Registration Dossier
Registration Dossier
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EC number: 620-464-3 | CAS number: 1003859-14-0
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)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU / OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- [(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amine
- EC Number:
- 620-464-3
- Cas Number:
- 1003859-14-0
- Molecular formula:
- C8H9ClF2N2
- IUPAC Name:
- [(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amine
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:
- 100% (undiluted)
50% (w/v) in AOO
25% (w/v) in AOO - No. of animals per dose:
- 5 animals/group
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 100% (undiluted): 6.6 50% (w/v) in AOO: 4.0 25% (w/v) in AOO: 1.8 Negative control (AOO): 1.0 Positive control (25% HCA in AOO): 18.5
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 100% (undiluted): 1506.5 50% (w/v) in AOO: 918.2 25% (w/v) in AOO: 405.4 Negative control (AOO): 226.8 Positive control (25% HCA in AOO): 4200.8
Any other information on results incl. tables
No mortality or systemic toxicity was observed during the study. There were no indications of any irritancy at the site of application.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of the present assay the test item was shown to have a sensitization potential (sensitizer) in the Local Lymph Node Assay.
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