Reaction mass of 4-tert-butylphenyl diphenyl phosphate and bis(4-tert-butylphenyl) phenyl phosphate and triphenyl phosphate

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

Study period:

June 2, 1978 - June 22, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted similar to OECD Test Guideline No. 471, no GLP, but acceptable basic data.

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 Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

five classes of Salmonella strains included, and Saccharomyces cerevisae in addition; additional phenotypic characteristics of strains not mentioned; maximum concentration: 10 ul/plate; no replication

Principles of method if other than guideline:

Not relevant

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate

EC Number:

700-990-0

Cas Number:

68937-40-6

Molecular formula:

vary

IUPAC Name:

4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): tertbutylphenyl diphenyl phosphate
- Physical state: liquid
- Sample description: Butylated Arylphosphate - 10141D0404

Method

Target gene:

His-gene: Amino acid histidine, and Trp-gene: amino acid tryptophan

Species / strain

Species / strain 1

Species / strain / cell type:

Saccharomyces cerevisiae

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Remarks:

in report

Species / strain 2

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Remarks:

in report

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 induced by Aroclor 1254

Test concentrations with justification for top dose:

0.01, 0.1, 1.0, 5.0, and 10 ul/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9 mix: S. typhimurium TA1535, TA100 and Saccharomyces cerevisae D4: Ethyl Methane Sulfonate; S. typhimurium TA98 and TA1538: 2-Nitrofluorene; S. typhimurium TA1537: Quinacrine Mustard. +S9 mix: All strains: 2-Anthramine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Selection time (if incubation with a selection agent): S. typhimurium: 48 hours; Saccharomyces cerevisae D4: 3-5 days

SELECTION AGENT (mutation assays): agar containing Histidine or Tryptophan

NUMBER OF REPLICATIONS: only 1 plate per concentration

NUMBER OF CELLS EVALUATED: 10*8

DETERMINATION OF CYTOTOXICITY
- Method: no data

Evaluation criteria:

Strains TA-1535, TA-1537, and TA-1538: if the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
Strains TA-98, TA-100, and D4: if the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the highest increase equal to twice the solvent control value for TA-100 and 2-3 times the solvent control value for strains TA-98 and D4 is considered to be mutagenic. For these strains the dose-response increase should start at approximately the solvent control value.

Statistics:

No data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

not examined

Positive controls validity:

not examined

Test results 6

Species / strain:

Saccharomyces cerevisiae

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

other: There is no known positive control compound that works with Saccharomyces cerevisae D4 in the activation plate assays. Without metabolic activation: valid positive controls.

Test results 7

Species / strain:

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

Positive controls validity:

valid

Additional information on results:

No data

Remarks on result:

other: strain/cell type: D4

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

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

The results of the tests conducted on the compound in the absence and in the presence of a metabolic activation system were all negative. The test compound, S-154 Lot QH-30701 B0-78-82, did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.

Executive summary:

The test compound was examined for mutagenic activity in a series of in vitro microbial assays employing S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100, and Saccharomyces cerevisiae D4. The test was conducted similar to OECD Guideline 471.The compound was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor-1254-induced rats. The compound was tested over a series of concentrations such that there was either quantitative or qualitative evidence of some chemically-induced physiological effect at the highest dose level. This, however, could not be checked. The low dose in all cases was below a concentration that demonstrated any toxic effect. The concentrations used were 0.01, 0.1, 1.0, 5.0, and 10 ul/plate.

The results of the tests conducted on the compound in the absence and in the presence of a metabolic activation system were all negative. The test compound, S-154 Lot QH-30701 B0-78-82, did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.