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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.