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Diss Factsheets
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EC number: 241-300-3 | CAS number: 17265-14-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
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:
- rat
- Strain:
- Wistar
- 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: 500 mg/kg - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/20
- Length of cohabitation: 10 days
- Any other deviations from standard protocol: cohouse in a metabolic cage - Duration of treatment / exposure:
- Group 1: 10 animals: day 1 to 19 of pregnancy
Group 2: 10 animals: day 1 to 19 of pregnancy, plus 3 months, including the suckling period - Frequency of treatment:
- continuously
Doses / concentrations
- Dose / conc.:
- 500 other: mg/kg nominal in diet
- No. of animals per sex per dose:
- 10 animals 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)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 500 mg/kg bw/day
- Basis for effect level:
- changes in number of pregnant
- clinical signs
- gross pathology
- necropsy findings
- number of abortions
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- 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 19 of pregnancy. No still-born animals were found in the treatment groups and the newborns were free from malformations.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 500 mg/kg bw/day
- Basis for effect level:
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
There was no effect 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 and no teratogenic effects were observed.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.