Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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

Data source

Reference Type:
study report

Materials and methods

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), dosed on day 9,  was used as a positive control.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Adipic acid
EC Number:
EC Name:
Adipic acid
Cas Number:
Molecular formula:
Hexanedioic Acid
Details on test material:
IUCLID4 Test substance: other TS: purity not specified

Test animals

other: Dutch-belted

Administration / exposure

Route of administration:
oral: gavage
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  with 0.3 ml of diluted semen from a proven donor buck.
Duration of treatment / exposure:
13 d
Frequency of treatment:
6.-18. gestation day, daily
Duration of test:
all animals were subjected to cesarean section on GD 29
Doses / concentrations
Doses / Concentrations:
0, 2.5, 12, 54, 250 mg/kg bw/day

No. of animals per sex per dose:
10-14 females per dose
Control animals:
Details on study design:
Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Key result
Dose descriptor:
Effect level:
>= 250 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Maternal abnormalities

Key result
no effects observed

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
Effect level:
>= 250 mg/kg bw/day
Based on:
test mat.
not specified
Basis for effect level:
other: no adverse effects were found at the highest dose level of 250 mg/kg bw/day.

Fetal abnormalities

Key result
no effects observed

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

The administration of up to 250 mg/kg bw/day of the compound to pregnant rabbits for 13 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 difference between treatment and control groups were found for corpora lutea, implantations, total no. of resorptions, total no. of fetuses, total no. of live litters and fetal weights. No maternal toxicity observed. The results were not evaluated statistically, but inspection of tables shows no effects in the treated groups vs. control.


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 at the highest doses tested, a dose below the limit dose of 1000 mg/kg bw.