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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:
09.11.2017 - 27.03.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
other: EpiDermTM (EPI-200, Lot no. 25876) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic
Details on test animals and environmental conditions:
EpiDerm™ is cultured from normal human keratinocytes.

Test system

Amount / concentration applied:
30 µl
Duration of treatment / exposure:
Quality control 4 h (± 15 min) (Triton X-100, 1 % solution)
Positive control 60 min (± 1 min) (SDS 5 % solution)
Negative control 60 min (± 1 min) Dulbecco's phosphate buffered saline (D-PBS)
Test substance 60 min (± 1 min) undiluted
Observation period:
after washing process post incubation period of 42 h
Number of animals:
The test was performed in triplicate

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 29
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Test substance: mean viability 29.0 %

Negative control: mean viability 100 %

Positive control: mean viability 7.2 %

Applicant's summary and conclusion

Interpretation of results:
other: Irritant (I) (GHS Cat. I or Cat. II)
Conclusions:
Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (in triplicate)
resulted in a mean cell viability of 29.0 % when compared to the corresponding negative conrol. According to the evaluation scheme of OECD test
guideline 439 the test substance has to be predicted as irritating to the skin.
Executive summary:

The purpose of this study was to determine cytotoxic properties of Neodecanoic acid, tin(2+) salt (2:1) to skin cells, which might lead to irritation of human skin, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.

Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed

as relative percentage of viability of the negative control-treated tissues.

Neodecanoic acid, tin(2+) salt (2:1) was applied as liquid test item topically undiluted to the model skin surface. D-PBS was used as the negative control. 5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item. An exposure time of

60 minutes was employed followed by a 42-hour post-treatment incubation period in fresh medium.

The mean viability of cells exposed to Neodecanoic acid, tin(2+) salt (2:1) was 29.0% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of ≤ 50%. Neodecanoic acid, tin(2+) salt (2:1) was

considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS category 1 or 2 (H314 or H315).