | CAS number: 87199-17-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- May, 2017. Because of in the NDA 01-04-1385-00 carried out by Germany was not requested to indicate the endpoint study record, considering the data inserted in the course of the assessment to be correct and exhaustive the proper “Adequacy of study” has been selected.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Guideline:
- other: UK EMS Guidelines (1990)
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cytogenicity (B10)
Test material
- Reference substance name:
- -
- EC Number:
- 438-670-5
- EC Name:
- -
- Cas Number:
- 87199-17-5
- Molecular formula:
- Hill formula: C7H7BO3 CAS formula: C7H7BO3
- IUPAC Name:
- (4-formylphenyl)boronic acid
- Test material form:
- solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Human lymphocytes
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 734.6 ... 1499 µg/ml
Concentration range in the main test (without metabolic activation): 355.7 ... 632.4 µg/ml - Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 20 hours
Fixation time:
20 und 44 h
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes: Human
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (734.6 μg/ml)
- Species / strain:
- lymphocytes: Human
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (734.6 μg/ml)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
no significant results without metabolic activation
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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