Registration Dossier
Registration Dossier
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: 242-838-1 | CAS number: 19147-16-1
- 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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP but overall good documentation. 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. No justification for dose selection was given
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratologic Evaluation of Compound FDA 71-50. Adipic Acid in Rabbits.
- Author:
- Food and Drug Administration
- Year:
- 1 974
- Bibliographic source:
- PB-267 202
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- On day 0, each doe was given an injection of 0.4 ml of human chorionic gonadotropin. Three hours later, each doe was inseminated artificially with 0.3 ml of diluted semen from a proven donor buck. Beginning on day 6 and continuing daily through day 18 the females (10-14 animal per dose) were dosed with the indicated dosages by oral intubation. Body weights were recorded on days 0, 6, 12, 18 and 29 of gestation, with particular attention to food consumption and body weight. On day 14 all animals were subjected to cesarean section, and the number of corpora lutea, implantation sites, resorption sites and live and dead fetuses were recorded. The urogenetal tract of each animal was examined in detail for normality. All fetuses underwent a detailed gross examination for the presence of external congenital abnormalities. The live fetuses of each litter were then placed in an incubator for 24 hours for the evaluation of neonatal survival. All surviving pups were sacrificed, and all pups examined for visceral abnormalities and examined for skeletal defects. 6-Aminonicotinamide (2.5 mg/kg), d
- GLP compliance:
- no
- 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:
- hexanedioic acid
- Test material form:
- not specified
- Details on test material:
- Purity not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Dutch belted
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- /
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- /
- Details on mating procedure:
- On day 0, each doe was given an injection of 0.4 ml of human chorionic gonadotropin. Three hours later, each doe was inseminated artificially
- Duration of treatment / exposure:
- 13d
- Frequency of treatment:
- 6.-18. gestation day, daily
- Duration of test:
- all animals were subjected to cesarean section on GD 29
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2.5 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
12 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
54 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
250 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- 10-14 females per dose
- Control animals:
- yes
Examinations
- Maternal examinations:
- /
- Ovaries and uterine content:
- /
- Fetal examinations:
- /
- Statistics:
- /
- Indices:
- /
- Historical control data:
- /
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Details on maternal toxic effects:
/
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 250 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no data
Details on embryotoxic / teratogenic effects:
/
Effect levels (fetuses)
- Remarks on result:
- not measured/tested
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
No adverse effects were seen in similar experiments after administration of adipic acid to groups of 10 to 14 pregnant rabbits (gd 6-18, up to 250 mg/kg bw/day; Food and Drug Res Labs, Inc. 1974). This study is limited to some extent by the fact that no signs of maternal toxicity have been observed and the highest doses tested , a dose below the limit dose of 1000 mg/kg bw.
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.
