Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-185-2 | CAS number: 1111-78-0
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Primary Mutagenicity Screening of Food Additives Currently used in Japan
- Author:
- Ishidate M Jr., Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M, and Matsuoka A
- Year:
- 1 984
- Bibliographic source:
- Fd. Chem. Toxic. 22: 623-636
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report For SIAM 22
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD SIDS Ammonium bicarbonate
Materials and methods
- Principles of method if other than guideline:
- acc. to Ishidate & Odashima (1977)
- Cells were exposed in the absence of metabolic acivation at three doses for 24 and 48 hr. Colcemid (final concn 0.2 μg/ml) was added to the cell culture 2 hours before cell harvesting. Staining was performed with Giemsa. 100 metaphases were observed under the microscope for structural chromosomal aberrations. - GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Ammonium hydrogencarbonate
- EC Number:
- 213-911-5
- EC Name:
- Ammonium hydrogencarbonate
- Cas Number:
- 1066-33-7
- Molecular formula:
- CH2O3.H3N
- IUPAC Name:
- ammonium hydrogen carbonate
- Details on test material:
- - Name of test material (as cited in study report): Ammonium bicarbonate
- Analytical purity: no data
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster fibroblast cell line (CHL)
- Details on mammalian cell type (if applicable):
- - Source: The cell line was originally established from the lung of a newborn female hamster and was maintained by 4-day passages in Minimal Essential Medium supplemented by 10% calf serum. The modal chromosome number is 25 and the doubling time was approximately 15 hr.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Metabolic activation system:
- none
- Test concentrations with justification for top dose:
- - up to 250 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: phosphate buffer
Controls
- Untreated negative controls:
- yes
- Remarks:
- (untreated cells)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 48 h
SPINDLE INHIBITOR (cytogenetic assays): colcemid, 0.2 µg/ml
STAIN (for cytogenetic assays): Giemsa
NUMBER OF CELLS EVALUATED: 100 - Evaluation criteria:
- - The results were considered negative if the incidence of aberrations was less than 4.9%, equivocal if it was between 5.0 and 9.9%, and positive if it was more than 10.0%.
- When dose-response relationships were not found, additional experiments were carried out at similar dose levels. - Statistics:
- - For a quantitative evaluation of the clastogenic potential of positive samples, the D20 (dose in mg/ml at which structural aberrations (including gaps) were detected in 20% of metaphases observed) was determined.
- Additionally, the TR value (indicates frequency of cells with exchange-type aberrations per unit dose (mg/ml)) was calculated.
- A high TR value exists for chemicals that show carcinogenic potential in animals.
Results and discussion
Test results
- Species / strain:
- other: CHL cells 1-164
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results:
- Number of polyploid cells: 0%
- Number of structural aberrations: 2.0%
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
