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EC number: 271-678-5 | CAS number: 68603-87-2
- 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:
- 1972
- 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, no statistical evaluation. Data on purity of adipic acid are lacking. No justification for dose selection was given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
- Principles of method if other than guideline:
- The administration of up to 263 mg/kg bw/day of the compound to pregnant mice for 10 consecutive days had no effect on nidation or on maternal or
fetal 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 maternal toxicity observed. The results were not evaluated statistically, but inspection of the tables shows no effects in the treated groups vs.control. - 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:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- vigin adult female albino CD-1 outbred mice
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- mice were gang-housed in disposable plastic cages in temperature and humidity-controlled quarters with free acess to food and fresh tap water. The controls were treated with the vehicle equivalent to the animals in the test dose groups.
- Details on mating procedure:
- Virgin adult females (20 animals per group) were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.
- Duration of treatment / exposure:
- 10 d
- Frequency of treatment:
- 6.-15. day of gestation, daily
- Duration of test:
- On day 17 all animals were subjected to cesarean section
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.6 mg/kg bw/day
- Dose / conc.:
- 12 mg/kg bw/day
- Dose / conc.:
- 56 mg/kg bw/day
- Dose / conc.:
- 263 mg/kg bw/day
- No. of animals per sex per dose:
- 25-31 females per group were mated; number of pregnants: 21/23/24/20 for 2.6/12/56/263 mg/kg bw/day
- Control animals:
- yes, concurrent vehicle
- other: positive control animals included (Aspirin 150 mg/kg bw/day)
- Details on study design:
- Sex: female
Examinations
- Maternal examinations:
- daily observation for appearance and behaviour, with particular attention to food consumption and weight, in order to rule out any abnormalities with may have occurred as a result of anorexic effects in the pregnant female animal. Body weights were recorded on days 0, 6, 11, 15, and 17 of gestation.
- Ovaries and uterine content:
- On day 17 all dams were subjected to Caesarean section under surgical anesthesia, and the numbers of implantation sites, resorption sites, and live and dead fetuses were recorded. The urogenital tract of each dam was examined in detail for anatomical normality.
- Fetal examinations:
- body weights of life and dead fetuses were recorded; body weights of live pups were recorded; all fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations. The remaining two/thirds were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- no effect on nidation
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- see Table 1
- Description (incidence and severity):
- see Table 1
- Description (incidence and severity):
- see Table 1
- Description (incidence and severity):
- see Table 1
- Description (incidence and severity):
- see Table 1
- Changes in pregnancy duration:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 263 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: highest dose tested
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- see Table 2
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- see Table 2
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- see Table 3
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 263 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
The administration of up to 263 mg/kg bw/day of the compound to pregnant mice for 10 consecutive days had no effect on nidation or on maternal or fetal 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 maternal toxicity observed. The results were not evaluated statistically, but inspection of the tables shows no effects in the treated groups vs. control.
Table 1: maternal data
vehicle control animals | positive control animals* | 2.6 mg/kg bw | 12 mg/kg bw | 56 mg/kg bw | 263 mg/kg bw | |
pregnants |
21 | 21 | 21 | 23 | 24 | 20 |
died or aborted | 0 | 0 | 0 | 0 | 0 | 0 |
corpora lutea no. | 307 | 331 | 315 | 293 | 332 | 364 |
corpoa lutea/dam mated | 12.3 | 11.4 | 12.6 | 12.7 | 13.3 | 11.7 |
live litters no. | 21 | 19 | 20 | 22 | 24 | 20 |
implant sites no. | 242 | 210 | 250 | 252 | 289 | 235 |
implant sites average/dam | 11.4 | 10.4 | 11.3 | 10.6 | 11.1 | 11.5 |
resorptions no. | 9 | 32 | 27 | 22 | 12 | 16 |
dams with 1 or more sites resorbed | 8 | 10 | 11 | 8 | 10 | 6 |
live fetuses no. | 229 | 178 | 221 | 229 | 275 | 214 |
live fetuses average/dam | 10.9 | 8.48 | 10.5 | 9.96 | 11.5 | 10.7 |
dead fetuses | 4 | 0 | 2 | 1 | 2 | 5 |
dams with 1 or more dead | 4 | 0 | 2 | 1 | 2 | 5 |
% partial dead | 19.1 | 0 | 9.52 | 4.35 | 8.33 | 25.0 |
* positive control Aspirin 150 mg/kg bw/day
Table 2: fetal data
vehicle control animals | positive control animals* | 2.6 mg/kg bw | 12 mg/kg bw | 56 mg/kg bw | 263 mg/kg bw | |
live fetuses no. | 229 | 178 | 221 | 229 | 275 | 214 |
average fetal body weight (g) | 0.87 | 0.84 | 0.90 | 0.90 | 8.33 | 25.0 |
sex ratio (m/f) | 1.04 | 0.91 | 0.55 | 0.68 | 1.23 | 0.98 |
* positive control Aspirin 150 mg/kg bw/day
Table 3: fetal skeletal findings
vehicle control animals | positive control animals* | 2.6 mg/kg bw | 12 mg/kg bw | 56 mg/kg bw | 263 mg/kg bw | |
live fetuses examined (at term)/no. of litters |
158/21 | 126/19 | 152/20 | 161/22 | 192/24 | 149/20 |
sternebrae incomplete oss. | 95/20 | 47/13 | 71/19 | 91/20 | 129/23 | 116/19 |
sternebrae missing | 20/7 | 24/9 | 18/9 | 23/9 | 18/8 | 36/10 |
ribs wavy | 0 | 1/1 | 0 | 0 | 0 | 0 |
ribs more than 13 | 18/9 | 18/10 | 43/14 | 17/10 | 24/12 | 17/7 |
vertebrae incomplete oss. | 8/3 | 16/8 | 3/2 | 0 | 2/2 | 14/5 |
skull incomplete closure | 2/1 | 0 | 0 | 0 | 0 | 0 |
extremities incomplete oss. | 8/3 | 17/8 | 3/3 | 9/5 | 1/1 | 13/5 |
hyoid, missing | 57/16 | 36/14 | 41/15 | 50/14 | 45/16 | 44/14 |
hyoid, reduced | 23/13 | 18/9 | 21/12 | 35/16 | 41/16 | 31/15 |
pelvic bones, incomplete | 0 | 0 | 0 | 2/1 | 0 | 1/1 |
* positive control Aspirin 150 mg/kg bw/day
Applicant's summary and conclusion
- Executive summary:
The administration of up to 263 mg/kg bw/day adipic acid by gavage to groups of 20 to 24 pregnant mice from gestation days (gd) 6 - 15 (10 consecutive days) had no effect on nidation or on maternal or fetal 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. Thus, neither embryo- or fetotoxicity nor teratogenicity was observed. 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.
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