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EC number: 231-293-5 | CAS number: 7486-38-6
- 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
Endpoint summary
Administrative data
Description of key information
There are no data available for disodium adipate. The IUCLID dataset and the present Human Health Hazard Assessment is based on the recent OECD/ICCA evaluation of adipic acid. For all systemic endpoints the hazards identified and discussed in the OECD SIDS Initial Assessment Report for adipic acid in 2004 are cited and additional updated relevant information is given in a separate heading. In aqueous media, disodium adipate and adipic acid acid dissociate into the corresponding anion (1,6-hexandioic acid ion) and the sodium ion and hydrogen ion (proton), respectively. Systemic toxicity of adipic acid and its disodium salt are thought to be an effect of the di-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in living systems and have no relevant toxicological properties at relevant doses. Therefore data on adipic acida are taken to evaluate the systemic toxicity of disodium adipate.
Data on adipic acid: In a 2-year oral study adipic acid was of low repeated dose toxicity, however it was not tested according to modern standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. In humans no symptoms were reported after oral administration of up to 7 g adipic acid per day for up to 10 days to 7 volunteers to investigate compound excretion.
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:
- supporting study
- Study period:
- 1953
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP, short documentation, purity of test compound not specified
- Principles of method if other than guideline:
- Groups of 8-10 animals with a weight of 40-60 g received adipic acid in a protein deficient diet (crushed wheat supplemented with cod liver oil and protein concentration of 11%). Weight gain and general behavior were recorded. After 7 weeks and (probably) at the end of the experiment, rats were killed and examined grossly. Weight gain and general behavior were recorded and histopathology of liver, kidneys and intestine was performed. Body weight at start of experiment approx. 53-54 g, after 6 weeks approx. 79-104 g, and at end of experiment (19 weeks) approx. 144 - 200 g.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Duration of treatment / exposure:
- 19 w
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0, 50, 100, 200, 400 mg/day (0, 420, 840, 1700, and 3400 mg/kg bw/day)
Basis:
nominal in diet - No. of animals per sex per dose:
- 8 to 10 males per dose
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no data
- Dose descriptor:
- NOAEL
- Effect level:
- 200 other: mg/day (approx. 1700 mg/kg/day)
- Sex:
- male
- Critical effects observed:
- not specified
- Executive summary:
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 for 19 weeks. 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.
Reference
The administration of 50, 100 and 200 mg/day of the
compound had no effect on weight gain or general behavior.
Rats fed wit 400 mg/day showed retarded weight gain. These
animals did not recover, and after 19 weeks, these rats were still
retarded.
No other obvious symptom were observed.
Several unexplained intercurrent deaths in control and dose
groups were reported; only 5-7 animals survived 19 weeks.
Histopathology: no effects observed in animals dosed with =<
200 mg. At higher doses (400 mg) slight effects were seen
on liver and irritation of intestine.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Quality of whole database:
- No data on disodium adipate available; OECD/ICCA high production volume chemicals program on adipic acid evaluated the data in 2004.
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
There are no data available for disodium adipate. The IUCLID dataset and the present Human Health Hazard Assessment is based on the recent OECD/ICCA evaluation of adipic acid. For all systemic endpoints the hazards identified and discussed in the OECD SIDS Initial Assessment Report for adipic acid in 2004 are cited and additional updated relevant information is given in a separate heading. In aqueous media, disodium adipate and adipic acid acid dissociate into the corresponding anion (1,6-hexandioic acid ion) and the sodium ion and hydrogen ion (proton), respectively. Systemic toxicity of adipic acid and its disodium salt are thought to be an effect of the di-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in living systems and have no relevant toxicological properties at relevant doses. Therefore data on adipic acida are taken to evaluate the systemic toxicity of disodium adipate.
Hazards identified by OECD/ICCA high production volume chemicals program in 2004:
Animal data
"Oral toxicity:
In a limited three-weeks feeding study four rats were dosed with food containing 2% adipic acid (approximately 1500 mg/kg bw/day) no differences were observed compared to control animals in general behavior, liver size, peroxisome proliferation, hepatic activities of catalase and carnitine acetyltransferase, and no hypolipidemia was seen (Moody and Reddy 1978).
Groups of 8 to 10 male rats received neutralized adipic acid (0, 50, 100, 200 and 400 mg/day, approximately 0, 833, 1666, 3333, 6666 mg/kg bw/day) in a protein deficient diet for 19 weeks. 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 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 survived 19 weeks. Only at 400 mg/day slight effects were seen on liver and irritation of intestine. The NOAEL is 3333 mg/kg bw (Lang and Bartsch 1953). The study is very limited in its reliability because only kidneys, liver and intestine have been examined histopathologically.
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, 5000, 10000 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. Histopathology: slight effects were seen on liver and irritation of intestine at 400 mg/day. No NOAEL was obtained in this study (Lang and Bartsch 1953). The study bis very limited in its reliability because only kidneys, liver and intestine have been examined histopathologically.
In a two-years feeding study rats were fed with food containing different amounts of adipic acid. 20 male rats per group received food containing 0, 0.1, 1, 3 and 5 % of adipic acid (0, approximately 75, 750, 2250, and 3750 mg/kg bw/day), respectively, and 10 or 19 female rats per group received food containing 0 or 1% (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 to be within normal limits in all groups. 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."
Inhalation
"There is no study with histopathological examination of the nose, the probable target organ after inhalation, available. Systemic effects after repeated inhalation have not been investigated in fully valid studies. However, repeated dose studies with application via the food (see below) reveal a low systemic toxicity of adipic acid."
Dermal toxicity:
"No data available"
Human information
Oral toxicity:
"Adipic acid was orally administered to 7 volunteers to investigate excretion of this compound. No symptoms were reported in subacute studies with doses of up to 7 g adipic acid per day administered for up to 10 days (Weitzel 1942 and 1947)."
Inhalation toxicity:
" 7 of 12 workers exposed (for an average of 9.2 years) to various glycols and adipic acid dust particles (concentration 0.47-0.79 mg/m3 [0.08-0.13 ppm], 8 h average value) complained of mucosal irritation (eye, nose, throat). There was no local exhaust ventilation and the workers did not wear respiratory protection. They reported that clouds of adipic acid and other materials were routinely generated during charging of reaction vessels. The investigators suggested that, since the glycol level was kept below 1 ppm, adipic acid was more likely to be the cause of these complaints (Cummings and Roseman 1985). Due to the acidic character of the substance, a local irritation potential is plausible."
Updated relevant information:
None
Justification for classification or non-classification
Disodium adipate is considered to be of low toxicity after repeated oral application; no classification is required according to the EU classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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