Octan-2-one

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

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 is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Cycloalkanones. 7.' Hypocholesterolemic Activity of Aliphatic Compounds Related to 2,8-Dibenzylcyclooctanone

Author:

G. L. Carlson, I. H. Hall, and C. Piantadosi

Year:

1975

Bibliographic source:

Journal of Medicinal Chemistry, 1975, Vol. 18, No. 10 pp 1024-1026

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: No data

Principles of method if other than guideline:

To evaluate the Antifertility Activities of test chemical in female CF1 mice.

GLP compliance:

not specified

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

111-13-6

IUPAC Name:

111-13-6

Constituent 2

Reference substance name:

Octan-2-one

EC Number:

203-837-1

EC Name:

Octan-2-one

Cas Number:

111-13-7

Molecular formula:

C8H16O

IUPAC Name:

octan-2-one

Test material form:

liquid

Details on test material:

- Name of test material: Octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.21 g/mol
- Substance type: Organic
- Physical state: Liquid

Specific details on test material used for the study:

- Name of test material: 2-octanone
- IUPAC name: octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.2134 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data available

Test animals

Species:

mouse

Strain:

CD-1

Sex:

female

Details on test animals or test system and environmental conditions:

- Source: Carworth Farms
- Diet (e.g. ad libitum):Purina lab chow, ad libitum
- Water (e.g. ad libitum):water ad libitium

Administration / exposure

Route of administration:

intraperitoneal

Type of inhalation exposure (if applicable):

not specified

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1 %

Details on exposure:

DOSAGE PREPARATION (if unusual): Test compound was suspended in 1% carboxymethylcellulose- H20 (1% CMC) and homogenized

VEHICLE
- Concentration in vehicle:50 mg/kg
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: 1% carboxymethylcellulose- H20 (1% CMC)
- Lot/batch no. (if required):
- Purity:

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

approx 19.4(gestation days) days.

Frequency of treatment:

Daily

Duration of test:

approx 19.4(gestation days) days.

Doses / concentrations

Dose / conc.:

50 mg/kg bw/day

No. of animals per sex per dose:

Total no of animals-78 females
0 mg/kg/day-62 female rats
50 mg/kg/day-8 female rats
Diethyl stilbestrol: -8 female rats

Control animals:

yes, concurrent vehicle

Details on study design:

Diethyl stilbestrol was used as positive control.

Statistics:

Yes, Student's t test and standard deviation were measured

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day

Based on:

test mat.

Sex:

female

Basis for effect level:

body weight and weight gain

clinical signs

other: No effect on Number of reabsorption sites and dead in utero per litter, viable foetuses per litter

Observed effects

No toxic clinical sign and change in body weight were observed in treated female mice at 50 mg/kg as compared to control. In addition, no reproductive effect such as number of reabsorption sites, dead in utero per litter, percent pregnant and number of viable foetuses per litter as compare to control.

Any other information on results incl. tables

Antifertility Activities of Aliphatic Analogs of test chemical in CF1 Mice

 

Sr no	Compound	N	%pregnant	% average no. of foetuses per litter^a	% average no. of reabsorption sites per litter^a
1	Control	62	100	100±25	100±25
2	test chemical	8	75	87	0
3	Diethyl stilbestrol	8	0	0	0

aAverage number of foetuses for CF1 mice = 12 ±3 and average number of reabsorption = 0.48 ± 0.12 per litter.

These values are considered to be 100%.

 

Applicant's summary and conclusion

Conclusions:

NOAEL was considered to be 50 mg/kg bw /day for P and F1 generation when CF-1 female mice were treated with test chemical daily approx 19.4(gestation days) days.

Executive summary:

In an antifertility activity study, CF-1 female mice were treated with test chemical in the concentration of 50 mg/kg in 1% carboxymethylcellulose- H20 (1% CMC) and homogenized and administrated daily by intraperitoneally. No toxic clinical sign and change in body weight were observed in treated female mice at 50 mg/kg as compared to control. In addition, no reproductive effect such as number of reabsorption sites, dead in utero per litter, percent pregnant and number of viable foetuses per litter as compare to control. Therefore, NOAEL was considered to be 50 mg/kg bw /day for P and F1 generation when CF-1 female mice were treated with test chemical daily.