Registration Dossier
Registration Dossier
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EC number: 251-459-0 | CAS number: 33329-35-0
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:
- other: Non GLP, non guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No data.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine
- EC Number:
- 251-459-0
- EC Name:
- N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine
- Cas Number:
- 33329-35-0
- Molecular formula:
- C15H36N4
- IUPAC Name:
- (3-{bis[3-(dimethylamino)propyl]amino}propyl)dimethylamine
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: abraded and unabraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 4-72 hours
- Observation period:
- 30 days
- Number of animals:
- 18
6 per group
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 4 of 5
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: exatrapolated from 48 h erythema score
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: extrapolated from 48 h edema score
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Corrosion score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- other: Corrosion score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- other: Corrosion score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- other: Corrosion score
- Basis:
- other:
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- erythema score
- Basis:
- other: 4 of 5
- Time point:
- other: 4 Hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- erythema score
- Basis:
- other: 4 of 5
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- erythema score
- Basis:
- animal: 4 of 5
- Time point:
- other: 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritation parameter:
- erythema score
- Basis:
- animal: 4 of 5
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
- Irritant / corrosive response data:
- The substance is severely corrosive to the skin of rabbits. Corrosive effects observed on intact and abraded skin, not reversible after 30 days.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is severely corrosive to the skin of rabbits. Corrosive effects observed on intact and abraded skin, not reversible after 30 days.
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