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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The experiment was performed between 09 November 2017 and 16 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 439 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Version 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 27 April 2017
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:
- Batch No.: 0021835
Date received: 17 October 2017
Storage: room temperature, darkness
Form: liquid
Colour: amber-yellow to green-yellow
Production date: June 2017
Best before date: October 2019
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Batch No.: 0021835
Date received: 17 October 2017
Storage: room temperature, darkness
Form: liquid
Colour: amber-yellow to green-yellow
Production date: June 2017
Best before date: October 2019
In vitro test system
- Test system:
- human skin model
- Source species:
- other:
- Cell type:
- other: reconstructed epidermis
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- The 0.50 cm² reconstructed epidermises (Episkin SA, RHE/S/17 Batch No. 17-RHE-116) were received on 13 November 2017. The same day, the insert (filter + epidermis) was gently removed
from the agarose while avoiding leaving agarose on the polycarbonate filter. The inserts were placed in 6 wells culture plate which had been previously filled with 1 mL of growth medium (Episkin SA, batch No. 17 SGM 033) during 2 hours and 05 minutes. Then just before treatment, the inserts were placed in 24 wells culture plate which had been previously filled with 300 μL of maintenance medium (Episkin SA, batch No. 17 SMM 022). The two killed Reconstructed Human epidermis control tissue models, supplied by Episkin (Batch No. 17-RHE-021) were defrost on 21 February 2017, re-freeze on 21 February 2017 and defrost to be used on 28 February 2017.
TREATMENT
- The test item was applied, as supplied, at the dose of 16 µL, to the epidermal surface of 3 living human skin models and 2 killed Reconstructed Human epidermis (for non-specific MTT reduction control) during 42 minutes at room temperature. To ensure a good contact with the epidermises, during all the treatment period, the test item was recovered with a nylon mesh provided by Episkin SA.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Test item was applied for 42 minutes at room temperature
- Temperature of post-treatment incubation: 41 hours and 50 minutes post-treatment incubation period in fresh medium at 37 °C, 5% CO2 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 µL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 42 minutes at room temperature.
- Duration of post-treatment incubation (if applicable):
- 41 hours and 50 minutes post-incubation period at 37 °C, 5% CO2
- Number of replicates:
- 3 living human skin models and 2 killed Reconstructed Human epidermis (for non-specific MTT reduction control)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test (42 minutes)
- Value:
- 92.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- VIABILITY
- The mean corrected percent viability of the treated tissues was 92.5%), versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate).
Any other information on results incl. tables
Table 7.3.1/1: Assessment of the skin irritation - individual and average values of OD after 42 minutes exposure
Items |
Skin |
OD |
Mean OD/disc# |
Mean OD/product |
Viability% |
Mean viability% |
SD |
Conclusion |
Negative control |
1 |
0.958 |
1.073 |
1.001 |
107.2 |
100.0 |
8.7 |
- |
1.129 |
||||||||
1.133 |
||||||||
2 |
1.009 |
1.1026 |
102.5 |
|||||
1.018 |
||||||||
1.052 |
||||||||
3 |
0.885 |
0.904 |
90.3 |
|||||
0.912 |
||||||||
0.917 |
||||||||
Positive control |
4 |
0.010 |
0.010 |
0.012 |
1.0 |
1.2 |
0.2 |
Irritant |
0.011 |
||||||||
0.011 |
||||||||
5 |
0.011 |
0.011 |
1.1 |
|||||
0.011 |
||||||||
0.011 |
||||||||
6 |
0.014 |
0.014 |
1.4 |
|||||
0.015 |
||||||||
0.014 |
||||||||
Test item |
7 |
1.012 |
1.062 |
0.926 |
106.1 |
92.5 |
16.7 |
Non irritant |
1.128 |
||||||||
1.046 |
||||||||
8 |
0.771 |
0.739 |
73.8 |
|||||
0.733 |
||||||||
0.713 |
||||||||
9 |
1.065 |
0.976 |
97.5 |
|||||
0.765 |
||||||||
1.098 |
≠: mean of 3 values (triplicate of the same extract)
OD: optical density
Acceptance criteria: SD ≤ 18%
Negative control: OD value of the 3 replicates in the range ≥ 0.8 and ≤ 3.0.
The optical density was measured after a 1:2 dilution of the formazan extracts in isopropanol; the acceptability criteria should be in the range ≥ 0.4 and ≤1.5 for the negative control.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these experimental conditions and in accordance with the Regulation (CE) No.1272/2008 and in absence of information on a skin corrosion, the test item has not to be classified.
- Executive summary:
The aim was to evaluate the possible irritating effects of the test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model).
The test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle was applied as supplied at the dose of 16 μL, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes. The application was followed by a rinse with 25 mL of DPBS and a 41 hours and 50 minutes post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 439 adopted 28 July 2015 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30
May 2008 (E.U. Journal L142).
The mean percent viability of the treated tissues was 92.5% versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
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