potassium titanium oxide (K2Ti6O13)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Negative, Ames test (TA1535, TA1537, TA98, TA100 and WP2uvrA)

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

Study period:

07 January 1999 to 01 February 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).

Qualifier:

according to guideline

Guideline:

other: Annex V (Ames test)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Target gene:

S. typhimurium: Histidine locus
E. coli: Tryptophan locus

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:

Aroclor induced, rat-liver S9

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 μg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Details on test system and experimental conditions:

Concentration of the test material resulting in precipitation: 5000 μg/plate

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:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
Vehicle control plates gave counts of revertant colonies within the normal range.
All positive control chemicals gave increases in revertants, either with or without the metabolising system as appropriate, within expected ranges. No statistically significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: (preliminary test and main test)

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

Under the conditions of the study, the test material showed no evidence of mutagenic activity in the bacterial system and therefore is considered to be negative for genotoxicity.

Executive summary:

The genotoxicity of the test material was investigated in a study which was conducted under GLP conditions and following the Ames test method.

Four strains of S. typhimurium and one strain of E. coli were treated in the absence and presence of metabolic activation. Under the conditions of the test, no evidence of mutagenic activity in the bacterial system was observed and the test material was determined to be negative for genotoxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The genotoxicity of the test material was investigated in a study which was conducted under GLP conditions and following the Ames test method.

Four strains of S. typhimurium and one strain of E. coli were treated in the absence and presence of metabolic activation. Under the conditions of the test, no evidence of mutagenic activity in the bacterial system was observed and the test material was determined to be negative for genotoxicity.

The study was assigned a reliability score of 1 in accordance with the principles for assessing data quality as set forth in the publication by Klimisch et al (1997).

 

Justification for selection of genetic toxicity endpoint
Only one study is available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to genetic toxicity.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to genetic toxicity.