Registration Dossier
Registration Dossier
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EC number: 500-035-6 | CAS number: 25214-63-5 (>1 <8.5 mol PO)
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 Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
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:
- Ethylenediamine, propoxylated
- EC Number:
- 500-035-6
- EC Name:
- Ethylenediamine, propoxylated
- Cas Number:
- 25214-63-5
- Molecular formula:
- (C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5
- IUPAC Name:
- Ethylenediamine, propoxylated
- Details on test material:
- Name: Ethylenediamine, propoxylated
Molecular weight: 360
Color: brownish
Purity: not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: Rabbit
- Strain: Himalayan
- Sex: males
- Source: Leuschner & Co., Germany
- Age: approximately 5 months
- Weight at study initiation: 2300 - 2500 g
- Number of animals: 3
- Controls: surrounding untreated skin area served as control
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: undiluted
- Area of exposure: approx. 6 cm2
- Occlusion: semiocclusive
- Vehicle: none
- Total volume applied: 500 µl
- Postexposure period: 7 days
- Removal of test substance: after 4h patches were removed and skin sites evaluated
EXAMINATIONS
- Scoring system: Draize
- Examination time points: 1, 24, 48, and 72 hours after patch removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1
- Edema: 0
SKIN REACTIONS: All three rabbits exposed for 4 hours to 0.5 ml, ethylenediamine, propoxylated showed an erythema (grade 1) at the examination time-point 60 minutes after patch removal, rabbit no. 1 until 24 hours and rabbit no. 3 until 48 hours after patch removal.
REVERSIBILITY: All test sites appeared normal at 72 hours. - Other effects:
- None
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the present test conditions slight irritation was observed with ethylenediamine, propoxylated. The findings do not warrant classification as skin irritant under GHS.
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