Registration Dossier
Registration Dossier
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EC number: 500-030-9 | CAS number: 9051-49-4 1 - 5.5 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
- Reference substance name:
- Pentaerythritol, propoxylated
- EC Number:
- 500-030-9
- EC Name:
- Pentaerythritol, propoxylated
- Cas Number:
- 9051-49-4
- Molecular formula:
- (C3 H6 O)n (C3 H6 O)m (C3 H6 O)x (C3 H6 O)y C5 H12 O4 1 < (n + m + x + y) < 8.5
- IUPAC Name:
- 12,12-bis[(2-hydroxypropoxy)methyl]-5,8,16,19-tetramethyl-4,7,10,14,17,20-hexaoxatricosane-2,22-diol; 12-[(2-hydroxypropoxy)methyl]-12-{[2-(2-hydroxypropoxy)propoxy]methyl}-5,8,16-trimethyl-4,7,10,14,17-pentaoxaicosane-2,19-diol; 9,9-bis({[2-(2-hydroxypropoxy)propoxy]methyl})-5,13-dimethyl-4,7,11,14-tetraoxaheptadecane-2,16-diol
- Details on test material:
- Pentaerythritol, propoxylated, (Molecular weight Mn = 420 g/mole)
Lot No. 0024
Storage: Room temperature in the dark.
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:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hr average
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hr average
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hr average
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hr average
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hr average
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hr average
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites 24 h after patch removal. One treated skin site appeared normal throughout the study and the remaining two treated skin sites appeared normal at the 48 hour observation. According to EU classification criteria, the test substance is not a skin irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a PII of 0.3 and classified as a mild irritant to rabbit skin according to Draize classification scheme. Findings do not warrant classification in the EU.
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