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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16/05/2017-18/06/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Qualifier:
according to
Guideline:
other: Council regulation 440/2008, Method B.40 BIS:"In vitro skin Corrision:Human skin model Test", May 30, 2008
Qualifier:
according to
Guideline:
other: MatTek Corporation protocol for: In Vitro EpiDerm TM Skin Corrosion Test (EPI-200-SCT) For Use with MatTek Corporation's reconstructed Human Epidermal Model EpiDerm; Version 07/11/2014.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- batch No.of test material: 78-242-15
- Expiration date of the batch: 01/02/2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Stability under test conditions: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was applied undiluted. 50 µL of the test item was dispensed directly atop the EpiDerm TM tissue. The test item was spread to match size of the tissue. A nylon mesh was used as spreading aid.

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from multiple donors

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
after 3 minutes
Value:
>= 50
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not specified
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
after 60 minutes
Value:
>= 15
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not specified

Any other information on results incl. tables

The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).

The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no corrosive effects. the test item is classified as "non-corrosive".
Executive summary:

In the present study the skin corrosivity potential of the test item was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDermÔ, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.

The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).

The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.