Registration Dossier
Registration Dossier
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EC number: 200-164-5 | CAS number: 53-16-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (In Vitro Skin Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Estrone
- EC Number:
- 200-164-5
- EC Name:
- Estrone
- Cas Number:
- 53-16-7
- Molecular formula:
- C18H22O2
- IUPAC Name:
- estrone
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: three-dimensional human epidermis model (EPISKIN Standard Model of Skin Ethic Laboratories)
Test system
- Vehicle:
- water
- Controls:
- other: Negative control: phosphate buffered saline (PBS); Positive control: 5% (aq) Sodium dodecyl sulphate (SDS) in PBS
- Duration of treatment / exposure:
- 15 minutes exposure to the substance with an following incubation period of 42 hours at 37°C
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 99
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Estrone did not interact with MTT.
After 15 minutes of exposure to the neat substance and an additional incubation period of 42 hours the mean tissue viability of tissues treated with the test substance was 99% (negative control tissues 100%, positive control tissues 12%).
Applicant's summary and conclusion
- Interpretation of results:
- other: negative
- Conclusions:
- non-irritating
- Executive summary:
Estrone was investigated regarding its potential skin irritating properties using a SkinEthic reconstituted epidermis model (EPISKIN Standard Model). After 15 minutes of exposure to the neat substance and an additional incubation period of 42 hours cell viability of the tissues treated with the test substance was comparable to the cell viability of the negative control tissues. Therefore, estrone can be classified as non-irritating compound .
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