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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:
weight of evidence
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
- Batch: A 7013 sampling date 19.08.2009
- Test item name as stated in the study report: 2-Acetone, condensation product with phenol
- Appearance: brown solid

In vitro test system

Test system:
human skin model
Source species:
human
Cell source:
other: in vitro reconstructed human epidermis EST-1000 (Cell Systems, St. Katharinen, Germany)
Details on test system:
The model used for this study has a functional statum corneum with an underlying layer of living cells. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.
Control samples:
yes, concurrent vehicle
yes, concurrent positive control
Amount/concentration applied:
30 mg per insert, moistened with 50 µL physiological saline
Duration of treatment / exposure:
20 min
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
1.83
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Bisphenolharz spezial was characterised by a significant impact on cell viability. Thus, Bisphenolharz spezial should be regarded as skin irritant according to UN GHS category 2.

 Sample No.  Test item  % Viability
 1 -3  Negative Control (0.9% NaCl)  100.00
 4 -6  Positive Control (0.5% SDS)  1.71
 7 -9  Bisphenolharz spezial  1.83

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Executive summary:

The test item was tested in an in vitro skin irritation test on reconstructed human epidermis (EST-1000) according to EU method B.46 (Skin Irritation). The EST-1000 model provides a functional stratum corneum with an underlying layer of living cells. The test item was applied pure as powder, moistened with physiological saline, for 20 min followed by a 42 hour incubation time. Cell viability was determined by the MTT method. The test item was characterised by a significant impact on cell viability in this in vitro skin irritation study. Cell viability was reduced to 1.83% compared to negative control cultures (100%). Thus, the test item should be regarded as skin irritant according to UN GHS category 2.