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Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Toxicity of disodium sebacate
Author:
Greco A.V., Mingrone G., Mastrimattei A. E., Finotti E., Castagneto M.
Year:
1990
Bibliographic source:
DRUGS EXPTL. CLIN . RES. XVI (10) 531-536

Materials and methods

Principles of method if other than guideline:
Following a 10 day mating period, each female animal (total of 20 animals) was placed in a single cage and fed a pellet diet containing the test substance or no test substance in the case of the controls for 25 days after which 10 animal were sacrificed. Treatment of the remaining 10 female animals was continued for another 3 months including the period of suckling. At the end, the animals were also sacrificed. Fetuses and reproduction organs of all animals (uterus, placenta, ovaries) were weighed post mortem and examined macroscopically as well as histologically.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Disodium sebacate (DSS)
IUPAC Name:
Disodium sebacate (DSS)
Constituent 2
Reference substance name:
Disodium sebacate
EC Number:
241-300-3
EC Name:
Disodium sebacate
Cas Number:
17265-14-4
IUPAC Name:
disodium sebacate

Test animals

Species:
rabbit
Strain:
other: New Zealand

Administration / exposure

Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: pellet diet
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
The male and female animals were cohoused at a ratio of 1 male to 20 females for 10 days in a metabolic cage.
Duration of treatment / exposure:
Group 1: 10 animals: day 1 to 25 of pregnancy,
Group 2: 10 animals: day 1 to 25 of pregnancy plus 3 months
Frequency of treatment:
continuously
Doses / concentrations
Remarks:
Doses / Concentrations:
1000 mg/kg
Basis:
nominal in diet
No. of animals per sex per dose:
10 females per group
Control animals:
yes

Examinations

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

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
Both macroscopic and microscopic features of the uterus, placenta and ovaries appeared normal.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No abortions or fetal malformations were observed in the animals sacrificed on day 25 of pregnancy. No still-born animals were found in the DSS groups and the newborns were free from malformations.

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Basis for effect level:
other: teratogenicity
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Basis for effect level:
other: fetotoxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

No effect was 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, no teratogenic effect was observed.

Applicant's summary and conclusion

Conclusions:
No teratogenic effect was observed on animals after oral adminidtration of disodium sebacate. Based on a read across (category approach), undecanedioic acid is not expected as well to show teratogenic effects.