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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer reviewed, test procedure in accordance with generally accepted scientific standards with acceptabele restrictions: poor documentation

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Principles of method if other than guideline:
See publication
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Disodium sebacate
EC Number:
241-300-3
EC Name:
Disodium sebacate
Cas Number:
17265-14-4
IUPAC Name:
disodium sebacate
Details on test material:
decanedioic acid, disodium salt
1,8-octanedicarboxylic acid, disodim salt

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: feed
Details on mating procedure:
Before treatment, one group of twenty female rabbits were palced into metabolic cages together with a male rat; after 10 days each female was put in a single cage.
Duration of treatment / exposure:
Animals were fed a pellet diet correspondig to a daily dose of 1000 mg/kg bw (4.1 mmol/kg bw/day).
Doses / concentrations
Remarks:
Doses / Concentrations:
1000
Basis:
nominal in diet
No. of animals per sex per dose:
10
Control animals:
yes, plain diet

Examinations

Maternal examinations:
weight of uterus and placenta
Ovaries and uterine content:
abortions
Fetal examinations:
weight and number of fetuses, malformations

Results and discussion

Results: maternal animals

Maternal developmental toxicity

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

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
935 mg/kg bw/day (nominal)
Based on:
other: calculated for dodecanedioic acid
Basis for effect level:
other: developmental toxicity

Results (fetuses)

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

Details on embryotoxic / teratogenic effects:
no abortions and no fetal malformations and no still born animals were observed

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
There was no indication of developmental toxicity at a limit dose level of 1000 mg/kg bw/d of disodium sebacate (4.1 mmol/kg bw/day) in rabbits.
Executive summary:

In a limit dose study, a group of 10 female New Zealand rabbits were mated and received a diet corresponding to a dose of 1000 mg/kg bw/day of disodium sebacate (4.1 mmol/kg bw/day) until sacrifice of day 25 of pregnancy. A control group received plain diet. No abortions, still born animals or malformations were observed upon treatment.