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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 617-191-7 | CAS number: 81060-07-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.11.2002 - 02.04.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study followed the procedures indicated by the following internationally accepted guidelines and recommendations: "Ninth Addendum to OECD Guidelines for Testing of Chemicals", Section 4, No. 471: "Bacterial Reverse Mutation Test", adopted July 21 , 1997. "Commission Directive 2000/32/EC, L 1362000, Annexe 4D", dated May 19, 2000.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: "Commission Directive 2000/32/EC, L 1362000, Annexe 4D", dated May 19, 2000
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline hydrobromide
- EC Number:
- 617-191-7
- Cas Number:
- 81060-07-3
- Molecular formula:
- C14H20Br2N2 x HBr
- IUPAC Name:
- 2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline hydrobromide
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Bromhexine Hydrobromide
- Physical state: white solid
- Lot/batch No.: 02070864
- Expiration date of the lot/batch: June 2003
- Storage condition of test material: room temperature, aired rooms
- Other:
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment I and II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment III: 3; 10; 33; 100; 333; and 1000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Evaluation criteria:
- The colonies were counted using the AUTOCOUNT (Artek Systems Corporation, BIOSYS
GmbH, D-61184 Karben). The counter was connected to an IBM AT compatible PC with
printer which printed out both, the individual and mean values of the plates for each
concentration together with standard deviations and enhancement factors as compared to
the spontaneaus reversion rates. Due to precipitation and irregular
background growth, the colanies were partly counted manually.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 333 - 5000µg/plate without S9 mix, 1000 - 5000 with S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 333 - 5000µg/plate without S9 mix, 1000 - 5000 with S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
ln conclusion, it can be stated that during the described mutagenicity test and under the
experimental conditions reported, the test item did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used.
Therefore, Bromhexine Hydrobromide is considered to be non-mutagenic in this
Salmonella typhimurium reverse mutation assay.
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.
