Registration Dossier

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Genetic Toxicity Evaluation of alpha-Fenchone (1195-79-5) in Micronucleus Study A52245 in F344 Rats
Author:
NTP
Year:
2018
Bibliographic source:
Chemical effect in biological system, U.S Department of Health and human Services, 2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of Fenchone in F344 male rats by micronucleus assy.
GLP compliance:
not specified
Remarks:
Micronucleus Assay
Type of assay:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: 3,3-Dimethyl-8,9-dinorbornan-2-one
- InChI: 1S/C10H16O/c1-9(2)7-4-5-10(3,6-7)8(9)11/h7H,4-6H2,1-3H3/t7-,10+/m0/s1
- Smiles: C[C@@]12CC[C@@H](C1)C(C)(C)C2 =O
- Name of test material:Fenchone
- Molecular formula:C10H16O
- Molecular weight:152.2354 g/mol
- Substance type:Organic
Specific details on test material used for the study:
- Name of test material :Fenchone
- Common name : 1,3,3-trimethylbicyclo[2.2.1]heptan-2-one
- Molecular formula : C10H16O
- Molecular weight : 152.2354 g/mol
- Smiles notation : C[C@@]12CC[C@@H](C1)C(C)(C)C2=O
- InChl : 1S/C10H16O/c1-9(2)7-4-5-10(3,6-7)8(9)11/h7H,4-6H2,1-3H3/t7-,10+/m0/s1
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Fischer 344
Details on species / strain selection:
Not specified
Sex:
male
Details on test animals and environmental conditions:
Not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Corn oil
Details on exposure:
Not applicable
Duration of treatment / exposure:
72 hours
Frequency of treatment:
3 times in 72 hours
Doses / concentrations
Remarks:
0,156,312,625,1250 and 2500mg/kg
No. of animals per sex per dose:
5 animals per dose
Control animals:
yes, concurrent vehicle
Positive control(s):
Positive controls
Cyclophosphamide
- Route of administration: Intraperitoneal Injection
- Doses / concentrations: 20 mg/kg

Examinations

Tissues and cell types examined:
Erythrocyte was examined
Details of tissue and slide preparation:
Details of tissue and slide preparation

METHOD OF ANALYSIS: Slide Scoring was performed
Evaluation criteria:
An increase in the frequency of micronucleated polychromatic erythrocytes was observed.
Statistics:
Yes Mean MN-PCE/1000 PCE ± SEM and Mean Percent PCE ± SEM were observed

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
ambiguous
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

 

 

Dose mg/Kg

No. of animals

Scored

Mean MN-PCE/1000 PCE ± SEM

Pairwise P

Vehicle control

Corn oil

0

5

0.500±0.160

 

Test substance

α Fenchone

156

5

0.500±0.160

0.500

 

 

312

5

0.200±0.120

0.872

 

 

625

5

0.900±0.190

0.142

 

 

1250

5

0.600±0.190

0.382

 

 

2500

5

1.200±0.680

0.045

Positive control

Cyclophosphamide

 

20

5

11.000±2.720

Value less than 0.0001

Applicant's summary and conclusion

Conclusions:
Fenchone (1195-79-5) was evaluated for its mutagenic potential in F344 male rats by micronucleus assy. The test result was considered to be ambiguous.
Executive summary:

In vivo Gene mutation study of Fenchone was assessed for its possible mutagenic potential. For this Purpose micronucleus assay was performed as per similar to guideline study in F344 male rats. The test material was exposed 3 times in 72 hours by Intraperitoneal Injection at the concentration of 0,156,312,625,1250 and 2500mg/kg. The erythrocyte was examined for micronucleated polychromatic erythrocytes . The test result was compared to positive control Cyclophosphamide. The test result was considered to beambiguous. Therefore Fenchone test result was considered to be ambiguous for this study.