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Diss Factsheets
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EC number: 222-037-3 | CAS number: 3323-53-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study did not include a high dose that caused maternal toxicity, low number of animals per group, no statistical evaluation. Data on purity of adipic acid are lacking, but as no effects were observed up to the highest dose tested this is thought not to impair the validity of the results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Principles of method if other than guideline:
- On gestation day 6 through 18, pregnant rabbits were dosed daily with the test substance by oral intubation. Animals were observed daily for clinical signs, food consumption and body weight were determined. On Day 29 all does were subjected Caesarean section, the uterine contents were examined, and the foetuses were examined for fetotoxicity and teratogenicity.
- GLP compliance:
- no
- Remarks:
- pre-GLP data
- Limit test:
- 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:
- Component of the test substance.
- Name of test material (as cited in study report): Adipic acid
- Physical state: fine white crystalline
- Analytical purity: not stated
No further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Virgin adult, Dutch-belted female rabbits
- Housing: individually in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
temperature and humidity controlled quarter
No further data.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
On Day 0, each doe was given an injection of 0.4 ml of human chorionic gonadotropin (400 IU) via the marginal ear vein. Three hours later, each doe was inseminated artificially with 0.3 ml of diluted semen from a proven donor buck using approximately 20 x 10E6 motile sperm.
No further details. - Duration of treatment / exposure:
- days 6 through 18 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 29 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 12 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 54 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 13 females (2.5 mg/kg bw/d);
15 females (54 mg/kg bw/d);
16 females per group (12 mg/kg bw/d, positive control);
19 females (sham-treated control);
20 females (250 mg/kg bw/d) - Control animals:
- yes, sham-exposed
- other: Positive control: 6-Aminonicotinamide, 2.5 mg/kg bw (actual ingested), dosed on day 9 of gestation
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS and DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
All animals were observed daily for appearance and behavior.
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6, 12, 18, and 29 of gestation.
FOOD CONSUMPTION: Yes
- Time schedule: daily
All animals were observed daily with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
All does were subjected to Caesarean section under surgical anesthesia.
- Organs examined: gravid uterus, urogenital tract - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- The live fetuses of each litter were placed in an incubator for 24 hours for the evaluation of neonatal survival.
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: No
Other: The body weights of the live pups were recorded. - Statistics:
- The results were not evaluated statistically.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
- Description (incidence):
- The administration of the test substance up to the highest dose level had no clearly discernible effect on nidation or on maternal survival.
Maternal developmental toxicity
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- No differences between treatment and control groups were found for total number of resorptions.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: no adverse effects observed up to and including the highest tested dose
Results (fetuses)
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): No differences between treatment and control groups were found for fetal weight. - Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- No differences between treatment and control groups were found for total number of live litters.
- Changes in postnatal survival:
- no effects observed
- Description (incidence and severity):
- The administration of the test substance up to the highest dose level had no clearly discernible effect on fetal survival.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
- Details on embryotoxic / teratogenic effects:
- No differences between treatment and control groups were found for corpora lutea, implantations, and total number of fetuses.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: no adverse effects observed up to and including the highest tested dose
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
For details, see attached documents.
Applicant's summary and conclusion
- Executive summary:
The administration of the test substance, adipic acid, at doses of up to 250 mg/kg bw/d to pregnant rabbits for 13 consecutive days (gd 6 - 18) had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
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