2-Acetone, polymer with phenol

Skin irritation / corrosion

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

Guideline:

other: EU Method B.46 (Skin Irritation)

Deviations:

yes

Remarks:

As amended for in vitro study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Acetone, polymer with phenol

EC Number:

500-086-4

EC Name:

2-Acetone, polymer with phenol

Cas Number:

35238-34-7

Molecular formula:

(C6H6O.C3H6O)x

IUPAC Name:

2-Propanone, polymer with phenol

Constituent 2

Reference substance name:

: 2-Acetone polymer with phenol

IUPAC Name:

: 2-Acetone polymer with phenol

Constituent 3

Reference substance name:

BPA-Tars

IUPAC Name:

BPA-Tars

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.