Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

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:
solid: crystalline
Specific details on test material used for the study:
Supplier: Changzou Foreign Trade Corp.Batch No.: 0041A25 (20141211)Physical state: solid substance, crystalline powderColour: whiteStorage: in a cool, dry place, protected from light

In vitro test system

Test system:
human skin model
Source species:
human
Details on test system:
EpiSkinTM Small Model (EpiSkinTMSM), manufactured by EPISKIN SNC Lyon, France, is a three-dimensional human epidermis model. Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 mg of the test item was applied evenly onto the skin.
Duration of treatment / exposure:
The plates with the treated epidermis units were incubated for the exposure time of 15 minutes (± 0.5 min) at room temperature.
Duration of post-treatment incubation (if applicable):
After rinsing the units were placed into the plate wells with fresh pre-warmed “maintenance medium” (2 mL/well) below them and then incubated for 42 hours (± 1h) at 37°C in an incubator with 5 % CO2.
Number of replicates:
Three replicates were used for the test item and controls respectively.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
65
Vehicle controls valid:
not examined
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item AMIDINOTHIOUREA (CAS No. 2114-02-5) is considered to be non-irritant to skin and is therefore not classified (UN GHS No Category).