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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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Principles of method if other than guideline:
EPISKIN Skin Irritation Test-42 Hours
GLP compliance:
yes

Test material

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

Test animals

Species:
human
Strain:
other: Three dimensional human skin model
Details on test animals and environmental conditions:
The test involves the application of the test substance for 15 minutes to the EPISKIN threedimensional human skin model. The model consists of normal, human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen. After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum has formed. The epidermis surface area supplied is 0.38 cm^2. The EPISKIN kits include assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar.

Test system

Type of coverage:
other: In vitro
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test substance, positive and negative controls were in liquid form and were applied by dispensing a volume of 10 µl over each tissue using a positive displacement pipette.
Duration of treatment / exposure:
Exposure over 15 minutes.
Number of animals:
N/A

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
14.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: +/- 2.7 %

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In vitro skin irritation using the EPISKIN method gave a moderately irritating response.
Executive summary:

The skin irritation potential of the test substance was determined in vitro using the EPISKIN human epidermis model. The test substance was applied to EPISKIN human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances. The test substance elicited a mean tissue viability of 14.3 ± 2.7% and was predicted as irritant.