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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer-reviewed, non-GLP study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Test concentration was not accurately determined.
GLP compliance:
no
Remarks:
pre-GLP research project
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium sulphamidate
EC Number:
231-871-7
EC Name:
Ammonium sulphamidate
Cas Number:
7773-06-0
Molecular formula:
H3NO3S.H3N
IUPAC Name:
ammonium sulfamate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
90 to 99% pure

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, TA1535, TA1537, TA1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
not applicable
Test concentrations with justification for top dose:
A small crystal of a substance (approximately 1 to 5 µl of asubstance in solution)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
other: diethyl sulfate

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, TA1535, TA1537, TA1538
Metabolic activation:
not applicable
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
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

Under conditions of this in vitro test, ammonium sulfamte was not demonstrated to be mutagenic.