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Toxicological information

Skin irritation / corrosion

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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:
2011
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

Constituent 1
Chemical structure
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

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 .