2-amino-4-nitrophenol

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

In vivo Gene toxicity study for test chemical in B6C3F1 male Mouse by IN vivo Mammalian Somatic cell study.

Author:

National Toxicology Program

Year:

2018

Bibliographic source:

NTP, Chemical effects in biological system

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Principles of method if other than guideline:

To evaluate the mutagenic potential of test chemical in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study.

GLP compliance:

not specified

Type of assay:

other: In vivo Mammalian Somatic cell study.

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-4-nitrophenol

EC Number:

202-767-9

EC Name:

2-amino-4-nitrophenol

Cas Number:

99-57-0

Molecular formula:

C6H6N2O3

IUPAC Name:

2-amino-4-nitrophenol

Details on test material:

- Name of test material (as cited in study report): 2-Amino-4-nitrophenol
- Molecular formula (if other than submission substance): C6H6N2O3
- Molecular weight (if other than submission substance): 154.13gm/mole
- Substance type: organic

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male

Details on test animals or test system and environmental conditions:

Not specified

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: Corn oil

Duration of treatment / exposure:

72 hour

Frequency of treatment:

3 times in 72 hours

Doses / concentrations

Remarks:

0,4.687,9.375,18.75,37.5,75,150 and 300 mg/Kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes, concurrent vehicle

Positive control(s):

Positive controls; Cyclophosphamide
- Route of administration: Intraperitoneal Injection
- Doses / concentrations:25 mg/kg

Examinations

Tissues and cell types examined:

Bone Marrow cells were examined.

Evaluation criteria:

An increase in the frequency of micronucleated polychromatic erythrocytes in treated animals is an indication of induced chromosome damage.

Statistics:

Yes SD± Mean was observed.

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic effect were observed

Any other information on results incl. tables

Vehicle Control	Corn Oil	0	5	0.700 ± 0.250
Test Chemical	2-Amino-4-nitrophenol	4.687	5	0.900 ± 0.290	0.309
		9.375	4	1.250 ± 0.320	0.116
		18.75	5	2.100 ± 0.480	0.004
		37.5	5	1.700 ± 0.250	0.021
		75	4	1.750 ± 0.520	0.020
		150	5	1.100 ± 0.240	0.173
		300	2	1.000 ± 0.500	0.284
Positive Control	Cyclophosphamide	25	5	16.200 ± 0.800	Value less than 0.0001

 

 

		Dose (mg/kg)	Number of Animals Scored	Mean Percent PCE ± SEM	Pairwise P
Vehicle Control	Corn Oil	0	5	41.170 ± 2.800
Test Chemical	2-Amino-4-nitrophenol	4.687	5	40.130 ± 2.570
		9.375	4	44.000 ± 1.640
		18.75	5	42.830 ± 3.470
		37.5	5	42.120 ± 2.510
		75	4	44.330 ± 2.950
		150	5	40.200 ± 3.900
		300	2	32.700 ± 8.500
Positive Control	Cyclophosphamide	25	5	43.200 ± 2.660

 

		Dose (mg/kg)	Number of Animals Scored	Mean MN-PCE/1000 PCE ± SEM	Pairwise P
Vehicle Control	Corn Oil	0	5	1.100 ± 0.190
Test Chemical	2-Amino-4-nitrophenol	18.75	5	1.300 ± 0.250	0.342
		37.5	5	1.600 ± 0.190	0.168
		75	5	1.100 ± 0.240	0.500
		150	5	0.700 ± 0.250	0.827
Positive Control	Cyclophosphamide	25	5	13.100 ± 0.830	Value less than 0.0001

 

 

		Dose (mg/kg)	Number of Animals Scored	Mean Percent PCE ± SEM	Pairwise P
Vehicle Control	Corn Oil	0	5	46.200 ± 0.000
Test Chemical	2-Amino-4-nitrophenol	18.75	5	54.840 ± 1.200
		37.5	5	44.600 ± 0.510
		75	5	58.640 ± 1.920
		150	5	57.320 ± 1.330
Positive Control	Cyclophosphamide	25	5	46.960 ± 1.900

Applicant's summary and conclusion

Conclusions:

Test substance was evaluated for its mutagenic potential in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study. The test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes.

Executive summary:

In the study test substance was assessed for its possible mutagenic potential. For this purpose wasIn vivo Mammalian Somatic cell study in B6C3F1 male Mouse. The test substance was administrated by Intraperitoneal Injection by using corn oil as vehicle. The test substance was exposed at the concentration of 0, 4.687, 9.375, 18.75, 37.5,75,150 and 300 mg/Kg for 72 hours. The dose was administrated thrice in 72 hours .The bone marrow cells were stained and observed for chromosome damage. No significant increase in the frequency of micronucleated polychromatic erythrocytes in treated animals was observed. Therefore test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes. Hence the substance cannot be classified as mutant In Vivo.