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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
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: Acceptable published study, basic data given.

Data source

Reference
Reference Type:
publication
Title:
Toxicity of butyl stearate, dibutyl sebacate, dibutyl phthalate, and methoxyethyl oleate
Author:
Smith, C.C.
Year:
1953
Bibliographic source:
Archives of Industrial Hygiene and Occupational Medicine, 1953

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 20 males and 20 female rats were dosed with the test substance via the diet for 10 weeks and then mated. Date of parturition and number of young in each litter were recorded. Litters were weaned 21 days port partum, and the weight of the weanlings was determined. 24 male and 24 female weanlings were selected at random and for the next 21 days these young were fed the same diet as had been ingested by their parents. Diet intakes and body weights were recorded daily. 21 Days after weaning, the rats were killed and autopsies were performed.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl sebacate
EC Number:
203-672-5
EC Name:
Dibutyl sebacate
Cas Number:
109-43-3
Molecular formula:
C18H34O4
IUPAC Name:
1,10-dibutyl decandioiate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: (P) 5-6 weeks
- Weight at study initiation: Control group: (F1) Males: 44 ± 8 g; Females: 43 ± 9 g; Treatment group: (F1) Males: 38 ± 5 g; Females: 36 ± 5 g

Administration / exposure

Route of administration:
oral: feed
Details on mating procedure:
After successful mating each pregnant female was caged: Pregnant females were transferred to individual breeding cages.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
(P) Males and Females: 10 weeks before mating
(F1) 24 males and 24 females were chosen at random and 21 days post partum fed the same diet
Frequency of treatment:
Parental animals:
Daily for 10 weeks

F1 animals:
Daily for 21 days post partum
Details on study schedule:
- Parental animals were fed diets containing 6.25% test substance for 10 weeks and mated. A control group of 12 male and 12 female animals of the same age were fed the basal ratio for 10 weeks and mated.
- Litters were weaned 21 days post partum.
- 24 male and 24 female litters were chosen at random and 21 days post partum fed the same diet as had been ingested by their parents.
Doses / concentrations
Remarks:
Doses / Concentrations:
6.25%
Basis:
nominal in diet
corresponding to about 6000 mg/kg bw/day
No. of animals per sex per dose:
Parental animals:
Control group: 12 males and 12 females
Treatment group: 20 males and 20 females

F1 animals:
Treatment group: 24 males and 24 females
Control animals:
yes, plain diet

Examinations

Parental animals: Observations and examinations:
Examination of parental animals was focused on fertility.
Litter observations:
The following parameters were examined in [F1] offspring: number and sex of pups, litter size, survival of offspring, body weight (daily), weight gain.
Postmortem examinations (parental animals):
Not specified.
Postmortem examinations (offspring):
The F1 offspring were sacrificed 21 days after weaning and and were subjected to postmortem examinations.

Results and discussion

Results: P0 (first parental generation)

Reproductive function / performance (P0)

Reproductive performance:
no effects observed

Results: F1 generation

Details on results (F1)

Administration of the test substance resulted in a retarded growth during the preweaning and postweaning periods. However, no gross pathological changes were found among young rats killed at the end of the 12-day postweaning period.

Effect levels (F1)

open allclose all
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 6 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects were noted with respect to fertility.
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 6 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Groups of 20 males and 20 female rats were dosed with the test substance via the diet for 10 weeks and then mated. Date of parturition and number of young in each litter were recorded. Litters were weaned 21 days post partum, and the weight of the weanlings was determined. 24 male and 24 female weanlings were selected at random and for the next 21 days these young were fed the same diet as had been ingested by their parents. Diet intakes and body weights were recorded daily. 21 Days after weaning, the rats were killed and autopsies were performed.

Dibutyl sebacate in dietary concentrations of 6.25% had no adverse effect on fertility or the number of viable young in the litter, however growth of young was slightly but significantly retarded.