Registration Dossier
Registration Dossier
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EC number: 226-420-6 | CAS number: 5397-31-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals were painted with 10% test substance. After 5 days reapplication was done with 1% test substance on untreated skin.
- GLP compliance:
- no
- Type of study:
- skin painting test
- Justification for non-LLNA method:
- another acceptable animal study was already available
Test material
- Reference substance name:
- 3-(2-ethylhexyloxy)propylamine
- EC Number:
- 226-420-6
- EC Name:
- 3-(2-ethylhexyloxy)propylamine
- Cas Number:
- 5397-31-9
- Molecular formula:
- C11H25NO
- IUPAC Name:
- 3-[(2-ethylhexyl)oxy]propan-1-amine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: aceton
- Concentration / amount:
- induction: 10%
challenge: 1%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: aceton
- Concentration / amount:
- induction: 10%
challenge: 1%
- No. of animals per dose:
- 10 in test group
3 in control group - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 10 days
- Site: left side
- Frequency of applications: first seven daily, three days no application than 3 further daily applications
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 19
- Exposure period: 1 day
- Site: right side
- Concentrations: 1%
- Evaluation (hr after challenge): 24 hours
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- one animal showed erythema score 1 and one animal showed erythema score 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: one animal showed erythema score 1 and one animal showed erythema score 2.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Any other information on results incl. tables
After induction all animals showed necrosis at induction side.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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