Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-11-23 to 2015-12-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to
Guideline:
other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vitro test system

Test system:
human skin model
Justification for test system used:
standard model
Vehicle:
water
Details on test system:
CELL CULTURE
- Supplier: SkinEthic Laboratories (Lyon, France).
- Source: adult human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
Control samples:
yes, concurrent negative control
yes, concurrent vehicle
Amount/concentration applied:
16 mg test material per tissue spread with 10 µL deionized water to matching tissue size
Duration of treatment / exposure:
42 min
Duration of post-treatment incubation (if applicable):
n.a.
Number of replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
1.947
Remarks on result:
other:
Remarks:
Time point: 42 min. Max. score: 2.054. Remarks: mean of 3 values (2,054, 1.893, 1.895). (migrated information)
Irritation / corrosion parameter:
other:
Value:
93.92
Remarks on result:
other:
Remarks:
Time point: 42 min. (migrated information)
Other effects / acceptance of results:
Optical density (as a marker of cell viability) of test item is comparable to value of the negative control. The test is to be considered as valid because:
a) optical density of negative control (mean value: 2.074+/-2.9%) > 0.8 and < 3.0 and standarad deviation <= 18%. Historical mean= 1.423
b) relative cell viability of the positive control (mean value: 1.10; standard deviation 2.22%) < 3.42% and standard deviation <= 18%
c) standard deviation of test item < 18%

Any other information on results incl. tables

 Group Time / [min]  Mean OD  Mean Relative viability / [%]
 Negative Control 42   2.074 100 
 Positive Control 42

0.023

1.10 

 Test Material

42

1.947

93.92 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was negative in this assay.