Registration Dossier
Registration Dossier
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EC number: 929-459-3 | CAS number: -
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1 % solution in Acetone/Olive Oil (4:1) SI-Value 1.05
3 % solution in Acetone/Olive Oil (4:1) SI-Value 1.09
10 % solution in Acetone/Olive Oil (4:1) SI-Value 1.40 - No. of animals per dose:
- Test group: 18 animals
Control group: 6 animals
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 1 % solution in Acetone/Olive Oil (4:1) SI-Value 1.05 3 % solution in Acetone/Olive Oil (4:1) SI-Value 1.09 10 % solution in Acetone/Olive Oil (4:1) SI-Value 1.40
Any other information on results incl. tables
RAC-BEPP dest. has a moderate sensitizing potential in mice after dermal application of a 10 % concentration. In addition, a pronounced non-specific (irritating) activation can not be exlcluded after application of a 10% concentration, which could have an impact on cell proliferation of the draining lymph nodes. The concentration of 3% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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