Registration Dossier
Registration Dossier
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EC number: 610-465-7 | CAS number: 49621-56-9
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Concerning: Expiry date of Freund’s complete adjuvant (FCA) According to the Study Plan: 30 April 2009 Deviation: 30 April 2008 Reason for the Deviation: miswritten Presumed Effect on the Study: None
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Justification for non-LLNA method:
- The LLNA method does not need to be conducted since there is a in vivo skin sensitization study available according to previous legislation.
Test material
- Reference substance name:
- 3-(3,4-Dimethoxyphenyl)propanenitrile
- EC Number:
- 610-465-7
- Cas Number:
- 49621-56-9
- Molecular formula:
- C11H13NO2
- IUPAC Name:
- 3-(3,4-Dimethoxyphenyl)propanenitrile
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50 microl
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 0.72
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- ca. 0.71
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 0.65
- Test group / Remarks:
- 50%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item was classified as a non-sensitiser.
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