Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08/05/2018-11/05/2018
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)
Version / remarks:
Reconstructed Human Epidermis Test Method - adopted in 2013
Method followed: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) with Reconstructed Human
Epidermal Model
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
They have different version of synthesis based on scale (small, medium, large) There is differences between dirrerent scales are related to materials physical properties.
Specific details on test material used for the study:
Q0002-1701

In vitro test system

Test system:
other: reconstructed Human Epidermal Model.
Vehicle:
not specified
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 85.2
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
According to the EU and GHS classification (R38/Category 2 or no label), an irritant is predicted if the mean relative tissue viability of three individual tissues exposed to the test substance is reduced below 50% of the mean viability of the negative controls.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to results obtained from this test implementation, the viability of Reconstructed human epidermal model is > 50%. The product: UPSALITE Q0002-1701 is classified as: NI (Not Irritant)/not required classification.