Registration Dossier
Registration Dossier
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EC number: 203-845-5 | CAS number: 111-20-6
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- details to the methods and tables with raw data are missing
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of disodium sebacate
- Author:
- Greco A.V., Mingrone G., Mastrimattei A. E., Finotti E., Castagneto M.
- Year:
- 1 990
- Bibliographic source:
- DRUGS EXPTL. CLIN. RES. XVI (10) 531-536
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium sebacate
- EC Number:
- 241-300-3
- EC Name:
- Disodium sebacate
- Cas Number:
- 17265-14-4
- Molecular formula:
- C10H18O4.2Na
- IUPAC Name:
- disodium sebacate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Housing: separate
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: pellet diet
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with: pellet diet
VEHICLE
- Concentration in vehicle: - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- ♂/♀ ratio per cage: 1/20
- Length of cohabitation: 10 days - Duration of treatment / exposure:
- Group 1: 10 animals: day 1 to 25 of pregnancy,
Group 2: 10 animals: day 1 to 25 of pregnancy plus 3 months including suckling period - Frequency of treatment:
- continuously
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- given via the diet
- No. of animals per sex per dose:
- 10 females per group
- Control animals:
- yes
Examinations
- Maternal examinations:
- POST-MORTEM EXAMINATIONS: Yes
- Organs examined: Uterus, ovaries, placenta - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination
- Fetal examinations:
- - External examinations: Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Gross pathological findings:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Both macroscopic and microscopic features of the uterus, placenta and ovaries appeared normal.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: no (adverse) effects observed
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Reduction in number of live offspring:
- no effects observed
- External malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- No abortions or fetal malformations were observed in the animals sacrificed on day 25 of pregnancy. No still-born animals were found in the tretment groups and the newborns were free from malformations.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: no (adverse) effects observed
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
No effect was found on the number of pregnancies, the macroscopic and microscopic features of uterus, placenta and ovaries. The number of live births and normal offsprings from the dosed groups was comparable to control, no teratogenic effects were observed.
Applicant's summary and conclusion
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