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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

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

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: amino acid dependent
Metabolic activation:
with and without
Metabolic activation system:
rat liver homogenate
Test concentrations with justification for top dose:
4, 20, 100, 500, 2500 and 5000 μg/plate.
Vehicle / solvent:
DMSO (dimethyl sulfoxide)
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Strains TA 100 and TA 1535

Migrated to IUCLID6: without metabolic activation
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
strain TA 1537

Migrated to IUCLID6: without metabolic activation
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
strain TA 98

Migrated to IUCLID6: without metabolic activation
Positive control substance:
other: 2-Aminotanthracene, withmetabolic activation
Remarks:
all strains
Details on test system and experimental conditions:
Two independent mutagenicity studies were conducted, each in the absence and in the presence of a metabolizing system derived from a rat liver homogenate. For both studies, the compound was dissolved in DMSO, and each bacterial strain was exposed to 6 dose levels. Doses for both studies ranged from 4 to 5000 μg/plate (4 / 20 / 100 / 500 / 2500 / 5000 μg/plate).

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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Summarizing, it can be stated that the technical substance was not mutagenic in this bacterial mutation test either in the absence or in the presence of exogenous metabolic activation.
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