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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
Description of key information
After 6 months repeated exposure in feed the derived NOEL of the test substance was > 1000 mg/kg bw in rats and > 1500 mg/kg bw in rabbits.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- 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 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 6 month exposure period.
- Principles of method if other than guideline:
- Two groups of twenty Wistar rats (ten ♂ and ten ♀) were fed for 6 months a pellet diet containing Disodium sebacate at two different dosages.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Average weight at study initiation:
♂ 174.6 ±6.3 g; 176.8 ±13.2 g
♀ 142.2 ±7.13 g; 141.7 ±7.54 g - 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
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- 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:
- Surviving animals were sacrificed 181 days after the start of the treatment. Macro- and microscopic examinations of the organs were performed.
- Statistics:
- The disodium sebacate 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 mortality. 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.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The general conditions of the animals determined by physical examination and general observation did not show qualitative toxic signs.
- Mortality:
- no mortality observed
- Description (incidence):
- No death were observed during the chronic toxicity study.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- 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.
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Biological parameters (plasma glucose, BUN, serum creatinine, SGOT,SGPT and Hb) were similar to those of the controls .
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No histological alterations were observed in any of the tissues and organs examined.
- Details on results:
- CLINICAL CHEMISTRY:
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no adverse effects reported
- Key result
- Critical effects observed:
- no
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Deviations:
- yes
- Remarks:
- 6 month exposure period, rabbit as non-rodent, 2 doses levels
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Average weight at study initiation:
♂: 1.33 ±0.140 and 1.36 ±0.10 kg
♀: 1.17 ±0.110 and 1.22 ±0.08 kg - 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:
- continously
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: every 15 days
ORGANS: yes
- Time schedule for examination: at death or after sacrifice.
CLINICAL CHEMISTRY and HAEMATOLOGY: Yes
- Parameters checked: plasma, glucose, BUN, serum creatinin, SGOT, SGPT, Hb. - Sacrifice and pathology:
- Surviving animals were sacrificed 181 days after start of the exposure period. Macro- and microscopic examinations of the organs were performed.
- Statistics:
- The disodium sebacate 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 mortality. 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.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The general conditions of the animals determined by physical examination and general observation did not show any qualitative toxic signs.
- Mortality:
- no mortality observed
- Description (incidence):
- No death were observed during the chronic toxicity study.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food and water consumption were normal, as confirmed by the analysis of body weight gains which were not different from thoses values obtained from the controls.
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Biological parameters (plasma glucose, BUN, serum creatinine, SGOT, SGPT and Hb) were similar to those of the controls.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histological alterations were observed in any of the tissues and organs examined.
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects reported
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the published subchronic key study (Greco, 1990), 10 rats per sex and dose (and also rabbits) were orally exposed to disodium sebacate for 6 months. Doses in rats were 500 and 1000 mg/kg bw/day, in rabbits 750 and 1500 mg/kg bw/day. No death or qualitative toxic clinical signs were observed. Food and water consumption, body weight gain, histology and clinical chemistry were similar to control.
In addition, long-term toxicity data are available for the structurally related compound adipic acid.
In a 19-week study, groups of 8 to 10 male rats received sodium adipate (0, 50, 100, 200 and 400 mg/day, approximately 0, 420, 840, 1700 and 3400 mg/kg bw/day) in a protein deficient diet. After 7 weeks and (probably) at the end of the experiment, rats were killed and examined grossly. Weight gain and general behaviour were recorded and histopathology of liver, kidneys and intestine was performed. Rats fed with 400 mg/day showed reduced weight gain and lower weight after 19 weeks. No obvious symptoms were observed. Several unexplained intercurrent deaths in control and dose groups occurred, and only 5-7 animals in each group survived 19 weeks. Only at 400 mg/day slight effects were seen on liver and irritation of intestine. The NOAEL is 1700 mg/kg bw (Lang and Bartsch 1953). The study is limited in its reliability because no details are provided on the distribution of intercurrent deaths amongst the treatment/control groups and only kidneys, liver and intestine have been examined histopathologically.
In a 33-week study, groups of 13-15 male and female rats received adipic acid (neutralized with NaOH) in a standard diet (0, 400, 800 mg/day, approximately 0, 1600 and 3200 mg/kg bw/day) for 33 weeks. Weight gain and general behavior were recorded. After 8, 23 and 25 weeks, rats were killed and histopathology of liver, kidneys and intestine was performed. The administration of 400 mg/day of adipic acid had no effect on weight gain and general behavior of the animals. Ten out of 14 rats fed with 800 mg/day died during the first 4 weeks. The surviving animals showed retarded weight gain, appeared unkempt and apathetic and suffered from heavy diarrhea during the first three weeks. They recovered by the fifth week, and after 33 weeks, the weights of the high-dose rats were the same as that of the 400 mg/day group. The authors did not record the body weight of control animals at the end of the experiment, i.e. at 33 weeks. Histopathology: slight effects were seen on liver and inflammation of intestine at 400 mg/day. No NOAEL was obtained in this study (Lang and Bartsch 1953). The study is very limited in its reliability because only kidneys, liver and intestine have been examined histopathologically.
In a two-year study, groups of 20 male rats were given 0, 0.1, 1, 3 and 5 % of adipic acid in the diet (equivalent to doses of 0, approximately 75, 750, 2250 and 3750 mg/kg bw/day). Groups of 10 or 19 female rats received food containing 0 or 1 % adipic acid (0 and approx. 750 mg/kg bw/day, respectively). Body weights, food consumption and general appearance were recorded weekly throughout the experimental period. After 2 years, surviving rats were weighed, killed, and examined grossly. The brain, thyroid, lung, heart, liver, spleen, kidneys, adrenals and stomach of the animals were weighed. Microscopic examination of thyroid, lung, heart, liver, spleen, kidneys, adrenals, stomach, pancreas, bone marrow, large and small intestine uterus, ovaries and testes on a representative number of animals (no further information) was performed. The percent survival for each test group was higher than for the control group. There were no body weight differences during the test period in female and male rats treated with 0, 0.1 and 1 % adipic acid. The weight gains of the male rats receiving 3 and 5 % adipic acid were significantly less than the control groups. At necropsy there was no treatment related effect observed. Results of microscopic examination of the organs revealed no compound related effect. The NOAEL was 1 % for male and female rats (approx. 750 mg/kg bw/day) (Horn et al. 1957). The study does not fully comply with the guidelines for chronic studies because microscopic examination of 15 tissues was done on a representative number of animals for each group, females received only one concentration, the MTD was reached only for males, and the purity of adipic acid is not indicated.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The NOAEL was greater than 1000 mg/kg bw. As a result the substance is not considered to be classified for repeated dose oral toxicity under Regulation (EC) No. 1272/2008, as amended for the ninth time in (EC) No. 2016/1179.
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