Registration Dossier
Registration Dossier
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EC number: 500-039-8 | CAS number: 25322-69-4 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Propane-1,2-diol, propoxylated
- EC Number:
- 500-039-8
- EC Name:
- Propane-1,2-diol, propoxylated
- Cas Number:
- 25322-69-4
- Molecular formula:
- (C3 H6 O)n H2 O n= >1 - <4.5
- IUPAC Name:
- propane-1,2-diol, propoxylated
- Details on test material:
- Name: Propane-1,2-diol propoxylated
Molecular weight: Mn = 260 g/mole
Physical state: pale yellow liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: Rabbit
- Strain: New Zealand White
- Sex: male/female
- Source: Hazleton Research Products, Denver
- Age: 8-12 weeks
- Weight at study initiation: 2.486-2.802 kg
- Number of animals: 6
- Controls: Untreated skin
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted (0.5 ml)
- Duration of treatment / exposure:
- 3 minutes, 60 minutes, 4 hours and 24 hours
- Number of animals:
- 6
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: undiluted
- Area of exposure: 6 cm2
- Occlusion: Semi-occluded
- Total volume applied: 0.5 ml to intact (all time period) and abraded (24 hours only) skin
- Exposure time: 3 minutes, 1, 4 and 24 hours
- Postexposure period: 72 hours post patch removal
- Removal of test substance: water and gauze
EXAMINATIONS
- Scoring system: Draize
- Examination time points: 3 minutes, 1, 4, 24, 48 and 72 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hour
- Score:
- 0.13
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: according to Draize, max. score for both erythema and edema is 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hour exposure
- Score:
- 0.04
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: according to Draize, max. score for both erythema and edema is 4
- Other effects:
- Immediately after patch removal there were no effects after 3 minute exposure, slight erythema (grade 1) in 2/6 rabbits after 1 hour, 3/6 after 4 hours and 1/6 after 24 hour exposure.
REVERSIBILITY: Complete
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This propoxylated propane-1,2-diol (molecular weight 230) was considered not irritating according to EU GHS.
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