2-Propanone, polymer with phenol

Skin irritation / corrosion

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

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Acetone, condensation product with phenol

EC Number:

931-252-8

Cas Number:

35238-34-7

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

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:

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.