Registration Dossier
Registration Dossier
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EC number: 204-435-9 | CAS number: 120-92-3
Developmental toxicity / teratogenicity
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: The test substance purity was unknown. The study was only described in an abstract without details. The protocol was similar to the standard method of the guidelines even if only two doses were used.
Data source
Reference
- Reference Type:
- publication
- Title:
- A teratology screening study in rats with cyclopentanone
- Author:
- Rusch GM, Rodwell DE, Nemec MD, Tasker EJ
- Year:
- 1 988
- Bibliographic source:
- The Toxicologist, 8, 213
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A teratology screening study in rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Cyclopentanone
- EC Number:
- 204-435-9
- EC Name:
- Cyclopentanone
- Cas Number:
- 120-92-3
- Molecular formula:
- C5H8O
- IUPAC Name:
- cyclopentanone
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- - Vehicle:
Amount of vehicle: 5 mL/kg
No more data - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- From days 6 through 15 of gestation
- Frequency of treatment:
- Once daily
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 25 females per dose.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
Examinations
- Maternal examinations:
- Appearance and behaviour were evaluated and body weights were recorded.
No more data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
A gestation day 20 Cesarean section was performed to evaluate intrauterine survival and fetal development indices including fetal body weights and external, skeletal and visceral morphology. - Fetal examinations:
- - External examinations: Yes: no other information available
- Soft tissue examinations: Yes: no other information available
- Skeletal examinations: Yes: no other information available
- Head examinations: No data - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No maternal, embryotoxic or teratologic effects were expressed at either dose level.
However, the highest dose was selected to produce maternal toxicity expressed as reduced body weight gain in a range-finding study
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 300 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The only potential compound-related effect in the study was a slightly decreased mean fetal body weight at the 300 mg/kg bw dose although this value was within the range of the WIL historical data.
An increase in the number of litters with fetal variant malaligned sternebrae occurred at the 50 mg/kg bw dose, but the incidence at the highest dose was comparable to the control group: the 50 mg/kg bw/day dose level was considered as "no-effect" level.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 300 mg/kg bw/day
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- One developmental study was conducted with cyclopentanone administrated in rats by gavage from days 6 through 15 of gestation at 50 or 300 mg/kg bw. No developmental effects were observed.
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