Registration Dossier
Registration Dossier
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EC number: 937-130-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 14th to October 18th 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate on April 7th 2011
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Epoxy Resin T1600
- EC Number:
- 937-130-0
- IUPAC Name:
- Epoxy Resin T1600
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:
- 50%
- No. of animals per dose:
- Preliminary test : 2 females per dose
Main test : 4 females per dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Group 3 (vehicle) : / Group 4 (test item 5%) : 2.22 Group 5 (test item 10%) : 2.71 Group 6 (test item 25%) : 2.43 Group 7 (test item 50%) : 2.61 Group 8 (test item 100%) : 3.92 Group 9 (HCA 25%) : 7.61
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Group 3 (vehicle) : 1042 Group 4 (test item 5%) : 2313 Group 5 (test item 10%) : 2826 Group 6 (test item 25%) : 2533 Group 7 (test item 50%) : 2715 Group 8 (test item 100%) : 4080 Group 9 (HCA 25%) : 7931
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of the study, the test item, Epoxy Resin T1600, induced delayed contact hypersensitivity in the murine Local Lymph Node Assay.
According to the EC3 value obtained, the test item should be considered as a weak sensitizer.
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