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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Comparable to guideline study with acceptable restrictions (missing tester strain to detect crosslinking/oxidising agents, non-GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
missing tester strain to detect crosslinking/oxidising agents
Principles of method if other than guideline:
Standard plate test (repeated with identical concentrations)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese antimony titanium buff rutile
EC Number:
270-185-2
EC Name:
Manganese antimony titanium buff rutile
Cas Number:
68412-38-4
Molecular formula:
(Ti, Sb, Mn) O2
IUPAC Name:
manganese antimony titanium buff rutile
Details on test material:
- Storage condition of test material: 4°C

Method

Target gene:
his-
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
induced rat liver S-9 mix
Test concentrations with justification for top dose:
0, 20, 100, 500, 2500 and 5000 ug/ plate
Vehicle / solvent:
DMSO
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: with S-9 mix: 10 ug 2-aminoanthracene (all strains); without S-9 mix: 5 ug N-methyl-N'-nitro-N-nitroso-guanidine for strains TA100 & TA1535; 10 ug 4-nitro-o-phenylenediamine for strain TA98; 100 ug 9-aminoacridine chloride monohydrate for strain TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


NUMBER OF REPLICATIONS: 3
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results
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
Positive controls validity:
valid
Additional information on results:
Complete solubility of the test substance in DMSO.

Any other information on results incl. tables

1st Standard Plate Test
Solvent: DMSO
Strain Metabolic activation system Replicates maximum revertant factor dose dependency Assessment
TA 1535 no 3 1.2 yes negative
yes 3 1.3 no negative
TA 100 no 3 1.1 no negative
yes 3 1.1 no negative
TA 1537 no 3 1.3 no negative
yes 3 1.4 no negative
TA 98 no 3 1.1 no negative
yes 3 1.0 no negative
2nd Standard Plate Test
Solvent: DMSO
Strain Metabolic activation system Replicates maximum revertant factor  dose dependency Assessment
TA 1535 no 3 1.0 no negative
yes 3 1.3 no negative
TA 100 no 3 1.1 no negative
yes 3 1.0 no negative
TA 1537 no 3 0.9 no negative
yes 3 1.1 no negative
TA 98 no 3 1.1 no negative
yes 3 1.1 no negative

Applicant's summary and conclusion