Registration Dossier
Registration Dossier
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EC number: 464-390-8 | 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)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- LLNA:
OECD, Section 4, Health Effects, No.429 (2002),
EC, Council Directive 67/548/EEC, Annex V, B.42 (2004);
EPA, OPPTS 870.2600 (2003) "Skin Sensitisation". - GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Details on study design:
- Species: Mouse, CBA strain, inbred, SPF-Quality.
Recognized by the international guidelines as the recommended test system (e.g. OECD, EC, EPA).
Source: Charles River France, L'Arbresle Cedex, France
Number of animals: 20 females (nulliparous and non-pregnant), five females per group.
In the main study, three groups of five experimental animals were treated with test substance concentrations of 5%, 25% or 50% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Dimethyl sulphoxide).
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index was subsequently calculated for each group. - Positive control substance(s):
- other: Dimethyl Sulfoxide
Results and discussion
- Positive control results:
- The DPM values calculated was 430.
The SI values calculated was 1.0.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 5, 25 and 50% were 9.4, 8.9 and 12.9 respectively. These results show that the test substance elicits an SI >= 3. The EC3 value was established to be between 0 and 5%.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The DPM values calculated for the substance concentrations 5, 25 and 50% were 4038, 3835 and 5550 respectively.
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.
