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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:
18 September 2012 to 25 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Fully GLP compliant and in accordance with current test guidelines

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Viscous semi-solid
Details on test material:
Name: TOFA_TETA_PAA_BADGE_CGE_Adduct
CAS number: 186321-96-0
Batch number: WA520
Purity: 100%
Expiry date: 28 Feb 2014
Date of receipt: 03 Sep 2012
Storage: stored in a sealed container, at 15 to 25ºC, in the dark.

Test animals

Species:
other: Not applicable
Strain:
other: Not applicable
Details on test animals and environmental conditions:
Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum supplied by MatTek Corporation, Ashland, Massachusetts, USA. Human keratinocytes are used to construct the epithelium. Multiple layers of viable epithelial cells are present under a functional stratum corneum. The stratum corneum is multi-layered with the necessary lipid profile to produce a functional barrier. The containment properties of the model prevent the passage of material around the stratum corneum to the viable model tissue. The skin model was supplied free of contamination with bacteria, mycoplasma and fungi.

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Three tissues per test article, negative control and positive control were treated by application of 30 µL of the negative control, 30 µL of the positive control and approximately 70 mg of test article onto the surface of the tissues.
Details on study design:
The tissues were incubated at 37 ± 1ºC, 5 ± 1% Carbon Dioxide for a 35 ± 1 minute period. The plates were then removed from the incubator and placed into a sterile hood until the 60 minute treatment period was complete for each tissue.
Following treatment, substances were removed by washing the tissues. The tissues were then placed on the appropriate medium and incubated for 42 hours. The protocol stated that the incubation period would be 24 hours. This deviation from protocol was considered not to have affected the integrity or outcome of the study as this was an error in the protocol and the correct incubation period was used for this test system.
To evaluate whether residual test article was binding to the tissue, a functional check (using freeze-killed control tissue) was performed. Freeze-killed tissues were prepared by placing untreated EpiDerm constructs in the -20°C freezer overnight. The freeze-killed tissues were allowed to thaw once at room temperature and placed back in the freezer until required.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: relative group mean viability
Value:
7.2
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes treatment period. Max. score: 100.0. Reversibility: no data. (migrated information)

In vivo

Irritant / corrosive response data:
The relative group mean viability for the test article was 7.2%.
The relative group mean viability for the positive control was 4.9%.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, was considered not to be corrosive to the in vitro skin model EpiDermTM, but was considered to be an irritant to the in vitro skin model EpiDermTM SIT (EPI-200).
Executive summary:

The purpose of the study was to determine whether the test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, caused dermal corrosion or irritation. Dermal corrosion refers to the production of irreversible tissue damage in the skin following the application of a test material. Dermal irritation refers to the production of reversible inflammatory changes in the skin following the application of a test material.

An in vitro skin corrosivity assay (EpiDermTM) was initially conducted. This demonstrated that the test article did not have the potential to cause corrosion to the skin therefore an in vitro skin irritation assay (EpiDermTM SIT (EPI-200)) was conducted.

EpiDermTM SIT (EPI-200) inserts were treated with test article, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 60 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment.

The relative group mean viability for the test article was 7.2% and for the positive control was 4.9%.

The test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, was considered not to be corrosive to the in vitro skin model EpiDermTM, but was considered to be an irritant to the in vitro skin model EpiDermTM SIT (EPI-200).