Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.