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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 February 2013 to 9 February 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid
Details on test material:
- Name of test material (as cited in study report): Bis(2-ethylhexyl) Succinate
- Storage condition of test material: In a sealed container, at room temperature, in the dark

Test animals

Details on test animals and environmental conditions:
EpiDerm™: Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum supplied by MatTek Corporation, Ashland, Massachusetts, USA.

Test system

Amount / concentration applied:
40 µL mg of the test material was applied topically.
Duration of treatment / exposure:
3 and 60 minutes.
Observation period:
3 hours
Number of animals:
Not applicable

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: OD570
Basis:
mean
Remarks:
duplicate tissues
Time point:
other: 60 minutes
Score:
1.67
Max. score:
1.821
Irritation parameter:
other: % survival
Basis:
mean
Remarks:
duplicate tissues
Time point:
other: 60 minutes
Score:
16.6
Max. score:
100
Irritant / corrosive response data:
Skin viability after a three minute or one hour exposure to the test material was 93 % and 89 %, respectively.

Skin viability after a three minute or one hour exposure to the positive control article was 18 % and 11 %, respectively, demonstrating appropriate performance of the assay.

Any other information on results incl. tables

Table 1: Three Minute Exposure Period

Substance

OD570

Mean

Tissue mean

% viability

% survival

Negative

2.007

2.015

2.041

2.021

1.854

16.5

100

Negative

1.669

1.686

1.705

1.687

Test material

1.597

1.593

1.625

1.605

1.732

13.6

93

Test material

1.0853

1.862

1.860

1.859

Positive

0.354

0.342

0.361

0.352

0.330

12.7

18

Positive

0.307

0.304

0.311

0.307

 

 

Table 2: One Hour Exposure Period

Substance

OD570

Mean

Tissue mean

% viability

% survival

Negative

1.957

1.924

1.923

1.935

1.879

5.7

100

Negative

1.821

1.794

1.857

1.824

Test material

1.525

1.511

1.519

1.518

1.670

16.6

89

Test material

1.827

1.810

1.826

1.821

Positive

0.177

0.184

0.174

0.178

0.200

19.3

11

Positive

0.225

0.209

0.230

0.221

 

Applicant's summary and conclusion

Interpretation of results:
other: Irritancy cannot be assessed with this method.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the test material was considered not to be corrosive to the skin in the in vitro skin model EpiDerm™.
Executive summary:

The potential of the test material to be corrosive to skin was investigated in vitro, in a GLP study which was conducted in accordance with the standardised guidelines OECD 431 and EU Method B.40 bis.

During the study, duplicate EpiDerm™ inserts were treated with test material, distilled water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.

Skin viability after a three minute or one hour exposure to the test material was 93 % and 89 %, respectively.

Skin viability after a three minute or one hour exposure to the positive control article was 18 % and 11 %, respectively, demonstrating appropriate performance of the assay.

Under the conditions of the study, the test material was considered not to be corrosive to the skin in the in vitro skin model EpiDerm™.