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EC number: 272-810-4 | CAS number: 68915-38-8
- 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:
- toxicity to reproduction
- Remarks:
- other: chronic two-year study
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1957
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP, short documentation, unclear number of animals examined histopathologically, 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:
- see repeated dose toxicity Horn et al. 1957. 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:
- Hexanedioic 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
- Details on mating procedure:
- no mating
- Duration of treatment / exposure:
- Exposure period: 2 years
- Frequency of treatment:
- diet ad libitum
- Details on study schedule:
- 2 year cancer study
Doses / concentrations
- Remarks:
- Doses / Concentrations:
male rats: 0, 0.1, 1, 3, and 5%; (ca. 75, 750, 2250, 3750 mg/kg bw/day) female rats: 0, 1%; (ca. 750 mg/kg bw/day)
Basis:
- No. of animals per sex per dose:
- 19-20 per sex and dose
- Control animals:
- yes
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
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 controls. Growth for other groups, 0, 0.1, 1% male and 0,1% female, was comparable to that of the respective controls. There was no evidence of gross pathology associated with the feeding of adipic acid (see Repeated Dose Toxicity).
Males (control, 0.1, 1, 3, 5% adipic acid; 20 male animals/group): When the surviving males were sacrificed there was no significant gross pathology that could be related to Adipic acid. Histopathologic examination of the testes revealed no evidence of an adverse effect on the reproductive organs up to the highest dose. Soft edematous testes were noted at least as frequent in the controls as in the experimental animals.
Females (10 control animals and 19 animals dosed with 1% adipic acid): When the surviving females were sacrificed there was no significant gross pathology that could be related to Adipic acid. Histopathologic examination of the ovaries and uterus revealed no evidence of an adverse effect on the reproductive organs. 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.
In summary: histopathologic examination of the testes, ovaries and uterus revealed no evidence of an adverse effect on the reproductive organs.
Applicant's summary and conclusion
- Executive summary:
Studies on fertility are not available. In the previously described two-years feeding study in rats (see chapter 3.1.5. Repeated Dose Toxicity) 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). 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
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