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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: in vitro skin irritation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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:
other: EU Method B.46 (Skin Irritation)
Deviations:
yes
Remarks:
As amended for in vitro study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

In vitro test system

Test system:
human skin model
Source species:
human
Details on animal used as source of test system:
in vitro reconstructed human epidermis EST-1000 (Cell Systems, St. Katharinen, Germany)
Justification for test system used:
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.
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent vehicle
yes, concurrent positive control
Amount/concentration applied:
30 mg test substance per insert plus 50 µl 0.9% NaCl to moisten and ensure good contact with the skin (three replicates)
Duration of treatment / exposure:
20 min
Duration of post-treatment incubation (if applicable):
42 hours post-treatment incubation period
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 1.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
2-Acetone polymer with phenol (BPA-Tars) was characterised by a significant impact on cell viability reducing survival to 1.8% relative to control. Thus, BPA-Tars should be regarded as skin irritant according to UN GHS category 2.

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
Conclusions:
BPA-Tars induced a relative cell viability of 1.8%. Therefore, it is considered a skin irritant, Category 2.
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) as amended. The EST-1000 model provides a functional stratum corneum with an underlying layer of living cells. The test item, 2 -Acetone polymer with phenol (BPA-Tars) was applied as pure powder, moistened with physiological saline, for 20 min followed by a 42 hour incubation time. Cell viability was determined by the MTT reduction method. BPA-Tars was characterised by a significant impact on cell viability in this in vitro skin irritation study. Cell viability was reduced to 1.8% compared to negative control cultures (100%). Thus, BPA-Tars should be regarded as skin irritant according to UN GHS category 2.