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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
no data available
Additional information
There were no specific experimental studies concerning fertility available. In a subchronic oral toxicity study (Greco et al., 1990), male and female rats were fed with a pellet diet for 180 days (rats: 500 or 1000 mg/kg nominal). No adverse effects on reproductive organs or tissues were reported as well as normal number of pregnancies, live births, and normal offspring were observed. In conclusion, disodium sebacate is very unlikely to impair reproductive capacity of both sexes. Therefore, no fertility study was proposed, since it was not assumed to reveal new information regarding toxicological effects on fertility.
Effects on developmental toxicity
Description of key information
No maternal or embryotoxic/teratogenic effects were observed at 500 mg/kg nominal diet in rats (Greco, 1990).
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- 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 - 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
- Dose / conc.:
- 500 other: mg/kg nominal in diet
- No. of animals per sex per dose:
- 10 animals per group
- Control animals:
- yes
- 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
- Clinical signs:
- no effects observed
- Gross pathological findings:
- no effects observed
- 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.
- 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
- Abnormalities:
- no effects observed
- 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.
- 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
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
Reference
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.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Additional information
In a teratogenicity study, female rats and rabbits were fed with disodium sebacate after a 10 days mating period. The females were fed with disodium sebacate during pregnancy (rats: 500 mg/kg bw up to day 19 of pregnancy, rabbits: 1000 mg/kg bw up to day 25 of pregnancy) one group each was also fed for 3 months after the mating period. No effects were found on the number of pregnancies and the macroscopic and microscopic features of uterus, placenta and ovaries. Also the number of live births and the offspring, defined either anatomically or physiologically, were similar in both treated and control animals. The teratogenic investigations showed that there was no abnormality or malformation in the progeny of both rats and rabbits.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A NOEL of > 500 mg/kg bw/day was determined in rats. As a result the substance is not considered to be classified for toxicity for reproduction under Regulation (EC) No. 1272/2008, as amended for the ninth time in Regulation (EC) No. 2016/1179.
Additional information
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.
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