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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:
key study
Study period:
19 January 2011 to 16 August 2011
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 431 In Vitro Skin Corrosion: Human Skin Model Test and Method B.40 BIS of Commission Regulation (EC) No 440/2008
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Stability under test conditions: not reported
- Storage condition of test material: At room temperature at about 20 °C

Test animals

Species:
other: EpiDerm tissues (three-dimensional human skin model)
Details on test animals and environmental conditions:
No test animals were used.
EpiDerm tissues were supplied by MatTek Corporation, Ashland, Massachusetts, USA and stored refrigerated. Tissues were transferred to 6-well plates with the assay medium 90 minutes before starting the assay.

Test system

Type of coverage:
other: Not applicable
Preparation of test site:
other: Not applicable
Vehicle:
other: Not applicable - no vehicle used
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 40 mg
- Concentration (if solution): Undiluted test material
Duration of treatment / exposure:
Contact time of 3 minutes or 1 hour
Observation period:
Incubated at 37°C for 3 hours
Number of animals:
No animals were used on this test.
Four EpiDerm tissues were used per test substance, negative and positive control
Details on study design:
APPLICATION OF TEST AND CONTROL MATERIALS:
Immediately prior to treatment was intitiated the assay medium was replaced.
Approximately 40 mg of solid test substance was placed onto the tissue and moistened with 25 µL water to ensure good contact with the tissue surface. Further tissues were treated with 40 mL distilled water (negative control) and with 40 mL 8N potassium hydroxide (positive control).
Duplicate tissues were used for each contact time (3 minutes or 1 hour).
After the 3 minute or 1 hour contact periods, the tissues were washed with phosphate buffered saline (PBS) to remove residual material.

CELL VIABILITY MEASUREMENTS:
The assay medium was replaced with 300 mL of 1 mg/mL MTT-medium and tissues were incubated for 3 hours at 37°C. After incubation, the tissues were washed with PBS and formazan was extracted with 2 mL isopropanol overnight, without shaking.
The optical density of the extracted formazan was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as a percentage of the mean of the negative control tissue. Skin corrosivity potential of the test article was classified according to the remaining cell viability obtained after test article treatment with either of the two treatment times.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
105
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 minutes. Reversibility: other: Not measured. (migrated information)
Irritation / corrosion parameter:
other:
Value:
101
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 1 hour. Reversibility: other: Not measured. (migrated information)

Any other information on results incl. tables

Skin corrosion assay; cell viability measurements

3 minute treatment

Substance

Tissue replicate

OD540

Mean

Tissue mean

% difference between Rep’s

% Relative survival

Aliquot 1

Aliquot 2

Aliquot 3

Negative control

A

1.521

1.527

1.527

1.525

1.617

10.8

100

B

1.710

1.709

1.708

1.709

Test article

A

1.662

1.777

1.793

1.744

1.702

-5.0

105

B

1.602

1.688

1.692

1.660

Positive control

A

0.418

0.428

0.426

0.424

0.425

-0.4

26

B

0.424

0.425

0.428

0.426

        1 hour treatment

Substance

Tissue replicate

OD540

Mean

Tissue mean

% difference between Rep’s

% Relative survival

Aliquot 1

Aliquot 2

Aliquot 3

Negative control

A

1.854

1.852

1.844

1.850

1.771

-9.3

100

B

1.711

1.684

1.683

1.693

Test article

A

1.762

1.767

1.752

1.760

1.791

3.4

101

B

1.823

1.841

1.804

1.823

Positive control

A

0.224

0.238

0.228

0.230

0.239

-8.0

13

B

0.247

0.251

0.246

0.248

 

Applicant's summary and conclusion

Interpretation of results:
other: Not corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was considered not to be corrosive to the invitro skin testing model, EpiDerm.
Executive summary:

The result indicates that the substance should be non-corrosive to skin. Without furtherin vivodata the result has to be considered as inconclusive regarding classification.