Registration Dossier
Registration Dossier
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EC number: 210-275-0 | CAS number: 611-70-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January to June 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Isobutyrophenone
- EC Number:
- 210-275-0
- EC Name:
- Isobutyrophenone
- Cas Number:
- 611-70-1
- Molecular formula:
- C10H12O
- IUPAC Name:
- 2-methyl-1-phenylpropan-1-one
- Details on test material:
- Isobutyrophenone
CAS: 611-70-1
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100% (w/v)
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A statistical analysis was performed for the values obtained for the ear weights to assess whether the difference is statistically significant between test item groups and the negative control (vehicle) group and also to assess if there is a dose response relationship.
For all statistical calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-Variance was used as statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test or the Student Newman Keuls test.
Results and discussion
- Positive control results:
- The S.I. of the positive control group was 7.24.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Test item concentration S.I. Vehicle 1.00 25 % Isobutyrophenone 1.39 50 % Isobutyrophenone 1.89 100 % Isobutyrophenone 2.37 25 % Positive Control 7.24
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test item concentration Mean DPM per Group (5 animals) / SD Vehicle 988.7 +/- 180 25 % Isobutyrophenone 1370.1 +/- 501 50 % Isobutyrophenone 1869.9 +/- 484 100 % Isobutyrophenone 2344.1 +/- 624 25 % Positive Control 7155.5 +/- 3559
Applicant's summary and conclusion
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