Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction

Developmental toxicity / teratogenicity

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

Test material information

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.