Registration Dossier
Registration Dossier
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EC number: 208-816-0 | CAS number: 542-52-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- July 2012
- Qualifier:
- according to guideline
- Guideline:
- other: New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment No. 203
- Version / remarks:
- July 2014
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dibutyl carbonate
- EC Number:
- 208-816-0
- EC Name:
- Dibutyl carbonate
- Cas Number:
- 542-52-9
- Molecular formula:
- C9H18O3
- IUPAC Name:
- dibutyl carbonate
- Test material form:
- liquid
- Remarks:
- colorless, clear
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B16Q060201
- Purity test date: 2017-01-02
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Other:
pH value: 5
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200 (MatTek)
- Tissue batch number(s): 23388
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25min at room temperature, 35min in the incubator at 37°C
- Temperature of post-treatment incubation (if applicable): 37°C (app. 42h)
REMOVAL OF TEST MATERIAL AND CONTROLS
The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the surface of each tissue was carefully dried with a sterile cotton swab.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3h
- Wavelength: 570nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.4 (hc: 1-3)
- Barrier function: 6.73h (hc: 4.8 - 8.7h)
- Contamination: sterile - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30µL undiluted
- Duration of treatment / exposure:
- 1h
- Duration of post-treatment incubation (if applicable):
- app. 42h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 96.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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