Registration Dossier
Registration Dossier
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EC number: 466-380-9 | CAS number: 52350-17-1
Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted 22 Jul 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008
- Deviations:
- no
Test material
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.07
- Test group / Remarks:
- 10% (w/w) in propylene glycol
- Remarks on result:
- other: Result: Negative
- Key result
- Parameter:
- SI
- Value:
- ca. 0.96
- Test group / Remarks:
- 25% (w/w) in propylene glycol
- Remarks on result:
- other: Result: Negative
- Key result
- Parameter:
- SI
- Value:
- ca. 1.58
- Test group / Remarks:
- 50% (w/w) in propylene glycol
- Remarks on result:
- other: Result: Negative
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS: none
BODY WEIGHTS: no significant changes
Any other information on results incl. tables
Disintegrations per minute, Disintegrations per minute/node, Stimulation Index, and Result
Concentration (% w/w) in propylene glycol |
dpm |
dpm/nodea |
Stimulation Indexb |
Result |
Vehicle |
6946.46 |
868.31 |
NA |
NA |
10 |
7433.47 |
929.18 |
1.07 |
Negative |
25 |
6665.40 |
833.18 |
0.96 |
Negative |
50 |
10986.49 |
1373.31 |
1.58 |
Negative |
dpm = disintegrations per minute
a= dpm/node obtained by dividing the dpm value by 8 (the total number of lymph nodes)
b= Stimulation Index of 3.0 or greater indicates a positive result
NA = not applicable
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
