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EC number: 203-845-5 | CAS number: 111-20-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- chronic two-year study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1957
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- no GLP, short documentation, unclear number of animals examined histopathologically, only one dose for females, purity not specified
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1957
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- no GLP, short description of the results, low number of animals, few organs examined, unclear number of animals examined histopathologically, 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:
- Albino rats (male/female) were housed individually and fed for two years with the test substance.
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
- Species:
- rat
- Strain:
- other: Carworth Farm
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean weights between 50-60 g
- Housing: individually in floor mesh wired cages
- Diet: basal labaratory diet, ad libitum
- Water: ad libitum - Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- diet ad libitum
- Post exposure period:
- no
- Dose / conc.:
- 0.1 other: % (males)
- Remarks:
- equivalent to approx. 75 mg/kg bw/d nominal in diet
- Dose / conc.:
- 1 other: % (males/females)
- Remarks:
- equivalent to approx. 750 mg/kg bw/d nominal in diet
- Dose / conc.:
- 3 other: % (males)
- Remarks:
- equivalent to approx. 2250 mg/kg bw/d nominal in diet
- Dose / conc.:
- 5 other: % (males)
- Remarks:
- equivalent to approx. 3750 mg/kg bw/d nominal in diet
- No. of animals per sex per dose:
- 19-20 per sex and dose
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: weekly throughout the study
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly throughout the experimental period
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean weekly diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER:
- gross autopsy was performed on those animals that died during the course of the experiment - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- weighing: brain, thyroid, lung, heart, liver, spleen, kidneys and adrenals, stomach of approximately half of each group of males; kidneys, spleen, liver and heart of each female
HISTOPATHOLOGY: Yes
- microscopic examination: 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 - Statistics:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - male rats receiving 3 or 5 % test substance: weight gain was significantly reduced compared to the controls
At the end of the study the body weight of males was reduced by 10% and more in the two highest exposure groups. - Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- There was slight, but consistent, reduction in food consumption at 5%.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- - no evidence of gross pathology associated with the feeding of the test substance
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Autopsy data for the male animals that died during the course of the two-year feeding program and for the sacrificed rats were analysed for incidence of tumors and/or lung pathology.
Upon autopsy, one female control rat and one experimental rat were found to have tumors. 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.
Details are given below in the section "any other information". - Dose descriptor:
- NOAEL
- Effect level:
- > 3 750 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no caricnogenic effect up to the highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- > 750 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no carcinogenic effect up to the highest dose tested
- Critical effects observed:
- no
- Executive summary:
The test substance was not carcinogenic in a two-years feeding study where groups of twenty male rats were dosed with food containing 0, 0.1, 1, 3 and 5 % adipic acid (approx. 0, 75, 750, 2250, 3750 mg/kg bw/day), and female rats were dosed with 0 (n = 10) and 1 % (n = 19) adipic acid (approx. 0, 750 mg/kg bw/day), respectively. Animals that died during the study and survivors were analyzed for incidences of tumor growth and lung pathology. The incidences of tumors observed in the adipic acid treated groups were as frequent as in the control groups. The study does not comply with the current guidelines for carcinogenicity studies because the number of animals used was low, microscopic examination of only 15 tissues was done only on a representative number of animals for each group, only one concentration was tested for females, the MTD for females was not reached, and the purity of adipic acid is not indicated.
Autopsy data for the male animals:
(Depicted are animals that died during the course of the 2 -year feeding program or which were sacrificed. A tumor is defined as having a gross evidence of being a new growth present.)
Male group: 0/0.1/1/3/5% test substance
Deaths (N):
total deaths: 12/7/5/4/5
lung pathology: 7/3/1/3/-
tumors: 3/2/2/-/4
other causes: 3/3/2/1/1
Sacrificed (N):
lung pathology: 4/7/7/3/4
tumors: 1/2/2/-/-
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety of adipic acid as compared with citric and tartaric acid.
- Author:
- Horn HJ, Holland EG, Hazleton LW
- Year:
- 1 957
- Bibliographic source:
- Agricult. Food Chem. 5, 759-762.
Materials and methods
Test guideline
- 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. Organs were weighed. Microscopic examination of several organs, including testis or ovaries and uterus was performed on a representative number of animals.
- GLP compliance:
- no
Test material
- Reference substance name:
- Adipic acid
- EC Number:
- 204-673-3
- EC Name:
- Adipic acid
- Cas Number:
- 124-04-9
- Molecular formula:
- C6H10O4
- IUPAC Name:
- adipic acid
- Details on test material:
- Test substance purity not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Carworth Farm strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:
mean weights between 50-60 g
- Housing:
individually in floor mesh wired cages
- Diet: basal labaratory diet, ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Details on mating procedure:
- no mating
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- diet ad libitum
- Details on study schedule:
- 2 year cancer study
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.1 other: % (males)
- Remarks:
- equivalent to approx. 75 mg/kg bw/d nominal in diet
- Dose / conc.:
- 1 other: % (males/females)
- Remarks:
- equivalent to approx. 750 mg/kg bw/d nominal in diet
- Dose / conc.:
- 3 other: % (males)
- Remarks:
- equivalent to approx. 2250 mg/kg bw/d nominal in diet
- Dose / conc.:
- 5 other: % (males)
- Remarks:
- equivalent to approx. 3750 mg/kg bw/d nominal in diet
- No. of animals per sex per dose:
- 19-20 per sex and dose
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: no data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - male rats receiving 3 or 5 % test substance: weight gain was significantly reduced compared to the controls
At the end of the study the body weight of males was reduced by 10% and more in the two highest exposure groups. - Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- There was slight, but consistent, reduction in food consumption at 5%.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- - no evidence of an adverse effect on the reproductive organs (testes) up to the highest dose
- soft edematous testes noted at least as frequent in the controls as in the experimental animals - Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - 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
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 3 750 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- NOAEL
- Effect level:
- > 750 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Soft edematous testes were observed at least as frequent in the controls as in the adipic acid dosed animals. Two of the surviving control female animals and one of the experimental females had ovarian tumors, ovarian cysts were noted in both control and experimental rats.
Histopathological examination of testes, ovaries and uterus revealed no evidence of an adverse effect on the reproductive organs up to the highest tested doses (3750 mg/kg bw/day in males, 750 mg/kg bw/day in females).
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