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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

no data available

Additional information

There were no specific experimental studies concerning fertility available. In a subchronic oral toxicity study (Greco et al., 1990), male and female rats were fed with a pellet diet for 180 days (rats: 500 or 1000 mg/kg nominal). No adverse effects on reproductive organs or tissues were reported as well as normal number of pregnancies, live births, and normal offspring were observed. In conclusion, disodium sebacate is very unlikely to impair reproductive capacity of both sexes. Therefore, no fertility study was proposed, since it was not assumed to reveal new information regarding toxicological effects on fertility.

Effects on developmental toxicity

Description of key information

No maternal or embryotoxic/teratogenic effects were observed at 500 mg/kg nominal diet in rats (Greco, 1990).


Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified
Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Housing: separate
- Diet: ad libitum
- Water: ad libitum

Route of administration:
oral: feed
Vehicle:
other: pellet diet
Details on exposure:
DIET PREPARATION
- Mixing appropriate amounts with: pellet diet

VEHICLE
- Concentration in vehicle: 500 mg/kg
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/20
- Length of cohabitation: 10 days

- Any other deviations from standard protocol: cohouse in a metabolic cage

Duration of treatment / exposure:
Group 1: 10 animals: day 1 to 19 of pregnancy
Group 2: 10 animals: day 1 to 19 of pregnancy, plus 3 months, including the suckling period
Frequency of treatment:
continuously
Dose / conc.:
500 other: mg/kg nominal in diet
No. of animals per sex per dose:
10 animals per group
Control animals:
yes
Maternal examinations:
POST-MORTEM EXAMINATIONS: Yes
- Organs examined: Uterus, ovaries, placenta
Ovaries and uterine content:
The ovaries and uterine content was examined after termination
Fetal examinations:
- External examinations: Yes
Clinical signs:
no effects observed
Gross pathological findings:
no effects observed
Number of abortions:
no effects observed
Changes in number of pregnant:
no effects observed
Details on maternal toxic effects:
Both macroscopic and microscopic features of the uterus, placenta and ovaries appeared normal.
Key result
Dose descriptor:
NOEL
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
Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
no effects observed
External malformations:
no effects observed
Details on embryotoxic / teratogenic effects:
No abortions or fetal malformations were observed in the animals sacrificed on day 19 of pregnancy. No still-born animals were found in the treatment groups and the newborns were free from malformations.
Key result
Dose descriptor:
NOEL
Effect level:
>= 500 mg/kg bw/day
Basis for effect level:
fetal/pup body weight changes
changes in litter size and weights
external malformations
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no

There was no effect found on the number of pregnancies, the macroscopic and microscopic features of uterus, placenta and ovaries. The number of live births and normal offsprings from the dosed groups was comparable to control and no teratogenic effects were observed.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Additional information

In a teratogenicity study, female rats and rabbits were fed with disodium sebacate 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. A NOEL of > 500 mg/kg bw/day was determined in rats. As a result the substance is not considered to be classified for toxicity for reproduction under Regulation (EC) No. 1272/2008, as amended for the ninth time in Regulation (EC) No. 2016/1179.

Additional information