Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Ames test (OECD 471, BASF SE, 2015): negative
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline- and GLP-conformant study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Type of assay:
bacterial reverse mutation assay
Target gene:
Salmonella: his
E. coli: trp
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:
S9 mix of rat livers treated with phneobarbital and b-naphthoflavone
Test concentrations with justification for top dose:
0, 33, 100, 333, 1000, 3000 and 6000 µg/plate
Vehicle / solvent:
DMSO (due to the insolubility of the test substance in water)
Untreated negative controls:
yes
Remarks:
sterility controls
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
other: 4-nitro-o-phenylenediamine, N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 2-aminoanthracene (with S9 mix)
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:
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 nor precipitates, but tested up to recommended limit concentrations
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'.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

An Ames test was employed to test for mutagenic properties of Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy-. The substance was tested in concentrations of 0, 33, 100, 333, 1000, 3000, and 6000 µg/plate on S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, as well as E. coli WP2 uvr A bacteria. The substance did not cause significant increases of mutant colonies, neither in the presence nor in the absence of metabolic activation. Therefore, Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- is considered not mutagenic in the Ames test.


Justification for selection of genetic toxicity endpoint
GLP- and guideline conformant study with robust study summary

Justification for classification or non-classification

The available data do not fulfill the criteria laid out in Regulation (EC) 1272/2008 (CLP). Therefore, a non-classification of Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- is warranted.