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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no studies on fertility available for the test substance.

However, there are studies available using the analogue substances disodium sebacate (CAS 17265-14-4) and adipic acid (CAS 124-04-9).

In the described two-years feeding study with sebacic acid in rats histopathological examination of testes, ovaries and uterus revealed no evidence of an adverse effect on the reproductive organs up to the highest tested doses (3750 mg/kg bw/day in males, 750 mg/kg bw/day in females).

Besides, there are sufficient information from subchronic studies, using disodium sebacate in rats and rabbits, to conclude that sebacic acid is very unlikely to impair reproductive capacity in both sexes, as no adverse effects after macroscopic and microscopic examination on reproductive organs or tissues were reported after exposure up to 1000 mg/kg bw/day in rats and 1500 mg/kg bw/day in rabbits.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There are no specific experimental studies concerning fertility.

However, there are studies available using the analogue substances disodium sebacate (CAS 17265-14-4) and adipic acid (CAS 124-04-9).

These information are sufficient to conclude that sebacic acid is very unlikely to impair reproductive capacity in both sexes.

In the chronic oral toxicity study, using the analogue substance sebacic acid (CAS 124-04-9), male and female rats were fed with the test substance mixed with a pellet diet for 2 years. The test substance was dosed at concentrations of 0.1, 1, 3, and 5 % (approx. 75, 750, 2250, 3750 mg/kg bw/day) for males and at 1 % (approx. 750 mg/kg bw/day) for females. No effects were observed at the histopathologic examination of the testes, ovaries and uterus. Therefore, no evidence of an adverse effect on the reproductive organs was reported.

In the subchronic oral toxicity study, using the analogue substance disodium sebacate (CAS 17265-14-4), males and females were fed with a pellet diet for 180 days (rabbits: 750 or 1500 mg/kg bw) and no adverse effects on reproductive organs or tissues were reported. In the second subchronic oral toxicity study using the same study design, rats were fed with a pellet diet for 180 days (rats: 500 or 1000 mg/kg bw) and no adverse effects on reproductive organs or tissues were reported.

Therefore, no fertility study was proposed, since it was not thought to bring new information concerning toxicological effects on fertility.

Effects on developmental toxicity

Description of key information

There are no studies available on developmental toxicity/teratogenicity for the test substance.

In two prenatal developmental toxicity studies similar to OECD 414, the analogue test substance disodium sebacate (CAS 17265-14-4) did not provoke adverse effects in rats or rabbits.

The NOAEL values were rat: >= 500 mg/kg bw/day and rabbit: >= 1000 mg/kg bw/day.

Link to relevant study records

Referenceopen allclose all

Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The justification for the type of information are discussed in the attached read-across document.
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Basis for effect level:
other: no (adverse) effects observed
Abnormalities:
no effects observed
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Basis for effect level:
other: no (adverse) effects observed
Abnormalities:
no effects observed
Developmental effects observed:
no
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The justification for the type of information are discussed in the attached read-across document.
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
> 500 mg/kg bw/day
Basis for effect level:
changes in number of pregnant
clinical signs
gross pathology
necropsy findings
number of abortions
Abnormalities:
no effects observed
Dose descriptor:
NOAEL
Effect level:
>= 500 mg/kg bw/day
Basis for effect level:
fetal/pup body weight changes
changes in litter size and weights
external malformations
Abnormalities:
no effects observed
Developmental effects observed:
no
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

In a teratogenicity study, female rats and also rabbits were fed with the sodium salt of sebacic acid (disodium sebacate, CAS 17265-14-4) after a 10 days mating period:

The females were fed with disodium sebacate during pregnancy; rats: 500 mg/kg bw up to day 19 of pregnancy; rabbits: 1000 mg/kg bw up to day 25 of pregnancy; one group each was also fed for 3 months after the mating period. No effects were found on the number of pregnancies and the macroscopic and microscopic features of uterus, placenta and ovaries. Also the number of live births and the offspring, defined either anatomically or physiologically, were similar in both treated and control animals. The teratogenic investigations showed that there was no abnormality or malformation in the progeny of both rats and rabbits.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480.. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008.

Additional information