Registration Dossier
Registration Dossier
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EC number: 208-237-3 | CAS number: 517-28-2
Skin irritation / corrosion
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:
- 2 018
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
- Reference substance name:
- Haematoxylin
- EC Number:
- 208-237-3
- EC Name:
- Haematoxylin
- Cas Number:
- 517-28-2
- Molecular formula:
- C16H14O6
- IUPAC Name:
- haematoxylin
Constituent 1
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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