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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:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study reasonably documented, according to generally accepted scientific principles. Appears similar to an appropriate OECD guideline, but does not appear to be compliant with GLP.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Mutagenicity of metal salts in combination with 9-amino-acridine in S typhimurium
Author:
Ogawa HI, Tsuruta S, Nuyitani Y, Mino H, Sakata K, Kato, Y
Year:
1987
Bibliographic source:
Jpn. J. Genet. 26: 159-162
Reference Type:
publication
Title:
Combined mutagenicity of cobalt (II) salt and heteroaromatic compounds in Salmonella typhimurium
Author:
Ogawa HI et al
Year:
1986
Bibliographic source:
Mutation Research 172:97-104
Reference Type:
secondary source
Title:
Toxicological profile for titanium tetrachloride
Author:
Research Triangle Institute
Year:
1997
Bibliographic source:
US Dept of health and human services Agency for toxic substances and disease registry

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
No activation, not tested in triplicate, inadequate positive controls
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 98, 100, 102, 1537, 2637
Metabolic activation:
without
Test concentrations with justification for top dose:
1-10,000 µmoles per plate
Vehicle / solvent:
- Solvent used: water
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Migrated to IUCLID6: strains 1537 and 2637 only
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation;

DURATION
- Preincubation period: 30 min

OTHER: The mutation assay was repeated in the presence of 9-aminoacridine

Results and discussion

Test results
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 µmoles per plate
Vehicle controls validity:
valid
Positive controls validity:
other: insufficient positive controls used
Additional information on results:
There was no evidence of mutagenicity when the substance was tested in the presence and absence of 9-aminoacridine.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

There is no evidence that the test substance induces mutations in bacteria under the conditions of the study.