Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read across from supporting substances (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: evaluation of available data
- Justification for type of information:
- Justification for read-across is attached in Section 13 of IUCLID
Data source
Reference
- Reference Type:
- other: assessment of available data
- Title:
- Unnamed
- Year:
- 2 023
Materials and methods
- Principles of method if other than guideline:
- evaluation of available data
- GLP compliance:
- no
- Type of assay:
- other: different test types evaluated
Test material
- Reference substance name:
- SS01-SS07_ZnDBM
- IUPAC Name:
- SS01-SS07_ZnDBM
Constituent 1
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic
- Executive summary:
The genetic toxicity of the substance has been evaluated considering data from supporting substances (structural analogues or surrogate) using the read-across approach.
ECHA disseminated data of one of the similar substances and experimental data reported in literature on different Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102) performed with and without metabolic activation didn’t show any mutagenic effect.
The same results emerged in several mutagenicity studies performed on other read-across substances.
It is reasonable to expect that the mutagenicity of Zinc, Bis (1,3-Diphenyl-1,3-propanedionate) is related to the mutagenicity of read-across substances. For this reason it can be expected that the substance has no mutagenicity.
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.
