Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-140-9 | CAS number: 752984-24-0
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 according EU/OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-amine
- EC Number:
- 700-140-9
- Cas Number:
- 752984-24-0
- Molecular formula:
- C11H15N
- IUPAC Name:
- (1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-amine
Constituent 1
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:
- 0 (vehicle control), 3, 10 and 30%.
- No. of animals per dose:
- 6 mice per group
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: The NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant but not sensitising
- Executive summary:
This study does point to a non-specific (irritant) immunostimulating potential of the test item.
This applies to NMRI mice, for weight and cell counts of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application of the test substance. The "positive level" of ear swelling which is 2x10-2mm increase, i.e. more than 10% increase in index, has been exceeded in the high dose group. This increase is statistically significant compared to vehicle treated animals. An increase of the ear weights could also be determined in the animals of the high dose group compared to control animals. Therefore, it must be concluded that the test item has an irritant potential at the highest concentration tested, i.e. 30%.
Taken together, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30% test substance by the method used. Therefore, the concentration of 30% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
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.
