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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study, only basic data available from SNIF (ECHA)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Based on OECD Guideline for the Testing of Chemicals No. 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
610-025-4
EC Number:
610-025-4
IUPAC Name:
610-025-4
Constituent 2
Chemical structure
Reference substance name:
Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
EC Number:
403-360-0
EC Name:
Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
Cas Number:
42405-40-3
Molecular formula:
C30H42O6Zn
IUPAC Name:
bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation system:
Arochlor induced, rat-liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 15 ... 5000 ug/pIate
Concentration range in the main test (without metabolic activation): 15... 5000 ug/plate
Vehicle / solvent:
Solvent: dimethylsulfoxide

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 ug/plate
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 ug/plate
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 ug/plate
Additional information on results:
Observations:

Solvent control plates gave counts of revertant colonies within the normal range. All positive control chemicals gave increases in revertants, either with or without the metabolising system as appropriate, within expected ranges. No statistically significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance, either with or without metabolic activation. The substance was found to be non-mutagenic under the conditions of the test.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The standard S9 used is considered an adequate metabolic activation system for this substance.

The substance was tested up to the toxic limit, and hence, exposure is adequate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation