Registration Dossier
Registration Dossier
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EC number: 228-995-9 | CAS number: 6388-26-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 28 to April 6, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- GLP compliance:
- no
Test material
- Reference substance name:
- Direct Green 026
- IUPAC Name:
- Direct Green 026
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h: 3 rabbits
1 h or 3 min: 1 rabbit - Observation period:
- 72 h
- Number of animals:
- 4 h: 3 rabbits
1 h or 3 min: 1 rabbit - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- 'Dermal toxicity' in Appraisal of the safety of chemicals in foods, drugs and cosmetics, Assoc. of food and drug offcials of the US, Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- Dark green coloured staining is observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non irritant to the rabbit skin.
- Executive summary:
Method
Skin irritation in rabbits according to OECD guideline 404. A single 4 -hour, semi occluded application (0.5 g) of test substance was administered to the intact skin of 3 rabbits; 3 -minute and 1 -hour semioccluded applications (0.5 g) of test substance were administered to the intact skin of one rabbit. Observations for erythema and oedema were done 24, 48 and 72 hours after start of exposure.
Results
No signs of erythema and oedema were noted. Dark-green coloured staining was noted.
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