Ethyl diphenylphosphinite

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented guideline study, no e.coli strain tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethoxydiphenylphospin

IUPAC Name:

Ethoxydiphenylphospin

Details on test material:

- Name of test material (as cited in study report): Ethoxydiphenylphosphin
- Physical state: yellowish liquid
- Analytical purity: 94.2%
- Lot/batch No.: 89 0011
- Storage condition of test material: room temperature

Method

Target gene:

his

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

The Salmonella strains are checked for the following characteristics at regular intervals:
deep rough character, UV sensitivity, ampicillin resistance.
Histidine auxotrophy is automatically checked in each experiment via the spontaneous rate.

Metabolic activation:

with and without

Metabolic activation system:

aroclor 1254 induced rat liver S9

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500, 5000µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N-nitro-N-nitroso-guanidine (for TA100, TA1535), 4-nitro-o-phenylendiamine (for TA98), 9-aminoacridine chloride monohydrate (for TA1537)

Remarks:

without S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in suspension

DURATION
- Preincubation period: 20 min (in the pre-incubation experiment, otherwise poured directly onto agar plates)
- Exposure duration: 48h

SELECTION AGENT (mutation assays): minimal amino acid solution (0.5mM histidine, 0.5mM biotin)

NUMBER OF REPLICATIONS: 3 test plates per dose


DETERMINATION OF CYTOTOXICITY
- Method:cloning efficiency in the two highest dosage with S9

Evaluation criteria:

In general, a substance has to fulfull the following requirements to be considered positive in the Ames test:
- doubling of the spontaneous mutation rate (compared to control)
- dose-response relationship
- reproducibility of the results.

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:

other: weak bacteriotoxicity in TA100 >= 2500µg/plate with and without S9

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

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:

at 5000µg/plate with and without S9 in TA100 and with S9 in TA1535, TA98, TA1537

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: other: standard plate test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

The test substance is not mutagenic in the Ames test under the experimental conditions chosen here.

Executive summary:

The substance was tested for mutagenicity in the Ames test (standard plate test and preincubation test) both in the presence and in the absence of rat liver S-9 mix using the strains TA 1535, TA 100, TA 1537 and TA 98.

An increase in the number of his revertants was not observed both in the standard plate test and in the preincubation test either with or without S-9 mix.