Cyclooctanone

Toxicity to reproduction

Administrative data

Endpoint:

fertility, other

Type of information:

experimental study

Remarks:

publication

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

publication

Title:

Cycloalkanones. 4. Antifertility Activity

Author:

Hall IH, Carlson GL, Abernathey GS, Piantadosi C

Year:

1974

Bibliographic source:

J Med Chem.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

For female mouse fertility screening test, female CF1 mice were weighted and administered 50 mg/kg of the test material daily ip for a total of 28 days. On the tenth day of dosing, the females were exposed to males (two females/male) for the remaining experiment. The males were rotated every fifth day. After 28 days of dosing, females were sacrificed. The number of pregnancies, viable fetuses, dead in uterine and resorptions were recorded.
For male fertility screening test, male CF1 mice were dosed with 10 mg/kg/day according to the methode of Coppola (Coppola, J.A. (1969) An extragonadal antifertility agent. Life Sciences 8, 43-48).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Cyclooctanone

EC Number:

207-940-2

EC Name:

Cyclooctanone

Cas Number:

502-49-8

Molecular formula:

C8H14O

IUPAC Name:

cyclooctanone

Specific details on test material used for the study:

The test material was suspended in 1% carboxymethylcellulose (CMC) and homogenised.

Test animals

Species:

mouse

Strain:

CF-1

Sex:

male/female

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Details on exposure:

50 mg/kg/day test material suspended in 1% carboxymethylcellulose (CMC) administered in 0.2 cc ip.
Doses were adjusted for weight gains during the experiment.

No. of animals per sex per dose:

8 females for fertility screening

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Mortality:

no mortality observed

Body weight and weight changes:

not specified

Reproductive function / performance (P0)

Reproductive performance:

no effects observed

Description (incidence and severity):

female fertility: (percentage of control)
Pregnancies: 88%
Viable fetuses per litter: 109%
Reabsorption per litter: 170%

male fertility:
no effects on male fertility (copulated successfully with fertile females resulted in viable offspring)

Details on results (P0)

A change greater than 25% is considered to be significant concerning female fertility. The average number of fetuses and reabsorption sites for the control including uterine death for CFI mice was 12±3 and 0.48±0.12 per litter, respectively. These values were set equivalent to 100%.

Effect levels (P0)

Remarks on result:

not determinable due to absence of adverse toxic effects

Applicant's summary and conclusion

Conclusions:

Based on fertility screening after intraperitoneal administration for a period of 28 days the NOAEL for cyclooctanone was set at ≥ 50 mg/kg/day in female CF1 mice. Due to no effects in male mouse fertility screen, the NOAEL for cyclooctanone was set at ≥ 10 mg/kg/day in male CF1 mice. Based on the available information, no classification for adverse effects on sexual function and fertility according to CLP Regulation (EC) No. 1272/2008 is required.