Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vitro Skin Irritation and Corrosion with EpiDerm
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22Apr2015
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
See individual study reports for purity information and CofA where applicable
Specific details on test material used for the study:
Test substance No.: 14/0424-1
Batch identification: 0008205061
CAS No.: 97404-02-9
Physical state / color: Solid / red

In vitro test system

Test system:
human skin model
Source species:
human
Cell source:
other: Human reconstituted epidermis model EpiDerm™
Control samples:
yes, concurrent MTT non-specific colour control
other: freeze-killed control tissues (KC CC)
Amount/concentration applied:
Form of application: undiluted

Negative control (NC): De-ionized water (corrosion test) I PBS, sterile (irritation test)

Positive control (PC): 8 N KOH (corrosion test) / 5% SOS in de-ionized water, sterile (irritation test)

MTT-reduction control (KC): De-ionized water or test substance (corrosion test) PBS, sterile or test substance (irritation test)

Color control (CC): Test substance

Killed color control (KC CC): Test substance
Duration of treatment / exposure:
The test consists of a single topical exposure of the undiluted test substance to the surface of a human reconstituted epidermis model EpiDerm™ for 3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours postincubation (irritation test) followed by a cell viability test.
Duration of post-treatment incubation (if applicable):
The test consists of a single topical exposure of the undiluted test substance to the surface of a human reconstituted epidermis model EpiDerm™ for 3 minutes and 1 hour (corrosion test) or 1 hour with 42 hours postincubation (irritation test) followed by a cell viability test.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Irritation test, 1 hour exposure
Value:
74
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Corrosion test, 3 min exposure
Value:
105.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Corrosion test, 1 hour exposure
Value:
94.6
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that the test item does not show a skin irritation potential in the EpiDerm TM in vitro skin irritation and corrosion test strategy under the test conditions chosen .
Executive summary:

Based on the observed results and applying the evaluation criteria it was concluded, that the test item does not show a skin irritation potential in the EpiDermTM in vitro skin irritation and corrosion test strategy under the test conditions chosen.