3-aminophenol

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

A preliminary toxicity test was performed to define the dose-levels of m-Aminophenol (A015) to be used for the mutagenicity study. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to five dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.

The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-aminophenol

EC Number:

209-711-2

EC Name:

3-aminophenol

Cas Number:

591-27-5

Molecular formula:

C6H7NO

IUPAC Name:

3-aminophenol

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): m-aminophenol
- Molecular formula (if other than submission substance): C6H7NO
- Molecular weight (if other than submission substance): 109.13
- Substance type: Organic
- Physical state: Solid
- storage conditions: at +4°C, protected from light and under nitrogen gas
- titre: 99.0%
- expiry date: September 2005.

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other:

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

A S9 mix consisting of rat liver post-mitochondrial fraction (S9 enzyme fraction) and the necessary cofactors.

Test concentrations with justification for top dose:

PRELIMINARY TESTS:
0, 10, 100, 500, 1000, 2500 or 5000 μg/plate.

MUTAGENICITY EXPERIMENTS
Experiments without S9 mix:
The selected treatment-levels were:
• 156.3, 312.5, 625, 1250 or 2500 μg/plate, for the TA 98 and TA 1537 strains in the first experiment,
• 625, 1250, 2500, 3750 or 5000 μg/plate, for the TA 1535, TA 100 and TA 102 strains in the first experiment and for all the strains in the second experiment.

Experiments with S9 mix:
The selected treatment-levels were:
• 625, 1250, 2500, 3750 or 5000 μg/plate, for all the strains in both experiments.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: dimethylsulfoxide (DMSO),
- Justification for choice of solvent/vehicle: substance is soluble in the current vehicle

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535 - TA 100

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA 98

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

TA 102

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Anthramine (With S9 mix)

Remarks:

TA 1535 - TA 1537 - TA 98 - TA 100 - TA102

Details on test system and experimental conditions:

No data

Rationale for test conditions:

No data

Evaluation criteria:

No data

Statistics:

No data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

The test item did not induce any noteworthy increase in the number of revertants, in any of the five tester strains (TA 1535, TA 1537, TA 100 and TA 102). A moderate toxicity was noted at dose-levels ≥ 2500 μg/plate in the TA 98 strain, without S9 mix.Under the experimental conditions, the test material m-Aminophenol (A015) (batch No. 220117) showed a slight mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.

Executive summary:

A preliminary toxicity test was performed to define the dose-levels of m-Aminophenol (A015) to be used for the mutagenicity study. The test material was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254.

Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C).

Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to five dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored. Evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.

The test material did not induce any noteworthy increase in the number of revertants, in TA 1535, TA 1537, TA 100 and TA 102. A moderate genotoxicity was noted at dose-levels ≥ 2500 μg/plate in the TA 98 strain, without S9 mix.