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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-200-5 | CAS number: 92-88-6
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Only four tester strains were used rather than five as required by test guidelines.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative toxicity of diphenyl, diphenyl ether, and some of their derivatives
- Author:
- Pagano G, Cipollaro m, Corsale G, Del-la Morte R, Esposito A, Giordano GG, Micallo G, Quinto I & Staiano N
- Year:
- 1 988
- Bibliographic source:
- Medecine Biologie Environnement, Vol 16
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The methods used were in accordance with the standard bacterial reverse mutation test described by Ames et al.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Biphenyl-4,4'-diol
- EC Number:
- 202-200-5
- EC Name:
- Biphenyl-4,4'-diol
- Cas Number:
- 92-88-6
- Molecular formula:
- C12H10O2
- IUPAC Name:
- [1,1'-biphenyl]-4,4'-diol
- Details on test material:
- No further details.
Constituent 1
Method
- Target gene:
- Point mutations at GC base pairs
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA100, TA98, TA97 and TA102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Microsomes from PB- or 3-MC induced rat liver and a NADPH-generating system
- Test concentrations with justification for top dose:
- No details are given in the paper relating to test concentrations used in the Salmonella reverse mutation assays. The assays were conducted to compare results with an embryotoxicity assay in S.granularis (sea urchin). The concentrations used in that assay were in the 10-6 to 10-5 range since 10-7 was ineffective and 10-4 proved to be embryotoxic. It is unclear whether the same concentrations were used in the Salmonella assay.
- Vehicle / solvent:
- DMSO, the solvent level was 0.01%
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- The paper indicates the methods of Ames were followed in this assay using pre-incubation and plate incorporation and presumably the relevant positive and negative controls, but no details of either are presented.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation and preincubation replicates but no details were presented in the publication
DURATION
- Preincubation period: no data
- Exposure duration: no data
- Expression time (cells in growth medium): no data
- Selection time (if incubation with a selection agent): no data
- Fixation time (start of exposure up to fixation or harvest of cells): no data
Salmonella mutagenicity assays were conducted according to Ames standard methods including both plate incorporation and liquid incubation. The tester strains were TA100, TA98, TA97 and TA102. Duplicate assays were completed, with and without metabolic activation. The bacteria were routinely checked for their spontaneous reversion rate and for the response to known mutagens.
The salmonella assay was conducted for comparative purposes to determine whether diphenyl and diphenyl ether and their hydroxy derivatives had mutagenesis and embryogenesis effects in prokaryotic and eukaryotic organisms.
No additional details provided for the Salmonella tests. - Evaluation criteria:
- No details provided. The assay was conducted to standard Ames methods and it can be presumed the evaluation was in accordance with Ames standard methods also.
- Statistics:
- No details
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Diphenyl, diphenyl ether and their hydroxy derivatives including 4,4'-dihydroxydiphenyl, gave negative results in all of the reverse mutation assays in all tester strains irrespective of the plate incorporation or liquid incubation methods used, with or without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with or without metabolic activation
Negative results in all tester strains for 4,4'-dihydroxydiphenyl, with or without metabolic activation. - Executive summary:
In a standard Ames test, using only four tester starins, TA100, TA98, TA97 and TA102, negative results were obtained in all tester strains for 4,4'-dihydroxydiphenyl, with or 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.
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.
