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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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- pre-GLP, purity not specified, no positive control for every experiment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
- Reference Type:
- publication
- Title:
- Mutagenic Evaluation of Compound FDA 71- 50, Adipic Acid
- Author:
- Litton Bionetics, Inc.
- Year:
- 2 001
- Bibliographic source:
- cited in: OECD SIDS, dicarboxylic acid category, 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 5 treated and 3 control animals were used. Animals were killed 6, 24 and 48 hours after a single administration in the acute study. In the subacute study 5 doses, 24 hours apart, were administered and animals were killed 6 hours after the last dose. Four hours after the last compound administration, and two hours prior to killing, each animal was given 4 mg/kg bw of colcemid intraperitoneally in order to arrest the bone marrow cells in mitosis. The marrow "plug" was removed and aspirated into Hanks' balanced salt solution. The specimen were centrifuged and resuspended in hypotonic 0.5% KCl. The specimens were placed in a 37 degree Celsius water bath in order to swell the cells. Following centrifugation the cells were resuspended in a fixative (3:1 absolute methanol : glacial acetic acid) and again centrifuged. Cells were resuspended and placed at 4 degree Celsius overnight. The following day cells were again centrifuged and freshly prepared fixative was added. The suspension was dropped onto a slide and ignited by an alcohol burner and allowed to flame. Slides were stained with 5% Giemsa solution. The preparations were examined by microscopy. The chromosomes of each cell were counted and only diploid cells were analyzed. They were scored for chromatid gaps and breaks, chromosome gaps and breaks, reunions, cells with greater than ten aberrations, polyploidy, pulverization, and other chromosomal aberrations which were observed. Fifty metaphase spreads were scored per animal. Mitotic indices were obtained by counting at least 500 cells and the ratio of the number of cells in mitosis / the number of cells observed was expressed as the mitotic index. Negative and positive (TEM) controls were run in each experiment. Two tests were performed at different time intervals.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of assay:
- mammalian bone marrow chromosome aberration test
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Acute study: single dosing
Subacute study: once a day for 5 consecutive days - Frequency of treatment:
- Acute study: single dosing
Subacute study: once a day for 5 consecutive days - Post exposure period:
- Animals were killed 6, 24 and 48 hours after a single administration in the acute study.
In the subacute study 5 doses, 24 hours apart, were administered and animals were killed 6 hours after the last dose.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3.75 mg/kg bw/day
- Remarks:
- acute and subacute study
- Dose / conc.:
- 37.5 mg/kg bw/day
- Remarks:
- acute and subacute study
- Dose / conc.:
- 375 mg/kg bw/day
- Remarks:
- acute and subacute study
- Dose / conc.:
- 2 500 mg/kg bw/day
- Remarks:
- subacute study
- Dose / conc.:
- 5 000 mg/kg bw/day
- Remarks:
- acute study
- No. of animals per sex per dose:
- Groups of 5 treated/dose and 3 control male animals were used.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylenemelamine (TEM)
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
Four hours after the last compound administration, and two hours prior to sacrifice, each animal was given 4 mg/kg bw of colcemid intraperitoneally in order to arrest the bone marrow cells in mitosis. The marrow "plug" was removed and aspirated into Hanks' balanced salt solution. The specimen were centrifuged and resuspended in hypotonic 0.5 % KCl. The specimens were placed in a 37 °C water bath in order to swell the cells. Following centrifugation the cells were resuspended in a fixative (3:1 absolute methanol : glacial acetic acid) and again centrifuged. Cells were resuspended and placed at 4 °C overnight. The following day cells were again centrifuged and freshly prepared fixative was added. The suspension was dropped onto a slide and ignited by an alcohol burner and allowed to flame. Slides were stained with 5 % Giemsa solution.
METHOD OF ANALYSIS:
The preparations were examined by microscopy. The chromosomes of each cell were counted and only diploid cells were analyzed. They were scored for chromatid gaps and breaks, chromosome gaps and breaks, reunions, cells with greater than ten aberrations, polyploidy, pulverization, and other chromosomal aberrations which were observed. Fifty metaphase spreads were scored per animal. Mitotic indices were obtained by counting at least 500 cells and the ratio of the number of cells in mitosis / the number of cells observed was expressed as the mitotic index.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test 1 (3.75, 37.5 and 375 mg/kg bw/day dosing):
Acute study: The negative control group cells contained no aberrations. The compound produced no aberrations except for one cell containing a break in the 6-hour sample of the intermediate dose level. The expected severe chromosomal damage was observed for the positive control group (triethylenemelamine treated animals). The mitotic indices were within normal limits. Negative and positive controls were functional.
Subacute study (5 days): The negative control group and the low level test group contained no aberration. The intermediate level contained one cell with a reunion and one cell that was polyploid. The highest level contained three cells with breaks and one fragment. These were considered to be within the normal limits of the historical negative controls of the laboratory. Negative control was functional. No positive control was performed.
Test 2:
Acute study: Adipic acid was administered at a single dose of 5000 mg/kg bw. The compound produced no aberrations except for 3 cells with polyploidy (2 in the 6-hour sample and 1 in the 24-hour). Neither the variety nor the number of these aberrations differed significantly from the negative controls (polyploidy observed in 4 cells). Negative and positive controls were functional.
Subacute study (5 days, 2500 mg/kg bw/day). Only 218 metaphases have been evaluated. The compound produced no aberrations except for 1 cell with polyploidy. Polyploidy was also observed in the negative control group. These are considered to be within the normal limits of the historical negative controls. Negative control was functional, no positive control.
Applicant's summary and conclusion
- Conclusions:
- In summary, the test substance can be considered non-mutagenic in the cytogenetic test.
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