Registration Dossier
Registration Dossier
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EC number: 500-078-0 | CAS number: 31923-84-9 1 - 4.5 moles propoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Apr - 24 Apr 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Ethane- 1,2-diol, propoxylated
- EC Number:
- 500-078-0
- EC Name:
- Ethane- 1,2-diol, propoxylated
- Cas Number:
- 31923-84-9
- Molecular formula:
- HO(C3H6O)nC2H4(C3H6)nOH sum of n: >1 - <4.5 mol PO
- IUPAC Name:
- Ethane-1,2-diol, propoxylated
- Details on test material:
- - Physical state: liquid
- Content: 100%
- molecular weight: approx. 235
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral untreated skin area of test animals served as control
- Amount / concentration applied:
- Amount: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h, 7 and 14 days after application
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Table 1: Iritant Effects on the Skin - (Exposure 3 min / 1 h)
Animal 1 (first animal)
Observation (immediately after patch removal) 3 min 1 h
Erythema (redness) and eschar formation 0 0
Oedema formation 0 0
Table 2: Irritant Effects on the Skin (Exposure: 4 h)
Animal 1, Body Weight 3.5 kg
Observation (after patch removal) 1 h 24 h 48 h 72 h 7 days 14 days
Erythema (redness) and eschar formation 0 0 0 0 -- --
Oedema fomation 0 0 0 0 -- --
Animal 2, Body Weight 3.3 kg
Observation (after patch removal) 1 h 24 h 48 h 72 h 7 days 14 days
Erythema (redness) and eschar formation 0 0 0 0 -- --
Oedema formation 0 0 0 0 -- --
Animal 3, Body Weight 3.2 kg
Observation (after patch removal) 1 h 24 h 48 h 72 h 7 days 14 days
Erythema (redness) and eschar formation 0 0 0 0 -- --
Oedema formation 0 0 0 0 -- --
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Ethane-1,2 -diol, propoxylated is not an irritant to the rabbit skin.
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