Registration Dossier
Registration Dossier
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EC number: 208-584-0 | CAS number: 534-03-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR, Part 798, Subpart E Section 798.4470, Toxic Substances Control Act, 1994
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-aminopropane-1,3-diol
- EC Number:
- 208-584-0
- EC Name:
- 2-aminopropane-1,3-diol
- Cas Number:
- 534-03-2
- Molecular formula:
- C3H9NO2
- IUPAC Name:
- 2-aminopropane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): APD-1, 3
- Lot/batch No.: 227-124
- Analytical purity: No data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: test substance was slightly moistened with USP 0.9% sodium chloride for injection
- Controls:
- other: Adjacent areas of untreated skin served as control sites
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, slightly moistened with USP 0.9% sodium chloride for injection - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sited were wiped clean.
- Time after start of exposure: 4 hours.
SCORING SYSTEM:
Performed according to the Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- None of the test animals exhibited signs of erythema or edema during the 72 hour observation period. All the scores were 0 at all reading time points.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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