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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
in vitro genetic toxicity: negative in vivo genetic toxicity: not performed
Link to relevant study records
in vitro gene mutation study in mammalian cells
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 2010 - Feb 2011
1 (reliable without restriction)
according to guideline
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
Type of assay:
mammalian cell gene mutation assay
Target gene:
HPRT (hypoxanthine-guanine phosphoribosyl transferase)
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Test concentrations with justification for top dose:
The concentrations evaluated (in bold) in the different experiments were:
4-hour first experiment:
without S9-mix: 100p, 50p, 25p, 12.5p, 6.25, 3.13, 1.56, 0.78, 0.39 and
0.2 μg/mL.
with S9-mix: 100p, 50p, 25, 12.5, 6.25, 3.13, 1.56, 0.78, 0.39 and
0.2 μg/mL.
6-hour second experiment:
without S9-mix: 25p, 12.5p, 6.25, 3.13, 1.56, 0.78, 0.39 and 0.2 μg/mL.
with S9-mix: 50p, 25p, 12.5, 6.25, 3.13, 1.56, 0.78 and 0.39 μg/mL.
p precipitation
In all cases, the highest concentration in the culture medium did not change the osmolality of
more than 50 mOsm/kg and did not change the pH value of more than 1.0 unit compared to the
concurrent negative control
Untreated negative controls:
Negative solvent / vehicle controls:
True negative controls:
Positive controls:
Positive control substance:
other: Ethyl methanesulfonate (-S9); 7,12-dimethylbenz[a]anthracene (+S9)
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
other: not mutagen
Cytotoxicity / choice of top concentrations:
other: not mutagen
Vehicle controls validity:
Untreated negative controls validity:
Positive controls validity:
Remarks on result:
other: all strains/cell types tested
Migrated from field 'Test system'.

The purpose of this study was to evaluate the potential of TIB KAT 223 to induce forward mutation at the HPRT (hypoxanthine-guanine phosphoribosyl transferase) locus in V79 Chinese Hamster lung cells with and without metabolic activation by liver homogenate (supplemented with cofactors and salts, ie, S9-mix) obtained from rats pretreated with Aroclor. TIB KAT 223 was suspended and diluted in cell culture medium. Depending on the experiment, cells were exposed to TIB KAT 223 for 4 or 6 hours with and without S9-mix. At the end of the exposure period the cloning efficiency was evaluated in microtiter plates. After a phenotypic expression period of 3 to 4 days, cells were cloned for 7 days in 75 cm2 flasks containing the selection agent 6-thioguanine (TG) for the determination of mutant frequency and in nonselective medium to measure the cloning efficiency. In addition, the number of the mutant colonies was determined. In a solubility pre-test concentrations from 0.01 to 5 mg/mL were investigated using the unaided eye for solubility, homogeneity and precipitation evaluation of the test compound in cell culture medium. In this pre-test all concentrations (except 0.01 mg/mL) were found to be suspensions. However, at 0.1 mg/mL (100 μg/mL) we observed a homogenous distribution of the particles. Therefore, 100 μg/mL was chosen as top treatment concentration in accordance to the OECD 476 Guidline. The highest evaluated concentrations were limited by test article precipitation observed at 12.5 μg/mL and above without S9 mix and 50 μg/mL (Exp. 1) respectively 25 μg/mL (Exp. 2) and above with S9 mix.

Interpretation of results (migrated information):

In conclusion, under the experimental conditions of the study, TIB KAT 223 was found negative
in the mutation assay with V79 Chinese Hamster cells at the HPRT (hypoxanthine-guanine
phosphoribosyl transferase) locus in the presence or absence of metabolic activation up to
concentrations exhibiting test article precipitation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The three performed in vitro genetic toxicity tests (OECD 471, 473, 476) show no evidence of genetic toxicity. In due to the results form the in vitro testing and according Annex IIX of the regulation 1907/2006/EC no in vivo testing is required.

Additional an in-vivo study for the hydrolysis product Dioctlytin oxid is citeted, the outcome of this study is negative, too.

Justification for classification or non-classification

OECD Guideline 471 (Bacterial Reverse Mutation Assay): negative

OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test): negative

OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test): negative

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)