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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The experiment was performed between 19 December 2017 and 21 December 2017,
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 492 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- Adopted 28 July 2015
- Deviations:
- yes
- Remarks:
- Difference of viability between the 2 tissues treated with the positive control was 31.46%, instead of 20%. Considering the fact that these values are conformed to our historical data, this deviation is without impact on the conclusion of the study.
- 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:
- SURCE OF THE 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
Test animals / tissue source
- Species:
- other: reconstructed human cornea-like epithelium tissues
- Details on test animals or tissues and environmental conditions:
- The 0.60 cm² Reconstructed human Cornea-like Epithelia (EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation, batch No. 27018) were received on 19 December 2017.
The same day, the tissues in their well shipping container were equilibrated at room temperature for 15 minutes. Then the inserts (filter + epithelium) were gently removed from the agarose while
avoiding leaving agarose on the polycarbonate filter. They were placed in 6 wells culture plate which had been previously filled with 1 mL of 37°C pre-warmed assay medium (MatTek Corporation, batch No. 121817ISA) and incubated during 19 hours and 55 minutes at standard culture conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 30 minutes at 37 °C, 5% CO2, 95% humidity (standard culture conditions).
- Duration of post- treatment incubation (in vitro):
- After 30 minutes of exposure, extensive rinsing with DPBS at room temperature, a 12 minutes post-exposure immersion period at room temperature and a 2 hours and 03 minutes post-exposure incubation at standard culture conditions.
- Number of animals or in vitro replicates:
- Test item, negative and positive controls were applied on duplicate tissues (2 living RhCE tissue replicates)
- Details on study design:
- The 0.60 cm² Reconstructed human Cornea-like Epithelia (EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation, batch No. 27018) were received on 19 December 2017.
The same day, the tissues in their well shipping container were equilibrated at room temperature for 15 minutes. Then the inserts (filter + epithelium) were gently removed from the agarose while
avoiding leaving agarose on the polycarbonate filter. They were placed in 6 wells culture plate which had been previously filled with 1 mL of 37°C pre-warmed assay medium (MatTek Corporation, batch No. 121817ISA) and incubated during 19 hours and 55 minutes at standard culture conditions.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: %mean viability
- Run / experiment:
- Main test - 30 minutes
- Value:
- 97.37
- 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:
- MEAN PERCENT TISSUE VIABILITIES
- The mean corrected percent tissue viability of the RhCE replicates treated with the test item was 97.37 %, versus 18.36% in the positive control (Methyl acetate).
ACCEPTANCE OF RESULTS:
- The mean percent tissue viabilities obtained with the positive control and negative controls are within the range of historical data and therefore validate the experiment.
The difference of viability between the 2 tissues treated with the positive control was 31.46%, instead of 20% at the maximum as initially scheduled.
Considering the results obtained and the fact that these values are conformed to our historical data, this deviation is considered as without impact on the conclusion of the
study.
Any other information on results incl. tables
Table 7.3.2/1: Assessment of the eye irritation potential individual and average values of OD after 30 minutes exposure
Items |
Tissues |
OD |
Mean OD/disc# |
Mean OD / product |
Viability% |
Mean viability% |
Difference of viability% |
Conclusion |
Negative control |
1 |
0.920 |
0.950 |
0.951 |
99.95 |
100.00 |
0.11 |
- |
0.952 |
||||||||
0.978 |
||||||||
2 |
0.933 |
0.951 |
100.05 |
|||||
0.954 |
||||||||
0.967 |
||||||||
Positive control |
3 |
0.023 |
0.025 |
0.175 |
2.63 |
18.36 |
31.46 |
UN GHS category 2 or 1 |
0.026 |
||||||||
0.027 |
||||||||
4 |
0.318 |
0.324 |
34.09 |
|||||
0.321 |
||||||||
0.334 |
||||||||
Test item |
5 |
0.907 |
0.945 |
0.926 |
99.42 |
97.37 |
4.10 |
- |
0.974 |
||||||||
0.955 |
||||||||
6 |
0.897 |
0.906 |
95.32 |
|||||
0.916 |
||||||||
0.905 |
#: mean of 3 values (triplicate of the same extract)
OD: optical density
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.
No hazard statement and the signal word are required. - Executive summary:
The aim of the study was to evaluate the eye hazard potential of the test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle after topical administration on in vitro reconstructed human cornea-like epithelium tissues (EpiOcularTM tissue model).
The test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle was applied as supplied, at the dose of 50 μL, to 2 living DPBS pre-treated RhCE (EpiOcularTM tissue model) during 30 minutes at 37°C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with DPBS at room temperature, a 12 minutes post-exposure immersion period at room temperature and a 2 hours post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay. The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 492 adopted 28 July 2015.
The mean percent tissue viability of the RhCE replicates treated with the test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle was 97.37%, versus 18.36% in the positive control (Methyl acetate). In conclusion, under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item HUILE ESSENTIELLE MYRRHE SOMALIE 100% pure et naturelle does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.
No hazard statement and the signal word are required.
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