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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Haematoxylin
EC Number:
208-237-3
EC Name:
Haematoxylin
Cas Number:
517-28-2
Molecular formula:
C16H14O6
IUPAC Name:
haematoxylin

In vitro test system

Test system:
artificial membrane barrier model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: epiCS® supplied by CellSystems
Source strain:
other:
Vehicle:
unchanged (no vehicle)
Amount/concentration applied:
25 mg
Duration of treatment / exposure:
3 minutes and 1 hour

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minute exposure
Value:
ca. 100
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1-hour exposure
Value:
ca. 92.64
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Pink coloration was noted in all Human skin model surfaces treated during 1 hour.
3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 104.55% (considered as 100%) and 92.64%, versus 5.24% and 0.42%, respectively, with the positive control item (potassium hydroxide 8N).
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item HEMATOXYLIN HPL (CAS 517-28-2) does not have to be classified in Category 1 “Corrosive”.
Executive summary:

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item HEMATOXYLIN HPL (CAS 517-28-2) does not have to be classified in Category 1 “Corrosive”.

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