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EC number: 217-440-6 | CAS number: 1852-04-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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: Comparable to guideline study with acceptable restrictions (no data on GLP status, name of organs examined not stated, reduced clinical chemistry)
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:
- The test animals were continuously fed a diet containing the test substance for 6 months. During the feeding period, animals were checked for signs of toxicity and substance-dependent mortality. Gross pathological findings of the animals too were also monitored and recorded before, during and at the end of the observation period. Body weight were taken every 15 days. All surviving animals were sacrificed on day 181, necropsied and histological examination of the different organs was performed.
- GLP compliance:
- not specified
- Limit test:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Average weight at study initiation:
Male: 174.6 ± 6.3 g; 176.8 ± 13.2 g
Female: 142.2 ± 7.13 g; 141.7 ± 7.54 g
Two groups of twenty Wistar rats (ten males and ten females) were fed for 6 months a pellet diet containing IDSS at two different dosages : 500 mg/kg b.w. for the first group and 1000 mg/kg b.w. for the second group.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: pellet diet containing the test substance
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 months
- Frequency of treatment:
- continuously
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500; 1000 mg/kg bw
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- The growth curve of rats was drawn based on the body weight at 15-day intervals.
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: every 15 days
ORGAN: yes
- Time schedule for examination: at death or after sacrifice.
- Organs examined: no data
CLINICAL CHEMISTRY and HAEMATOLOGY: Yes
- Parameters checked: plasma, glucose, BUN, serum creatinin, SGOT, SGPT, Hb. - Sacrifice and pathology:
- Surving animals were sacrificed 181 days after begin of feeding and macro- and microscopic examinations of the organ were performed.
- Statistics:
- The DSS concentration used and percentage of mortality were respectively plotted on abscissa and ordinate of a logarithmic paper according to Miller and Tainter The best fitting straight line of the plotted points allows calculation of the LD50 which is the dosage value at 50% of mortalit . The standard error (s.e.) was estimated by this formula : (doses 84% - 16%) x square root of 2N, where N is the number of animals contributing to the values plotted.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Details on results:
- MORTALITY:
No death were observed during the chronic toxicity study.
CLINICAL SIGNS:
The general conditions of the animals determined by physical examination and general observation did not show qualitative toxic signs.
FOOD AND WATER CONSUMPTION:
Food and water consumption were normal, as confirmed by the analysis of body weight gains which were not different from those values obtained from the controls.
HISTOPATHOLOGY:
No histological alterations were observed in any of the tissues and organs examined
CLINICAL CHEMISTRY:
Biological parameters (plasma glucose, BUN, serum creatinine, SGOT, SGPT and Hb) were similar to those of the controls
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- After oral administration of disodium sebacate on rats for a 6 months period, no mortality and clinical signs were observed. Based on a read across (category approach), undecanedioic acid is not expected to show subchronic oral toxicity.
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