Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start date:16 February 2009; end date: 20 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Custom Red #2
- Substance type:
- Physical state: Violet powder
- Lot/batch No.: C50APR0805D
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- other: EpiDerm Skin Model
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg, moistened with 25 μl of Milli-Q water - Duration of treatment / exposure:
- 3 minutes and 1 hour exposure on human skin model
- Details on study design:
- TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: after 3 minutes or 1 hour
SCORING SYSTEM: % viability of the cells
Results and discussion
In vivo
Results
- Irritation parameter:
- other: percentage viability
- Basis:
- other: 2 tissues per exposure time
- Time point:
- other: 3 minutes and 1 hour
- Score:
- ca. 83 - ca. 90
Any other information on results incl. tables
Mean tissue viability in thein vitro skin corrosion test with Custom Red #2
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Custom Red #2 |
83 |
90 |
Positive control |
7 |
7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive
- Remarks:
- Criteria used for interpretation of results: other: OECD guideline 431
- Conclusions:
- Custom Red #2 is not corrosive in the in vitro skin corrosion study.
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