Reaction mass of 2-ethylhexyl diphenyl phosphite and bis(2-ethylhexyl) phenyl phosphite and triphenyl phosphite

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro DNA damage and/or repair study

Remarks:

Type of genotoxicity: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study, using older guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Guideline:

other:

Deviations:

not specified

Principles of method if other than guideline:

Method: Other: Based on Slater et al. (1971) Cancer Res. 31:970-973.

GLP compliance:

yes

Type of assay:

other: DNA repair-suspension assay

Test material

Test material information

Constituent 1

Reference substance name:

Diphenyl isodecyl phosphite

IUPAC Name:

Diphenyl isodecyl phosphite

Test material form:

other: liquid

Details on test material:

Diphenylisodecyl phosphite (CAS# 26544-23-0, Lot #DPDP-001-03240A from Borg Warner Company, Parkersburg, WV)

Method

Species / strain

Species / strain / cell type:

other: Escherichia coli tester strains W3110 (pol A+) and p3478 (pol A-)

Metabolic activation:

with and without

Metabolic activation system:

The S-9 fraction from rat liver was induced with Aroclor 1254 and prepared just prior to use.

Test concentrations with justification for top dose:

0, 0.1, 1, 5, 10, and 50 ug/mL

Controls

Controls 1

Positive controls:

yes

Remarks:

(With activation)

Positive control substance:

other: 2-aminofluorene (200 ug/mL)

Controls 2

Positive controls:

yes

Remarks:

(Without activation)

Positive control substance:

other: N-methyl-N’-nitrosoguanidine (2 ug/mL)

Details on test system and experimental conditions:

METHOD OF APPLICATION: Aqueous agar solution
Samples were run in duplicate, with and without metabolic activation.

Evaluation criteria:

The suspension test is scored as the ratio of the number of pol A- survivors over the number of pol A+ survivors (Survival Index). A test material is considered positive if the Survival Index is less than 0.8 and the differential toxicity exhibits a dose response relationship.

Results and discussion

Test results

Species / strain:

other:

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 50 ug/mL with or without activation

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The survival indices at all doses for the test material were greater than 0.80 with or without metabolic activation (0.87 to 1.35 without metabolic activation; 0.93 to 1.07 with metabolic activation). The survival indices for the positive controls were 0.76 and 0.62 for the groups with and without metabolic activation, respectively. The test material PDDP was therefore concluded to not cause preferential killing of the repair-deficient strain in this assay.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material DPDP was concluded to not be mutagenic in this assay.

Executive summary:

The test material DPDP was concluded to not be mutagenic in this assay.