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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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
Reference substance name:
tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
EC Number:
413-210-6
EC Name:
tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
Cas Number:
192662-33-2
Molecular formula:
UVCB substance
IUPAC Name:
chromium(3+) 2-methyltridecan-2-aminium bis(4-{2-[5-(2,2-dimethylpropyl)-3-nitro-2-oxidophenyl]diazen-1-yl}-3-methyl-1-(3-sulfamoylphenyl)-1H-pyrazol-5-olate)
Details on test material:
- Substance type: pigment, powder
- Physical state: solid
- Purity test date: no data
- Lot/batch No.: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997
- Stability under test conditions: yes
- Storage condition of test material: room temperature

Method

Target gene:
his, trp
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9-mix
Test concentrations with justification for top dose:
20 - 5000 µg/0.1 mL in the toxicity test;
312.5 - 5000 µg/0.1 mL in the mutagenicity tests
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Dimethylsulfoxide
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see table 1
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:
The test substance is considered to be positive in this test system if one or both of the following conditions are met:
- at least a reproducible doubling of the mean number of revertants per plate above that of the negative control at any concentration level for one or more of the following strains: TA 98, TA 1535, TA 1537 and E. coli WP2uvrA,
- a reproducible increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 1.5 for strain TA 100.
Generally a concentration-related effect should be demonstrable.
Statistics:
A statistical analysis has not been performed. Statistical methods concerning this particular test system are only used at the limits of the criteria for a positive response.

Results and discussion

Test resultsopen allclose all
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:
not examined
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
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
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