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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data from 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: as per mentioned below
Principles of method if other than guideline:
The developmental toxicity test has been conducted on chemical 2-octanone,exposed to male CF1 mice intraperitonialy daily with dose concentration of 50mg/kg/day.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Octan-2-one
EC Number:
203-837-1
EC Name:
Octan-2-one
Cas Number:
111-13-7
IUPAC Name:
octan-2-one
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

Test animals

Species:
mouse
Strain:
CF-1
Details on test animals or test system and environmental conditions:
Details on test animal & Environmental conditions

TEST ANIMALS
- Source: Carworth Farms
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): Purina lab chow
- Water (e.g. ad libitum): ad libitum - Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
other: Intraperitonial
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: carboxymethylcellulose- H20(CMC)
Details on exposure:
Details on exposure

PREPARATION OF DOSING SOLUTIONS:
Test compound was suspended in 1% carboxymethylcellulose- H20 (1% CMC) and homogenized. Doses (mg/kg) were calculated on daily weights of the mice


VEHICLE
- Justification for use and choice of vehicle (if other than water):No data available
- Concentration in vehicle:50 mg/kg/day
- Amount of vehicle (if gavage):1%
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data available
Details on mating procedure:
No data available
Duration of treatment / exposure:
No data available
Frequency of treatment:
Daily
Duration of test:
19.4 days- average gestation time
No. of animals per sex per dose:
No data available
Control animals:
yes
Details on study design:
Control animals were given 1% CMC only

Examinations

Maternal examinations:
Antifertility activity
Ovaries and uterine content:
No data available
Fetal examinations:
Yes,Average number of fetuses per litter
Statistics:
the number of animals in a group, expressed as N, the mean of the percent of control, and standard deviation, expressed as i f S.D.,ar e noted. The probable
significant level ( p ) was determined by the Student's t test according to the procedure of Snedecor.
Indices:
No data available
Historical control data:
No data available

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects. Remark: no antifertility was observed at an effective dose level.

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes. Remark: Average no. of fetuses per litter – no significant change was observed as compared to control.

Effect levels (fetuses)

Key result
Remarks on result:
not measured/tested

Fetal abnormalities

Key result
Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The no observed adverse effect level was found to be 50 mg/kg/day when exposed to female mice intraperitonially by chemical 2-octanone daily for 19.4(gestation days) days.
Executive summary:

The developmental toxicity test has been conducted on chemical 2-octanone,exposed to male CF1 mice intraperitonialy daily with dose concentration of 50mg/kg/day.the number of viable fetuses per litter was observed in the test.No significant change was observed as compared to control.Hence, The no observed adverse effect level was found to be 50 mg/kg/day when exposed to female mice intraperitonially by chemical 2-octanone daily for 19.4(gestation days) days..