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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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 Type:
other: Body responsible for the test

Materials and methods

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

Test material

Constituent 1
Test material form:
solid: particulate/powder
migrated information: powder


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
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
Migrated from field 'Test system'.

Applicant's summary and conclusion

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.