Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Read-across was used. Hypothesis for the analogue approach: see files attached under section 13 assessment reports Read Across Justification. Test for source substance to genetic toxicity in vitro was performed according to EU Method B.13/14 and compliant with GLP.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium: TA 98, TA 100, TA102, TA 1535, TA 1537, et E.coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S 9 mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 321.5...5000 µg/plate
Concentration range in the main test (without metabolic activation): 321.5...5000 µg/plate
Vehicle / solvent:
Solvent: acetone

Results and discussion

Test results
Species / strain:
other: as specified above
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Additional information on results:
Observatons: no mutagenic activity
Remarks on result:
other: other: preliminary test
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 Ames-test for test substance indicated negative results with and without metabolic activation. The test substance (source substance) bis(hydrogenated tallow C16-C18-alkyl)hydroxylamine is a structurally very similar substance to target substance hydroxylamines, di-C16-18 (even numbered) alkyl. It can be reasonably assumed that target substance has also negative results with and without metabolic activation.