Registration Dossier
Registration Dossier
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EC number: 200-338-0 | CAS number: 57-55-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study published in a peer-reviewed literature, using the standard method; brief reporting, but acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Strategies for identifying false positive responses in predictive skin sensitization tests
- Author:
- Basketter DA, Gerberick GF, Kimber I
- Year:
- 1 998
- Bibliographic source:
- Food and Chemical Toxicology, 36, 327-333
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propane-1,2-diol
- Details on test material:
- No data are provided.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data are provided.
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- 50% and 100%
- No. of animals per dose:
- 4/dose
- Details on study design:
- Groups of 4 mice were treated with 25 µl of test material on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days following the initiation of exposure all mice were injected via the tail vein with 250 µl phosphate buffered saline containing 20 µC tritiated thymidine. Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single cell suspension of lymph node cells is prepared by mechanical disaggregation, washed twice in excess of PBS, then precipitated with 5% trichloroacetic acid at 4 °C for 18 hr. Pellets were resuspended in trichloroacetic acid and incorporation of tritiated thymidine was measured by ß-scintillation counting.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 100%
- Parameter:
- SI
- Remarks on result:
- other: For 50% solution: 1.2 For 100% test substance: 1.6
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.
