Registration Dossier
Registration Dossier
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EC number: 939-292-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- April 28,2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP compliant, summary report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- corrosive test in vitro
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Direct Brown 44
- IUPAC Name:
- Direct Brown 44
Constituent 1
Test animals
- Species:
- other: Control tissue
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 1 hour
- Details on study design:
- SCORING SYSTEM: % of killed tissue
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: % of killed tissue
- Value:
- ca. 0
- Remarks on result:
- other:
- Remarks:
- Basis: other: in vitro test. Time point: 1 hour. Max. score: 100.0. (migrated information)
Any other information on results incl. tables
| Exposure 3 minutes | ||||||
| optical density | ||||||
| test article | tissue 1 | tissue 2 | KC | mean Optical density | mean Optical density KC corrected | Viability(% of NC) |
| NC | 2.105 | 2.057 | 0.245 | 2.083 | - | 100 |
| 03/0250-2 | 2.354 | 2.244 | 0.265 | 2.299 | - | 110 |
| PC_C | 0.351 | 0.32 | - | 0.335 | - | 16 |
| Exposure 1 hour | ||||||
| optical density | ||||||
| test article | tissue 1 | tissue 2 | KC | mean Optical density | mean Optical density KC corrected | Viability(% of NC) |
| NC | 1.925 | 2.13 | 0.184 | 2.028 | - | 100 |
| 03/0250-2 | 2.49 | 1.913 | 0.223 | 2.202 | - | 108 |
| PC_C | 0.196 | 0.196 | - | 0.198 | - | 10 |
NC: negative control
PC_C: positive control
KC: killed tissue control
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive under Regulation 1272/2008
- Conclusions:
- Evaluation: non corrosive
- Executive summary:
An in vitro study using the EpiDerm TM human skin model showed the non-corrosivity of the substance. In order to further assess the acute skin Irritation potential of the test substance a dermal irritation/corrosion test in White New Zealand rabbits was performed according to the method described in OECD guideline 404.
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