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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test based in official method OCDE 471 , and performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
The purpose of this study was to evaluate if the test material would induce a mutagenic response in four different strains of Salmonella (TA98,TA100, TA1335 and TA 1537 ) and E-coli WP2.
The test involves the analysis of the number of revertant colonies that are obtained with each strain in the presence or absence of the test material. Since mutagenic response could vary with the concentration , test material is dosed over an appropriate concentration range (5). Complete set of possitive and negative controls have been included with each assay.
Testing was done with solvent control
All dose levesls of the test material , solvent control and positive controls were plated in triplicate. (Refer to Protocol M09-0093 included in this dossier for the detailed test procedure)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Suga®Nate 160
IUPAC Name:
Suga®Nate 160
Details on test material:
Test material is completely solube in acetone, storage at room temperature , lot number 20756108

Method

Target gene:
(Refer to Protocol M09-0093 included in this dossier for the detailed test procedure)
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 activation
Test concentrations with justification for top dose:
5.0,1.0,0.5,0.1 and 0.05 micrograme /plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-aminoantraceno (all strains +s9)
Remarks:
See información about material and methods

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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