Hydrogen tetrakis[2,2-bis[(allyloxy)methyl]butan-1-olato-O1]bis(ditridecyl phosphito -O'')titanate(2-)

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no detailed information, no strain with AT base pair at the primary reversion site, only tested up to 500 µg/mL, only one experiment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted 21 Jul 1997

Deviations:

yes

Remarks:

only limited information on test substance identity, method and results; no E. coli strain or TA102 tested; only tested up to 500 µg/mL; no individual plate counts; no mean number of revertant colonies per plate; one experiment only

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen tetrakis[2,2-bis[(allyloxy)methyl]butan-1-olato-O1]bis(ditridecyl phosphito -O'')titanate(2-)

EC Number:

264-709-9

EC Name:

Hydrogen tetrakis[2,2-bis[(allyloxy)methyl]butan-1-olato-O1]bis(ditridecyl phosphito -O'')titanate(2-)

Cas Number:

64157-14-8

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

dihydrogen 2-{[(di{[bis(tridecyloxy)phosphanyl]oxido}tris({2,2-bis[(prop-2-en-1-yloxy)methyl]butyl}oxido)titaniotetrakis(ylium))oxido]methyl}-1-(prop-2-en-1-yloxy)-2-[(prop-2-en-1-yloxy)methyl]butane

Method

Target gene:

his operon (for S. typhimurium strains)

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 1538

Metabolic activation:

with and without

Metabolic activation system:

co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats

Test concentrations with justification for top dose:

0.2, 2.0, 20, 200 and 500 µg/plate with and without metabolic activation

Vehicle / solvent:

- Vehicle used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

benzo(a)pyrene

other: daunomycin (-S9) for TA 98 and TA 1538, ß-napthylamine (+S9) for TA 1535, 3-methylanthrene (+S9) for TA1537

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Table 1: Results of the Ames test

	TA98	TA100	TA1535	TA1537	TA1538
Genotype validation	FSM	BPM	BPM	FSM	FSM
Histidine	x	x	x	x	x
Crystal violett sensitivity	x	x	x	x	x
Ampicillin sensitivity	x	x	/	/	/
U.V. sensitivity	x	x	x	x	x
Spontaneous reversion rate	37	159	17	9	19
Positive controls
Sodium azide		+++	+++
Daunomycin	++				++
9-Amino acridine				+++
Positive controls + S9
Benzo(a)pyrene	+++	+++			+++
ß-Naphylamine			++
3-Methylanthrene				+++
2-Aminofluorene
Solvent control 0.1 mL DMSO	x	x	x	x	x
S9 control 0.5 mL S9 mix	x	x	x	x	x
Test item -S9	-	-	-	-	-
Test item +S9	-	-	-	-	-
FSM: Frame shift mutagen, BPM: Base pair mutagen, - = < 20 revertant colonies, ++ = > 100 revertant colonies, +++ = > 500 revertant colonies

Applicant's summary and conclusion

Conclusions:

Under the tested conditions, the test compound was not mutagenic in any of the five tested Salmonella typhimurium strains (TA 98, TA 100, TA 1535, TA1537 and TA 1538) with and without metabolic activation up to 500 µg/plate.