Registration Dossier
Registration Dossier
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EC number: 203-672-5 | CAS number: 109-43-3
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Method not validated.
Data source
Reference
- Reference Type:
- publication
- Title:
- Cytocompatibility and Viscoelastic Properties of Phthalate Ester-free Tissue Conditioners
- Author:
- Hashimoto, Y. and Nakamura, M.
- Year:
- 2 004
- Bibliographic source:
- Dental Materials Journal 23(3): 412-418
Materials and methods
- Principles of method if other than guideline:
- E-screen assay: The assay uses breast-tumor derived MCF-7 cells to compare the ability of chemicals to mimic growth stimulation by estradiol using Sulforhodamin B assay (SRB).
TESTSKIN, LSE system: Co-culture of human dermal fibroblasts and keratinocytes, cytotoxicity was assessed with WST (tetrazolium salt) assay (LSE possesses biosynthetic properties that approximate their in vivo counterparts). - GLP compliance:
- not specified
- Type of method:
- in vitro
- Endpoint addressed:
- other: endocrine disruption and cytotoxicity on fibroblasts/keratinocytes
Test material
- Reference substance name:
- Dibutyl sebacate
- EC Number:
- 203-672-5
- EC Name:
- Dibutyl sebacate
- Cas Number:
- 109-43-3
- Molecular formula:
- C18H34O4
- IUPAC Name:
- dibutyl sebacate
- Details on test material:
- - Name of test material (as cited in study report): Di-n-butal sebacate DBS
- Lot/batch No.: N-2020
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: MCF-7 cells and TESTSKIN (LSE)
Administration / exposure
- Route of administration:
- other: cell culture medium and living skin equivalent
- Vehicle:
- ethanol
- Duration of treatment / exposure:
- E-screen: 144 hours
TESTSKIN, LSE system: 6 and 24 hours - Frequency of treatment:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
85 % (weight percentage)
Basis:
nominal conc.
- No. of animals per sex per dose:
- not applicable
Test was performed once in triplicates. - Control animals:
- other: conrol cultures: cell culture medium containing 0.1% DMSO; control LSE: Saline
Results and discussion
- Details on results:
- Although the positive control, bisphenol A, stimulated MCF-7 cell growth, the test substance did not significantly enhance the growth compared to the negative control.
In the LSE-system (TESTSKIN) cell viability was not affected by the 6-hour treatment with the test substance.
Applicant's summary and conclusion
- Conclusions:
- The present study showed that DBS as a main plasticiser did not show estrogenic activity and did only exert a weak cytotoxicity after 24 hours and is therefore not likely to cause any acute oral toxicity or irritate the skin.
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