2-nitrophenol

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: Scientifically acceptable publication, comparable to guideline study with restrictions (only 4 strains were tested, 2-Aminoanthracene was the sole indicator of the efficacy of the S9-mix, no details on results are given in the publication)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Salmonella mutagenicity test results for 250 chemicals

Author:

Haworth S, Lawlor T, Mortelmans K, Speck W, Zeiger E

Year:

1983

Bibliographic source:

Environ Mutagen, 5 (Suppl 1), 3-142

Reference 2

Reference Type:

secondary source

Title:

No information

Author:

Rhone-Poulnec Chimie Courbevoie Cedex

Year:

1983

Bibliographic source:

IUCLID Chemical Data Sheet, edited 2000-02-19

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(only 4 strains were tested, 2-Aminoanthracene was the sole indicator of the efficacy of the S9-mix, no details on results are given in the publication)

Principles of method if other than guideline:

The test substance was tested in 2 independent laboratories: CWR (Case Western Reverse University) and EGG (EG & G Maso Research Institute).

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-nitrophenol

EC Number:

201-857-5

EC Name:

2-nitrophenol

Cas Number:

88-75-5

Molecular formula:

C6H5NO3

IUPAC Name:

2-nitrophenol

Details on test material:

- Name of test material (as cited in study report): 2-Nitrophenol
- Label purity: 15 %
- Lot No.: 0808TE
- Obtained from Aldrich
No further details are given on the test material.

Method

Target gene:

his-operon

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:

S9-Mix (rat & hamster, 1 ml containing 0.1 ml S9, 0.02 ml of 0.04 M MgCl2 & 1.65 M KCl, 0.1 ml of 0.04 M NADP, 0.05 M glucose-6-P, and 1 M NaH2PO4 (pH 7.4), and 0.56 ml distilled water)

Test concentrations with justification for top dose:

At least 5 doses of the test substance were tested. Prior the study the test compound was checked for toxicity to TA 100 up to a conc. of 10 mg/plate both with and without S9-mix. If toxicity was not apparent, 10 mg/plate was tested, otherwise the dose of the test chemical was chosen so that the high dose exhibited some degree of toxicity.
The test concentration was not further specified.

Vehicle / solvent:

no data

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: all strains + S9: 2-Aminoanthracene; - S9: TA 98: 4-Nitro-o-phenylenediamine, TA 100 & TA 1535: sodium azide, TA 1537: 9-aminoacridine

Details on test system and experimental conditions:

The test substance was tested in 2 independent laboratories: CWR (Case Western Reverse University) and EGG (EG & G Maso Research Institute).

METHOD OF APPLICATION: Preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3 plates, 2 independent experiments

DETAILS:
Briefly, 0.5 ml of S9-mix or 0.1 M PO4 buffer was dispensed into an appropiate number of 13 x 100 mm culture tubes maintained at 37 °C in a dry-bath. Then, 0.05 ml of cells and 0.05 ml of solvent or chemical dilution were added to each tube. The mixture was vortexed and allowed to incubate with shaking for 20 min at 37 °C. Following the preincubation period, 2.5 ml (EGG) or 2 ml (CWR) of molten top agar (45 °C) supplemented with 0.5 mM L-histidine and 0.5 mM d-biotin was pipetted into the tubes, which were immidiately vortexed, and their contents poured onto 25 ml of minimal glucose bottom agar in a 15 x 100 mm petri dish. After the overlay solidified, the plates were inverted and incubated at 37 °C for 48 h.

DETERMINATION OF CYTOTOXICITY
Prior to the study the test compound was checked for toxicity to TA 100 up to a conc. of 10 mg/plate both with and without S9-mix. EGG used the viability on complete medium as indication of toxicity, CWR evaluated the reduced number of revertant colonies per plate/and or thinning or absence of the bacterial lawn.

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

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No details on results are given in the publication.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative