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Diss Factsheets
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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.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
In an GLP study conducted in compliance with OECD guideline 4442B with the registered substance, an EC1.6 value will be provided (study on going).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- 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 - 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
- Positive control results:
- On going studies
- 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
- Interpretation of results:
- other: Study on-going
- Conclusions:
- Study on-going
- Executive summary:
Study on-going
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Study on-going
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.