[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Principles of method if other than guideline:

Diphenyl cresyl phosphate was investigated in the Salmonella / microsome test for point mutagenic effects in doses up to 12500 µg per plate on four Salmonella typhimurium LT2 mutants. These were the histidine auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Not applicable

Molecular formula:

C19 H17 O4 P1

IUPAC Name:

Not applicable

Method

Target gene:

Ames assay: detection of base pair substitutions and frameshift mutations

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Test concentrations with justification for top dose:

12500; 2500; 500; 100; 20 µg DPK per plate

Vehicle / solvent:

Ethanol

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Sodium azide; Nitrofurantoin; 4-nitro-1,2-phenylenediamine; 2-aminoanthracene

Details on test system and experimental conditions:

Ames test

Results and discussion

Test results

Key result

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

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

Summary of the results with diphenylcresylphosphate in the Salmonella/ microsome test

S-9 mix	TA 1535	TA 100	TA 1537	TA98
without	negative	negative	negative	negative
with	negative	negative	negative	negative

The positive controls ( Sodium azide; Nitrofurantoin; 4-nitro-1,2-phenylenediamine; 2-aminoanthracene) increased the mutant counts to well over double those of the negative controls, and so demonstrated the system´s sensivity and the activity of the S-9 mix.

Applicant's summary and conclusion

Conclusions:

Dipehnyl cresyl phosphate was negative in Salmonella typhimurium strains TA 1535, TA 100, TA 1537 and TA 98 with and without metabolic activation.

Executive summary:

DPK was investigated in the Salmonella/ microsome test for point-mutagenic effects in doses up to 12500 µg per plate on four Salmonella typhimurium strains TA 1535, TA 100, TA 1537 and TA 98.

In all doses, the substance had a strain-specific bacteriotoxic effect, so that the tested range could only be used to a limited extent up to 12500 µg per plate for evaluation purposes. Substance precipitation occured from the dose 2500 µg per plate.

No evidence for mutagenic activity for DPK was found.