Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November to December 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. certificate)

Test material

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

Test animals

Species:
human
Details on test animals and environmental conditions:
human skin model; 37°C ± 2°C, 5% CO₂ ± 2%, 70 - 100% humidity

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
The test item was applied topically to the each skin equivalent by using a plastic spoon. Because of the low density of the test item at least 20mg were applied.
Duration of treatment / exposure:
The test item “K-36” was tested according to OECD-Guideline 431 in the In Vitro test via human skin model over a time period of 3 minutes and 60 minutes. The 3 min incubation was performed at RT and the 60 min exposure was incubated at 37°C ± 2°C, 5% CO₂ ± 2%, 70 - 100% humidity.
Observation period:
60 min
Number of animals:
0 - in-vitro test
Details on study design:
epiCS Epidermal Skin Test

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Viability (%)
Basis:
mean
Time point:
other: 3
Score:
87.3
Irritation parameter:
other: Viability (%)
Basis:
mean
Time point:
other: 60
Score:
85
Irritant / corrosive response data:
No irritant/ corrosive response

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test item “K-36” was considered to be non-corrosive to skin according to OECD Guideline 431. The positive controls prove additionally the well functioning of the skin models.
Executive summary:

The test item “K-36” was tested according to OECD-Guideline 431 in the In Vitro test via human skin model over a time period of 3 minutes and 60 minutes. According to the definition of the OECD-Guideline 431 the test item was considered to be non-corrosive.