Phthalonitrile

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: Comparable to guideline with acceptable restrictions (missing E. coli/ TA102 strain)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

missing strain to detect crosslinking/ oxidizing agents

Principles of method if other than guideline:

According to Ames, B.N. et al.: Mutation Research 31, 347-364

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Phthalonitrile

EC Number:

202-044-8

EC Name:

Phthalonitrile

Cas Number:

91-15-6

Molecular formula:

C8H4N2

IUPAC Name:

benzene-1,2-dicarbonitrile

Details on test material:

- Name of test material (as cited in study report): phthalonitrile
- Analytical purity: purity of the substance is not documented

Method

Target gene:

nis-

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9 mix

Test concentrations with justification for top dose:

3.15, 10, 31.5, 100, 315, 1000 and 3000 µg/plate (with S-9 mix); 10, 31.5, 100, 315, 1000 and 3000 µg/plate (without S-9 mix)

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

Positive controls:

yes

Positive control substance:

other: see freetext

Details on test system and experimental conditions:

Standard plate test
Test tubes containing 2 mL soft agar kept in a water bath at 45°C, and remaining
components added in the following order:
0 .1 mL test solution or vehicle
0 .1 mL bacterial suspension
0 .5 mL S-9 mix (in tests with metabolic activation) or 0 .5 ml KCl (in tests
without metabolic activation).
After mixing, the samples are poured onto Vogel-Bonner agar plates.
Where indicated the epoxide hydratase inhibitor and glutathione depletor 1, 1, 1 -trichloropropene 2,3-oxide (TCPO) was added together with the top agar (0.6/µL per plate) .
Two test plates per dose and controls were used; after incubation at 37°C for
48-72hours in the dark, the bacterial colonies ( his+ revertants) are counted.
Positive control:
with metabolic activation: 10 μg/plate Benzo(a)pryene, 10 μg/plate 2-aminoanthracene and 90 μg/plate 3-Methylcholanthrene for each strain;
without metabolic activation: 1 μg/plate Benzo(a)pryene-4,5-oxide and 3.15 μg/plate N-MethyI-N'-nitro-N-nitrosoguanidine, all substances were dissolved in DMSO for all strains.

Results and discussion

Test results

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:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

At the two highest concentrations the test compound partly precipitated on the plate .

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537

Any other information on results incl. tables

Standard plate test (3.15 - 3000 µg/plate)
Strain	Metabolic activation system	Replicates	maximum revertant factor	dose dependency	Assessment
TA 98	no	2	1.2	no	negative
	yes	2	1.1	no	negative
TA 98	not performed
with TCPO	yes	2	1.1	no	negative
TA 100	no	2	1.0	no	negative
Trial 1	yes	2	1.0	no	negative
TA 100	not performed
Trial 2	yes	2	1.0	no	negative
TA 1535	no	2	1.3	no	negative
	yes	2	1.3	no	negative
TA 1537	no	2	1.1	no	negative
	yes	2	1.2	no	negative