Phosphonic acid, P-phenyl-, zinc salt (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 October to 03 December 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken to GLP to internationally accepted guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Notification of testing methods relating to the new chemical substances (Notification No. 1121002 of JMHLW, No.2 of JMETI, No. 031121002 of JMOE on November 21,2003).

Deviations:

not specified

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Phenylphosphonic acid, zinc salt

IUPAC Name:

Phenylphosphonic acid, zinc salt

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Phenylphosphonic acid, zinc salt
- Substance type: inorganic
- Physical state: White powder
- Analytical purity: > 99%
- Purity test date:
- Lot/batch No.: 060725
- Stability under test conditions: stable in room temperature
- Storage condition of test material: in room temperature, shield from light

Method

Target gene:

No specific target gene as study is exploring general clastogenicity.

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Negative controls - 0.015, 0.023, 0.035, 0.052 and 0.078 mg/ml
Positive control - 0.001 mg/l

Vehicle / solvent:

- Solvent used: CMC (carboxymethyl cellulose)
- Justification for choice of solvent/vehicle:

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 1%water solution of carboxymethy1cellulose sodium salt

Controls 2

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Controls 3

Positive controls:

yes

Positive control substance:

mitomycin C

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Preincubation period:
- Exposure duration: 6 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):

SELECTION AGENT (mutation assays):

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: 100 per rep

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index

OTHER EXAMINATIONS:
- Determination of polyploidy: microscopic examination.
- Determination of endoreplication: microscopic examination.
- Other:

Evaluation criteria:

The test result was judged by comparing frequency of aberrant cells at each dose levels treated with the test substance in each structural and numerical chromosome aberration with the following evaluation criteria. The test substance was judged positive for c1astogenicity when either 10% or more increase in the frequency of the chromosome aberration cells with dose-relativity or 10% or more increase in the frequency of the chromosome aberration cells with reappearance was observed. The test substance was judged positive for clastogenicity also in case the test results with reappearance were observed when the positive result was inconclusive. The dose to induce aberrant cells in 20% of the analyzed cell (D20;mg/ml) was calculated when the test substance was judged positive for clastogenicity.

Evaluation criteria:

Negative (-) less than 5%
Inconclusive (±) from 5 to less than 10%
Positive (+) 10% or more

Statistics:

None

Results and discussion

Test results

Test results 1

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Test results 2

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Remarks on result:

other: other: 1% carboxymethyl cellulose sodium salt

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

It is concluded that PPA-Zn is clastogenic, under the conditions of this study.