2-amino-4,6-dinitrophenol

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

secondary source

Title:

OPINION ON Picramic acid and sodium picramate COLIPA n° B28

Author:

Scientific Committee on Consumer Safety

Year:

2012

Bibliographic source:

Scientific Committee on Consumer Safety, (SCCS) 18 September 2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

2 Amino -4,6 Dinitrophenol

IUPAC Name:

2 Amino -4,6 Dinitrophenol

Constituent 2

Reference substance name:

2-amino-4,6-dinitrophenol

EC Number:

202-544-6

EC Name:

2-amino-4,6-dinitrophenol

Cas Number:

96-91-3

Molecular formula:

C6H5N3O5

IUPAC Name:

2-amino-4,6-dinitrophenol

Test material form:

other: Dark red needles

Details on test material:

- Name of test material (as cited in study report):2 Amino -4,6 Dinitrophenol
- Molecular formula (if other than submission substance): C6H5N3O5
- Molecular weight (if other than submission substance): 199.125g\mol
- Substance type: Organic
- Physical state: Dark red needles.
- Purity : > 99%
- Impurities (identity and concentrations): No data available.

Test animals

Species:

mouse

Strain:

other: Crl:NMRI BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

2% Carboxymethylcellulose

Duration of treatment / exposure:

24 hour for Test group
48 hour for negative control group

Frequency of treatment:

Single dose

Post exposure period:

No data available

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 50 mg/kg bw
Basis:
no data

No. of animals per sex per dose:

0 mg/kgbw-5 male and 5 female (Negative control group)
50 mg /kg bw -5 male and 5 female (Treated group)
40 mg/kg bw-5 male and 5 female (positive control group)

Control animals:

yes, concurrent vehicle

Positive control(s):

Positive control group was treated with cyclophosphamide at a dose of 40 mg/kg bw

Examinations

Tissues and cell types examined:

Bone marrow

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: Based on data from data of a preliminary toxicity assay the test article was administered

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):

DETAILS OF SLIDE PREPARATION: No data available.

METHOD OF ANALYSIS: No data available.

OTHER: No data available

Evaluation criteria:

Increase in the number of polychromatic erythrocytes with micronucleus indicates that the substance was mutagenic

Statistics:

No data available

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay):
- Induction of micronuclei (for Micronucleus assay): No, the test substance did not induce any significant increase in the frequency of micronuclei in the spolychromatic erythrocytes.
- Ratio of PCE/NCE (for Micronucleus assay): No data available.
- Appropriateness of dose levels and route: No data available.
- Statistical evaluation: No data available.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Picramic acid did not induce an increase in the number of polychromatic erythrocytes with micronuclei in treated mice and, consequently, was not genotoxic in bone marrow cells of mice. The result was found to be negative.

Executive summary:

In vivo genotoxicity study for Picramic acid in male and female Crl: NMRIBR mice by In vivo Mammalian Erythrocytes Micronucleus Test were found to be negative.

An increase in the number of normochromatic erythrocytes and decrease in the number of polychromatic erythrocytes respectively could not be observed in the treated groups. This indicates that Picramic acid exerted no toxic influence in the bone marrow. A single oral administration of picramic acid at a dose of 50 mg/kg bw to male and female mice did not produce a significant increase in the frequency of micronuclei in the polychromatic erythrocytes.

According to historical data from NMRI mice, the mean values of all parameters measured were within the respective normal range. The positive control group, treated with cyclophosphamide, revealed a significant increase in the number of micronucleated polychromatic erythrocytes. Picramic acid did not induce an increase in the number of polychromatic erythrocytes with micronuclei in treated mice and, consequently, was not mutagenic in bone marrow cells of mice.