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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU7OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test system

Vehicle:
physiological saline
Amount / concentration applied:
25 mg per insert plus 50 µL 0.9% NaCl to moisten and ensure good contact with the skin
Duration of treatment / exposure:
60 min

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: viability
Basis:
mean
Time point:
other: 60 min
Score:
61.96
Irritation parameter:
other: viability
Basis:
mean
Time point:
other: 3 min
Score:
102.29
Irritant / corrosive response data:
Tested on the skin/epidermal equivalents in triplicate.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The results show that no corrosive property of the test item was determined by the assay used.