Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

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

Test material

Constituent 1
Reference substance name:
2-Acetone, condensation product with phenol
EC Number:
Cas Number:
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
2-Acetone, condensation product with phenol
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:
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:

Results and discussion

In vitro

Irritation / corrosion parameter:
% tissue viability
Vehicle controls validity:
Positive controls validity:

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
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.