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EC number: 242-838-1 | CAS number: 19147-16-1
- 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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1957
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP, short description of the results, low number of animals, few organs examined, unclear number of animals examined, only one dose for females, purity not specified.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were fed either the basal laboratory diet, or the basal diet to which adipic acid was added. Body weights, food consumption, and general appearance were recorded weekly throughout the experimental period. Whenever possible, gross autopsy was performed on those animals that died during the course of the experiment. After two years, surviving rat were weighed, killed, and examined grossly. The brain, thyroid, lung, heart, liver, spleen, kidneys and adrenals, stomach of approximately half of each group of males were weighed. The kidneys, spleen, liver and heart of each female were weighed. Microscopic examination of thyroid, lung, heart, liver, spleen, kidneys, adrenals, stomach, pancreas, bone marrow, large and small intestine and testis or ovaries and uterus on a representative number of animals was performed.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth Farm strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- /
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- /
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- /
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- diet ad libitum
- Remarks:
- Doses / Concentrations:
75 mg/kg bw
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
750 mg/kg bw
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
2250 mg/kg bw
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
3750 mg/kg bw
Basis:
nominal in diet - No. of animals per sex per dose:
- 19-20 males or females per group
- Control animals:
- other: basal laboratory diet
- Details on study design:
- /
- Positive control:
- /
- Observations and examinations performed and frequency:
- /
- Sacrifice and pathology:
- /
- Other examinations:
- /
- Statistics:
- /
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- /
- Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: /
- Critical effects observed:
- not specified
- Executive summary:
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.
Reference
Males: The percent survival for each test group was higher than for the control group. During the rapid growth of the 2-year feeding studies, weight gains for the male rats receiving 3 or 5% adipic acid was significantly less than the male controls. Growth for other groups, 0.1, 1% male and 1% female, was comparable to that of the respective controls. At the end of the study the body weight of males was reduced by 10% and more in the two highest exposure groups. There was slight, but consistent, reduction in food consumption at 5%. Compound Sex No. of rats Average body [%] in diet m/f start/finish weight initial/final [g] 0 m 20/8 59/440 0 f 10/8 49/321 0.1 m 20/13 61/417 1 m 20/15 63/437 1 f 19/17 48/304 3 m 20/16 61/400 5 m 20/15 57/360 There was no evidence of gross pathology associated with the feeding of adipic acid. There was no significant difference in survival. The results of microscopic examination were to be within normal limits. The following signs were observed among all male groups, including the controls, especially during the final six months: wheezing, blood-tinged crust about the noses and eyes, and body sores. These findings were not significantly different among the groups although a lower incidence of signs indicative of respiratory infection and body sores occurred in the 5% adipic acid group. Autopsy data for the male animals that died during the course of the two-year feeding program and for the sacrificed rats were analyzed for incidence of tumors and/or lung pathology. The incidence of lung pathology, tumors, soft testes observed in the adipic acid treated groups was as frequent as in the control group. Female animals, dosed with 1% adipic acid and controls, exhibited signs normally associated with advancing senility in rats in the last six months. There was an equal incidence of blood-tinged crust about the eyes and noses, unthriftiness, and body scores in both groups. A few control and experimental animals had alopecia, and one experimental rat appeared to develop a middle ear infection during the 102nd week. One experimental and two control animals died during the final six months. All three exhibited diarrhea, respiratory infection and loss of body weight prior to death. Upon autopsy, one control rat and one experimental rat were found to have tumors, while the other control animal had a granular liver and dark red apexes on both lungs. When surviving animals were sacrificed at the end of the two-year period, there was no significant gross pathology that could be related to ingestion of the compound. There was an equal incidence of mottled, granular livers with peripheral thickening in both the control and experimental animals. Two of the surviving control animals and one of the experimental animals had ovarian tumors, ovarian cysts were noted in both control and experimental rats.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- No GLP, short description of the results, low number of animals, few organs examined, unclear number of animals examined, only one dose for females, purity not specified.
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
An inhalation repeated dose toxicity test was waived, based on the vapour pressure of the substance. The vapour pressure is low, which makes the intake of the substance by inhalation negligible.
A dermal repeated dose toxicity test was waived as the toxicological properties of the substance suggest low potential for a significant rate of absorption through the skin. Furthermore the results of laboratory animal studies performed with adipic acid show low acute dermal toxicity. In the 28 - days repeated dose study via oral gavage administration does not exacerbate systemic toxicity effects which suggest bioavailability is low, thereby there is low toxicity potential. This intrinsic property/toxicity potential can be extrapolated to repeated dermal route administration.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available
Justification for classification or non-classification
The substance is not classified according to CLP-Regulation (EC) No 1272/2008. Potassium adipate will dissociate into potassium and adipate ions and hence can be regarded as a mixture of both constituent ions. The classification as hazardous to human health is therefore based on the classification of its moieties (K and adipic acid). Both potassium and adipic acid are not classified as STOT-RE, and according to the summation method, it is concluded that potassium adipate is not classified as STOT-RE.
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