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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
30 April 2013 to 8 May 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Reaction mass of disodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-(vinylsulfonyl)benzenesulfonate and trisodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate
IUPAC Name:
Reaction mass of disodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-(vinylsulfonyl)benzenesulfonate and trisodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 97a, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 hamster liver and/or rat liver
Test concentrations with justification for top dose:
1. experiment: 4999, 1500, 500, 150, 50 microg/plate
2. experiment: 4999, 2500, 1250, 626, 313 microg/plate
Vehicle / solvent:
deionized water
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
congo red
other: 4-Nitro-1,2-phenylene diamine; 2-Amino-anthracene

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97a, TA 98, TA100, TA102, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle 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 with metabolic activation
negative without metabolic activation

The test item is considered as not mutagenic.