Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Repeated dose toxicity: oral
Administrative data
- 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.
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
- 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
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
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- diet ad libitum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1, 1, 3 and 5 % (approx. 75, 750, 2250, 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
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 other: % in diet (approx. 750 mg/kg/day)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.