Dihydrogen bis[P,P-dioctyl diphosphato(2-)-O'',O''''][hydroxyacetato(2-)-O1,O2]titanate(2-), branched and linear

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Bacterial reverse mutation, Ames
- Short description of test conditions: four tester strains ( TA98, TA 100, TA 1537, TA 1538) with and without metbolic activation
- Parameters analysed / observed: Reversion rate was graded (< 20, >100, > 500 revertant colonies)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

1

Reference substance name:

Dihydrogen bis[P,P-dioctyl diphosphato(2-)-O'',O''''][hydroxyacetato(2-)-O1,O2]titanate(2-), branched and linear

EC Number:

271-571-3

EC Name:

Dihydrogen bis[P,P-dioctyl diphosphato(2-)-O'',O''''][hydroxyacetato(2-)-O1,O2]titanate(2-), branched and linear

Cas Number:

68585-64-8

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)[(2-{[({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)(hydroxy)phosphoryl]oxy}-4-oxo-1,3-dioxa-2-titanacyclopentan-2-yl)oxy]phosphinic acid; {[({bis[(2-ethylhexyl)oxy]phosphanyl}oxy)({[({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)(hydroxy)phosphoryl]oxy})[(2-hydroxyacetyl)oxy]titanio]oxy}({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)phosphinic acid

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1537

Species / strain 4

Species / strain / cell type:

other: TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S 9

Test concentrations with justification for top dose:

0.1, 10, 100, 250, 500 µg/plate with and without metabolic activation

Vehicle / solvent:

- Vehicle(s) used: acetone

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

benzo(a)pyrene

other: daunomycin, 3-methylanthrene, 2-aminofluorene

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Table 1: Results Ames test

	EXPERIMENT 1 (Revertant colonies per plate)
	S9-Mix	Without
	Test item	TA98	TA 100	TA 1537	TA 1538
Vehicle control (Acetone)	0.1 mL
Test Substance		< 20	< 20	< 20	< 20
Positive control (sodium azide)			> 500
Positive control (daunomycin)		> 100
Positive control (9-aminoacridine)				> 500
	S9-Mix	With
	Test item	TA98	TA 100	TA 1537	TA 1538
Vehicle control (Acetone)	0.5 mL
Test Substance		< 20	< 20	< 20	< 20
Positive control (benzo(α)pyrene)			> 500		> 500
Positive control (3-methylanthrene)				> 500
Positive control (2-aminofluorene)		> 500			> 500

Applicant's summary and conclusion

Conclusions:

Under the conditions of the conducted test the substance was not mutagenic in any of the four strains (TA 98, TA 100, TA 1537 and TA 1538) tested with and without metabolic activation up to 500 µg/plate.