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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-420-3
EC Name:
-
Molecular formula:
C31H19ClN7Na5O19S6
IUPAC Name:
sodium (E)-2-(4-(4-chloro-6-(7-((1,5-disulfonatonaphthalen-2-yl)diazenyl)-8-hydroxy-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)phenylsulfonyl)ethyl sulfate
Test material form:
solid: particulate/powder

Method

Species / strain
Species / strain / cell type:
other: S.Typhimurium TA98, TA100, TA1535, Ta1538, E. Coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9 mix rat and hamster liver
Test concentrations with justification for top dose:
Concentration range in the first test (with and without metabolic activation): 4, 20, 100, 500, 2500 and 5000 µg/plate
Concentration range in the second test (with and without metabolic activation): 4, 20, 100, 500, 2500 and 5000 µg/plate
Vehicle / solvent:
none
Details on test system and experimental conditions:
method of application: in agar, plate incorporation

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 10000 ug/plate
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 10000 ug/plate
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The substance was tested for genetic toxicity in vitro following OECD 471 (Ames test). Under the experimental conditions the substance did not show any mutagenic properties with and without metabolic activation
Executive summary:

The substance was tested for mutagenicity with the strains TA100, TA1535, TA1537, TA1538, TA98 of salmonella typhimurium and Escherichia coli WP2uvrA.

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different dosees from 4 µg/plate to 5000 µg/plate was used.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.

Toxicity: the test compound proved to be not toxic o f the bacterial strains. On the basis of the preliminary test results the top dose level did no exceed 5000 µg/plate.

Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the test item did no result in relevant increases in the number of revertant colonies.

Sumarizing, it can be stated that Reaktiv-Rot F-52 167 is not mutagenic in these bacterial test systems niether with or without exogenous metabolic activation at the dose levels investigated.