Registration Dossier
Registration Dossier
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EC number: 500-094-8 | CAS number: 37208-53-0 1 - 6.5 moles propoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- TS: 2, 2', 2''-Nitrilotriethanol, propoxylated, (Mm = approx. 340 g/mol)
Lot No: 20104
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of undiluted test material was applied.
- Duration of treatment / exposure:
- 1 hour and 3 minute exposure periods
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal / flank area
- % coverage: 2.5 X 2.5 cm
- Type of wrap if used: Cotton gauze patch secured with a surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM: Draize Classiification Scheme
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Max. score is 4 for erythema and 4 for edema.
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as a non-irritant according to Draize classification scheme.
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