Registration Dossier
Registration Dossier
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EC number: 936-795-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- See certificate in study report
Test material
- Reference substance name:
- 864970-33-2
- Cas Number:
- 864970-33-2
- IUPAC Name:
- 864970-33-2
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 grams
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24 hours and 48 hours
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0.2
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin one hour after patch removal and at one treated skin at the 24-hour observation. One treated skin appeared normal throughout the study, one other treated skin appeared normal at the 24-hour observation and the remaining treated skin appeared normal at the 48_hour observation. No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The organic part of PACTT, 2 Na is not classified as irritant for skin. As the mineral part of PACTT, 2 Na, Sodium Bromide, is not either classified as irritant for skin, it can be concluded that the multi-constituent substance has not to be classified as irritant for skin.
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