Diallyl phthalate

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diallyl phthalate

EC Number:

205-016-3

EC Name:

Diallyl phthalate

Cas Number:

131-17-9

Molecular formula:

C14H14O4

IUPAC Name:

1,2-bis(prop-2-en-1-yl) benzene-1,2-dicarboxylate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): FMC 495
- Physical state: Viscous Colorless Liquid
- Analytical purity: > 98%
- Lot/batch No.: 1st Sample: MLS-2 ; 27, and 2nd Sample: MLS-B#86-15 T/T6306 MLS-4 ; 38
- Stability: Not completely defined
- Storage Conditions: Refrigerate
- Date Study Started: June 24, 1985
- Date Study Completed: May 1, 1986

Method

Target gene:

Not applicable

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

1st Phase (preliminary test with TA100): 10.0, 33.3, 66.7, 100.0, 333.3, 666.7, 1000.0, 3333.3, 6666.7, and 10000.0 µg/plate with or without S-9 Activation.
2nd Phase with the 1st sample of DAP:
- mutagenicity assay with all five strains: 50, 100, 250, 500, and 1000 µg/plate with or without S9.
- repeat mutagenic assay: 250, 500, 1000, 1500, and 3000 µg/plate without S9.
3rd phase with the 2nd sample of DAP:
- mutagenicity assay: 150, 300, 600, 1500, 3000, and 6000 µg/plate without metabolic activation.
25, 50, 100, 250, 500, and 1000 µg/plate with metabolic activation.

Vehicle / solvent:

Dimethylsulphoxide (DMSO)

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

5 µg/plate Migrated to IUCLID6: TA1535

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

75 µg/plate Migrated to IUCLID6: TA1537

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

5 µg/plate Migrated to IUCLID6: TA1538; TA98

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Anthramine for all strings

Remarks:

4 µg/plate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: ovenight at 37 ± 3 ˚C
- Exposure duration: 48 - 72 h at 37 ± 3 ˚C
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: not applicable

Evaluation criteria:

For the test article to be considered positive, it must cause at least a doubling in the mean number of revertants per plate of at least one strain. This increase in the mean umber of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article. For TA1537 or TA1538 revertants less than three-fold, the response must be reproducible.

Statistics:

For each triplicate plating, an average and standard deviation were calculated.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

The positive response of TA 1535 to DAP exposure was more than 2-fold and repeated in all tests performed for both samples.

Remarks on result:

other: strain/cell type: TA 1535

Applicant's summary and conclusion

Conclusions:

Interpretation of results: positive without metabolic activation For one out of five strains tested

Diallyl phthalate caused a positive response in S. typhimurium strain TA1535.