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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 284-510-0 | CAS number: 84929-26-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Commiphora myrrha, Burseraceae.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- On going study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Commiphora myrrha, ext.
- EC Number:
- 284-510-0
- EC Name:
- Commiphora myrrha, ext.
- Cas Number:
- 84929-26-0
- Molecular formula:
- Not relevant, UVCB substance
- IUPAC Name:
- Commiphora myrrha, ext.
- Test material form:
- liquid
- Details on test material:
- Storage room temperature
CAS N°18016-37-31
EC N° 284-510-0
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J (CBA/JRj)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest-Saint-Isle, France.
- Age at study initiation: 8 weeks
- Weight at study initiation: 20.2-23.8 g
- Housing: Animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood wood flakes.
- Diet: Teklad Global 16% Protein Rodent Diet (Envigo, 2016), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: at least5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- On going study
- No. of animals per dose:
- On going study
- Details on study design:
- Day 1
The weight of each animal is recorded and the thickness of the right ear of each animal of the vehicle control and treated groups is measured using a micrometer.
Open application of 25 µL of the appropriate dilution of the test item, the vehicle alone, or the positive control (as appropriate), are done to the dorsum of each ear. The test item is spread over the entire dorsal of the ear using the tip of the micropipette.
• GROUP 1 (Negative control): 25 µL of the vehicle
• GROUP 2 (Treated): 25 µL of the appropriate dilution of the test item (low concentration).
• GROUP 3 (Treated): 25 µL of the appropriate dilution of the test item (medium concentration).
• GROUP 4 (Treated): 25 µL of the appropriate dilution of the test item (high concentration).
Day 2
The application procedure carried out on day 1 is repeated.
Day 3
The thickness of the right ear is measured and then the application procedure carried out on day 1 is repeated.
Day 4
No treatment.
Day 5
0.5 mL (5 mg/mouse) of BrdU (10 mg/mL) solution is injected intra -peritoneally
Day 6
The weight of each animal is recorded.
Approximately 24 hours (24 h) after BrdU injection, the mice are sacrificed with an intraperitoneal injection of sodium pentobarbital (Dolethal®).
The thickness of the right ear of each animal of the vehicle control and treated groups is measured using a micrometer and punch biopsies of 8 mm in diameter. The apical area of both ears is prepared and weighed in order to assess the irritation potential of the test item.
For each individual animal of each group the draining auricular lymph nodes are excised. - Statistics:
- No data
Results and discussion
- Positive control results:
- On going studies
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: EC1.6
- Remarks on result:
- other: on-going
- Key result
- Parameter:
- SI
- Variability:
- To be performed
- Test group / Remarks:
- To be performed
- Remarks on result:
- other: on-going
- Key result
- Parameter:
- SI
- Variability:
- To be performed
- Test group / Remarks:
- To be performed
- Remarks on result:
- not measured/tested
- Parameter:
- SI
- Variability:
- To be performed
- Test group / Remarks:
- To be performed
- Remarks on result:
- other: on-going
Any other information on results incl. tables
Study on-going
Applicant's summary and conclusion
- Interpretation of results:
- other: Study on-going
- Conclusions:
- Study on-going
- Executive summary:
Study on-going
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.
