(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2000

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

1997

Reference 3

Reference Type:

other: monograph provided by ECHA

Title:

Endpoint record: Genetic toxicity in vitro

Author:

ECHA

Year:

2010

Bibliographic source:

Document from ECHA

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Method B14 of directive 92/96/EEC

Principles of method if other than guideline:

OECD TG 472 Genetic Toxicology: Escherichia coli,
Reverse Assay was merged with TG 471

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

5945-33-5

EC Number:

611-829-8

Cas Number:

5945-33-5

IUPAC Name:

5945-33-5

Constituent 2

Reference substance name:

-

EC Number:

425-220-8

EC Name:

-

Cas Number:

5945-33-5

Molecular formula:

C39H34O8P2

IUPAC Name:

4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenyl diphenyl phosphate; 4-{2-[4-({[4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenoxy](phenoxy)phosphoryl}oxy)phenyl]propan-2-yl}phenyl diphenyl phosphate

Details on test material:

75 - 95% (typical 88%, verified by UV/visible spectrum, Infrared (IR) spectrum, Nuclear Magnetic Resonance (NMR), and Mass spectrum.)

Method

Target gene:

point mutations

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

10% Sprague Dawley male rat liver S9 fraction (Aroclor 1254-induced) in standard cofactors

Test concentrations with justification for top dose:

0, 50, 150, 500, 1500, 5000 µg/plate

Vehicle / solvent:

acetone

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA98 + S9: 0.5 µg/plate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

TA98 – S9: 0.2 µg/plate

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA100 + S9: 1 µg/plate

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

TA100 – S9: 3 µg/plate

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA1535 +S9: 2 µg/plate

Controls 6

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

TA1535 – S9: 5 µg/plate

Controls 7

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA1537 + S9 2 µg/plate

Controls 8

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA1537 – S9: 80 µg/plate

Controls 9

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

CM891 + S9: 10 µg/plate

Controls 10

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

CM891 – S9: 2 µg/plate

Details on test system and experimental conditions:

Each experiment, in the presence and absence of S9, was repeated once and all concentrations were tested in triplicate.

Evaluation criteria:

no data

Statistics:

no data

Results and discussion

Test results

Test results 1

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:

>5000μg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>5000μg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Cytotoxicity effects were observed in preliminary test and main test, but only above 5000μg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Each experiment, in the presence and absence of S9, was repeated once and all concentrations were tested in triplicate.

Precipitation was observed at and above 500 µg/plate but did not interfere with scoring of revertant colonies.

Under the conditions of the study, the test chemical caused no substantial increases in revertant colony numbers over control counts at any concentration in either the presence or absence of the rat liver microsomal enzymes.

All positive and negative controls responded appropriately.

The BDP was considered to be non-mutagenic under the conditions of the assay.

Applicant's summary and conclusion

Conclusions:

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

The test chemical was considered to be non-mutagenic under the conditions of the assay.

Executive summary:

This study was well conducted and negative effects were observed with and without S9 indicated that the test material did not cause point mutation in bacterial reverse mutation test.