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Diss Factsheets
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EC number: 212-476-9 | CAS number: 821-38-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
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
- Principles of method if other than guideline:
- Following a 10 day mating period, each female animal (total of 20 animals) was placed in a single cage and fed a pellet diet containing the test substance or no test substance in the case of the controls for 25 days after which 10 animal were sacrificed. Treatment of the remaining 10 female animals was continued for another 3 months including the period of suckling. At the end, the animals were also sacrificed. Fetuses and reproduction organs of all animals (uterus, placenta, ovaries) were weighed post mortem and examined macroscopically as well as histologically.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium sebacate (DSS)
- IUPAC Name:
- Disodium sebacate (DSS)
- Reference substance name:
- Disodium sebacate
- EC Number:
- 241-300-3
- EC Name:
- Disodium sebacate
- Cas Number:
- 17265-14-4
- IUPAC Name:
- disodium sebacate
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: pellet diet
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- The male and female animals were cohoused at a ratio of 1 male to 20 females for 10 days in a metabolic cage.
- 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 - Frequency of treatment:
- continuously
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
nominal in 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
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
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: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
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 DSS groups and the newborns were free from malformations.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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 effect was observed.
Applicant's summary and conclusion
- Conclusions:
- No teratogenic effect was observed on animals after oral adminidtration of disodium sebacate. Based on a read across (category approach), tetradecanedioic acid is not expected as well to show teratogenic effects.
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