Registration Dossier
Registration Dossier
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EC number: 444-140-4 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (maximisation).
- GLP compliance:
- yes
- Type of study:
- other: maximisation
Test material
- Reference substance name:
- -
- EC Number:
- 444-140-4
- EC Name:
- -
- Cas Number:
- 18934-00-4
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 3-ethyl-3-{[(3-ethyloxetan-3-yl)methoxy]methyl}oxetane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Guinea pig (Dunkin-Hartley)
- Details on test animals and environmental conditions:
- Concentration of test material and vehicle used at induction:
Intradermal Induction:
10% in Alembicol D
Topical Induction:
100%
Concentration of test material and vehicle used for each challenge:
1st challenge
a, 75% in Alembicol D
b, 37.5% in Alembicol D
No. of animals per dose
Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 37.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 37.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 75 % Signs of irritation during induction: Intradermal Induction Slight irritation was seen in test animals at sites receiving, 10% in Alembicol D and slight irritation was observed in control animals receiving Alembicol D. Topical Application Slight erythema was observed in test animals following topical application. Slight erythema was seen in one control guinea-pig. Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of sensitisation at each challenge concentration: 0/10
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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