Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline- and GLP-conformant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
EC Number:
810-213-8
Cas Number:
1370461-06-5
Molecular formula:
C4 H3 Al O5
IUPAC Name:
sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
Details on test material:
- Name of test material (as cited in study report): Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy-
- Physical state: white solid
- Analytical purity: 85.8 g/100 g
- Batch No.: 13-0001-2
- Storage condition of test material: at room temperature

Method

Target gene:
Salmonella: his
E. coli: trp
Species / strainopen allclose all
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)
Controls
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)

Results and discussion

Test resultsopen allclose all
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'.

Applicant's summary and conclusion