Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
2023

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

Constituent 1
Reference substance name:
SS01-SS07_ZnDBM
IUPAC Name:
SS01-SS07_ZnDBM

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.