3,3-dimethyl-8,9-dinorbornan-2-one

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:

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

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

Test material information

Constituent 1

Reference substance name:

3,3-dimethyl-8,9-dinorbornan-2-one

EC Number:

214-804-6

EC Name:

3,3-dimethyl-8,9-dinorbornan-2-one

Cas Number:

1195-79-5

Molecular formula:

C10H16O

IUPAC Name:

1,3,3-trimethylbicyclo[2.2.1]heptan-2-one

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 or test system 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.