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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Titanium tetrakic(dimethylammonium) is an organometalic compound. It can only be handled in air-free environments. It is a flammable liquid and extremely unstable (see also chapter 1.2 or 13). Within seconds, it reacts violently in contact with moisture or water. The decomposition products are dimethylamine and titanium oxide. Dimethylamine is a highly flammable, water-soluble gas. Aqueous solutions of dimethylamine were tested in an in vitro gene mutation assay. Dimethylamine showed no mutagenic potential, both with and without metabolic activation in a study according to OECD TG 471.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
supplier: Eastman
purity: vendor purity no further information given
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
not applicable
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 fractions of Acrolor 1254-induced male Sprague-Dawley rat livers and male Syrian hamster livers were prepared. The S9 mixes were prepared immediately prior to use and contained 10% S9
Test concentrations with justification for top dose:
first test: 0; 33; 100; 333; 1000; 2000; 3333; 4500 µg/plate
second test: 0; 100; 333; 1000; 2000; 3333; 4000 µg/plate
Vehicle / solvent:
distilled water
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 4-nitro-o-phenylenediamine: without metabolic activation, strain TA98; 2-aminoanthracene: with metabolic activation, all strains tested
Details on test system and experimental conditions:
prior to the main test a toxicity assay was carried out with strain TA 100 to determine the appropriate dose range
seven doses were tested in triplicate, experiment was repeated one week after the initial trial
Evaluation criteria:
A chemical was judged to be mutagenic (+) or weakly mutagenic (+W) if it produce a reproducible, doese related increase in his+ over the corresponding solvent control in replicate trials. A chemical was considered questionable if a reproducible increase in his+revertants did not meet the criteria of either a "+" or"+W" or if only a single doses produced an increase in his+ revertants in repeat trials
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: not mutagenic
Executive summary:

Dimethylamine did not show any mutagenic potential both with and without metabolic activation in an in vitro bacterial gene mutation study according to OECD TG 471.

Endpoint:
in vitro gene mutation study in bacteria
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
Titanium tetrakic(dimethylammonium) is an organometalic compound. It can only be handled air-free. It is a flammable liquid and very unstable (see also chapter 1.2 or 13). Within seconds it reacts violently in contact with moisture or water. The decomposition products are dimethylamine and titanium oxide. Dimethylamine is a highly flammable gas but water soluble. Aqueous solutions of dimethylamine were tested for in vitro gene mutation.

Additional information

Justification for classification or non-classification