Registration Dossier
Registration Dossier
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EC number: 442-520-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 14th to May 31st, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 17th, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- July 31st ,1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Yellow 6314-PPT
- IUPAC Name:
- Yellow 6314-PPT
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- 0.5 g (per animal) of the test item was moistened with approximately 0.1 ml of purified water before application.
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 ,24, 48 and 72 hours, as well as 7 and 10 days after removal of the dressing.
- Number of animals:
- 3 animals (1 male and 2 females).
- Details on study design:
- The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC (July 31st, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Erythema was reversible and was no longer evident 72 hours after removal of the dressing. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.
- Other effects:
- VIABILITY/MORTALITY/CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
COLORATION:
A light yellow staining was present at the test site of all animals form 1 to 72 hours after removal of the dressing and was observed again in one animal 7 days after treatment.
BODY WEIGHTS:
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008).
- Conclusions:
- Not irritant to skin.
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