Registration Dossier
Registration Dossier
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EC number: 466-280-5 | CAS number: 67643-70-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 466-280-5
- EC Name:
- -
- Cas Number:
- 67643-70-3
- Molecular formula:
- C13H23NO2
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-yl N,N-dimethylcarbamate
- Details on test material:
- Batch No. 9000575061
Purity: 97.4%
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% and 50% in acetone/olive oil (4:1) and 100% (undiluted)
- No. of animals per dose:
- 3 groups each of four female mice
1 control group of four female
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: Group 2 ; test item concentration 25% ; SI=1.6 Group 3; test item concentration 25% ; SI=2.0 Group 4; test item concentration 100% (undiluted) ; SI=1.5
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.I.)
GR-86-0999 was therefore found to be a non-sensitizer when tested at up to the concentration 100% (undiluted)
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