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EC number: 207-938-1 | CAS number: 502-44-3
- 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:
- May - June, 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older study conducted by the FDA.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Teratologic evaluation of adipic acid in rabbits
- GLP compliance:
- no
- Remarks:
- : study pre-dates GLP
- 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
- Details on test material:
- The test material was adipic acid (FDA substance FDA 71-50). A read across is proposed based on structural similarities between the substances.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- The animals were female Dutch-Belted rabbits.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The test material was administered as a solution in water.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- On day 0, each doe was given an injection of 0.4 ml human chorionic gonadotropin. Three hours later, each doe was inseminated artificially with 0.3 ml diluted semen from a proven donor buck.
- Duration of treatment / exposure:
- 13 days - gestation days 6 to 18
- Frequency of treatment:
- Daily - gestation days 6 to 18
- Duration of test:
- 29 days
- No. of animals per sex per dose:
- Initial group sizes ranged from 13 to 20, the numbers of successfully mated females were: negative control - 11; positive control - 13; 2.5 mg/kg - 10; 12 mg/kg - 11; 54 mg/kg 10; 250 mg/kg - 14.
- Control animals:
- yes, sham-exposed
- Details on study design:
- Beginning on day 6 (day 0 was the day of insemination) and continuing daily through day 18, the females were dosed with adipic acid at the relevant dose levels, by gavage.
On day 29 does were subject to Caesarean section under surgical anaesthesia. A positive control was included: does were dosed with 2.5 mg/kg of 6-aminonictominamide on Day 9.
Examinations
- Maternal examinations:
- Maternal survival and body weights were recorded (days 0, 6, 12, 18 and 29). The urogenital tract of each animal was examined in detail for normality.
- Ovaries and uterine content:
- On day 29, all does were subjected to Caesarean section under surgical anaesthesia and the numbers of corpora lutea, implantation sites, resorption sites and live and dead foetuses were recorded.
- Fetal examinations:
- Body weights of the liver pups were recorded. Foetuses were examined for external congenital abnormalities. The live foetuses from each litter were placed in an incubator for 24 hours to evaluate neonatal survival. All surviving pups were sacrificed, and all pups were examined for visceral abnormalities (by dissection). All foetuses were then cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects/
- Statistics:
- Formal statistical analysis was not performed.
- Indices:
- Total number of resorptions, total number of foetuses, total number of live litters.
- Historical control data:
- No information available.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No maternal toxicity was observed. There was no effect on maternal survival.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There was no effect on nidation or on foetal survival. The number of abnormalities seen in either soft or skeletal tissue of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. No differences between controls and treated groups were found for corpora lutea, implantations, total number of resorptions, total number of foetuses, total number of live litters and foetal weights.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The NOAEL for both maternal and developmental toxicity was 250 mg/kg bw/d.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for both maternal and developmental toxicity was 250 mg/kg bw/d.
- Executive summary:
Rabbits were artificially inseminated on day 0, adipic acid (in water) was administered by gavage on gesatational days 6 through 18 at doses of 0, 2.5, 12, 54 and 250 mg/kg. The positive control group received a single dose of 2.5 mg/kg 6 -aminonicotinamide on day 9. On day 29 all does were subject to Caesarean section for examination of urogenital tract and foetal examination. No maternal toxicity was observed. There was no effect on maternal survival. There was no effect on nidation or on foetal survival. The number of abnormalities seen in either soft or skeletal tissue of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. No differences between controls and treated groups were found for corpora lutea, implantations, total number of resorptions, total number of foetuses, total number of live litters and foetal weights. The NOAEL for both maternal and developmental toxicity was 250 mg/kg bw/d.
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