Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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.
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-02-21 to 2018-XX-XX
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- none
- Analytical monitoring:
- yes
- Remarks:
- unspecific
- Details on sampling:
- In order to verify the maintenance of the WAFs during the ecotoxicological testing, chemical analyses in daphnids test solutions were performed:
- In fresh solutions at the beginning of the test (T = 0h) and after renewal (T=24h)
- In old solutions (T = 24h and T= 48h)
The test tube were pooled randomly (2*10mL) for chemical analyses.
Schedule analysis at initial time:
- T0h Control Fresh
- T0h 100.0 mg/L Fresh
All the “Fresh” solutions were analysed taken directly from the starting solutions without daphnids.
Schedule analysis at 24h:
- T24h Control Old
- T24h 100.0 mg/L Old
- T24h Control Fresh
- T24h 100.0 mg/L Fresh
Schedule analysis at final time:
- T48h Control Old
- T48h 100.0 mg/L Old - Vehicle:
- no
- Details on test solutions:
- TEST ITEM PREPARATION
The test item was not soluble in the test medium, a special solubilisation protocol was carried out
before the experimentation, according to the OECD n°23 guidance document on aquatic toxicity te
sting of difficult substances and mixtures. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Daphnia magna Straus, clone number 5, from at least the third generation (i.e. the third brood)
obtained with a non-cyclic parthenogenesis reproduction.
The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any to
xic vapour and in medium M4.
Daphnids used in this experimentation were less than 24 hours old.
- Feeding during test: None - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- not applicable
- Hardness:
- 250 mg.L-1 (as CaCO3).
- Test temperature:
- 20.8 and 20.9°C
- pH:
- 7.31 - 8.18
- Dissolved oxygen:
- > 60% of the air-saturation value
- Salinity:
- n.a.
- Conductivity:
- n.a.
- Nominal and measured concentrations:
- nominal: 0.6, 1.3, 2.9, 6.3, 13.7 and 30.0 mg.L-1.
- Details on test conditions:
- TEST DETAILS
- Test vessel: glass test tube
- Type: closed
- Renewal rate of test solution: Renewal of test solutions at 24h
- No. of organisms per vessel: 5
- Test medium: The medium M4 ELENDT was prepared from concentrated stock solutions in ultr
apure water as described in the guideline.
16h light : 8h dark - Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 14.818 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- The 48-hour EL50 value was determined by the computer program ToxRat.
After 48 hours of exposure, immobilisation rates were 0% at 0.6, 1.3, 2.9 and 6.3 mg.L-1, 30% at 13.7 mg.L-1 and 100% at 30.0 mg.L-1. - Results with reference substance (positive control):
- no data
- Reported statistics and error estimates:
- It was not possible to perform the ANOVA
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, 48h-EL50 of the test item is 14,818 mg/L.
- Executive summary:
A study was performed to assess the acute toxicity of test item Essential oil of Commiphora myrrha to Daphnia magna. The method was designed to be compliant with OECD Guideline for Testing of Chemicals No. 202, “Daphnia sp., Acute Immobilisation Test”, referenced as Method C.2 of Commission Regulation No. 440/2008 (amended byCommission Regulation (EU) 2016/266) and with the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). The criterion measured was the EL50 (Median Effective Loading rate), a statistically derived concentration which is expected to cause immobility in 50% of test animals within a period of 48 hours.
Following a preliminary range-finding test, twenty daphnids (four replicates, five daphnids per replicate) were exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading values of 0.6, 1.3, 2.9, 6.3, 13.7 and 30.0 mg.L-1 and to a control. The immobilisation of the daphnids was determined in a closed semi-static 48-hour test by visual observation after 24 and 48 hours. Concentration of dissolved organic material in the control and the WAFs was checked by analysis of Total Organic Carbon (TOC) at start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h).
The analytical results of this test showed that organic compounds in the loading rates of interest were found to be overall stable between the start and the end of each exposure period (t=0h-t24hOldand t=24hFresh-t=48h), within the ± 20% of the initial TOC concentrations values. After 48 hours of exposure, immobilisation rates were 0% at 0.6, 1.3, 2.9 and 6.3mg.L-1, 30% at 13.7mg.L-1and 100% at 30.0mg.L-1.
The EL50at the end of the test was as follows:
Time (h)
EL50(mg test item.L-1)
95% confidence limits (mg test item.L-1)
48
14.818
n.d.
n.d.: not determined due to mathematical reasons or inappropriate data
Statistical analyses were performed by the computer program ToxRat
Under the experimental conditions and based on nominal loading rates, the 48-hour EL50 value was 14.818 mg.L-1.
Reference
Acute immobilisation of daphnids after 24 and 48 hours in the range-finding test (semi-static test).
Nominal concentration* (mg test item.L-1) |
Replicate |
Number of daphnids exposed |
Response at 24h |
Response at 48h |
|||
Number |
Total % |
Number |
Total % |
||||
Control |
1 2 |
5 5 |
0 0 |
0 |
0 0 |
0 |
|
1 |
1 2 |
5 5 |
0 0 |
0 |
0 0 |
0 |
|
10 |
1 2 |
5 5 |
0 0 |
0 |
4** 5 |
90 |
|
32 |
1 2 |
5 5 |
0 1 |
10 |
5 5 |
100 |
|
100 |
1 2 |
5 5 |
5 5 |
100 |
5 5 |
100 |
* WAF prepared at the given loading rate.
The WAFs were filtered since fine particles were observed in the mixing vessels.
** The surviving daphnia was very weak.
Description of key information
The toxic effect of test item Essential oil of Commiphora myrrha to the freshwater invertebrate Daphnia magna was investigated in a closed semi-static test usingWater Accommodated Fractions. Under the experimental conditions andbased on nominal loading rates, the 48-hour EL50value was 14.818 mg.L-1.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 14.818 mg/L
Additional information
For that endpoint, an experimental GLP study with the registered substance was available.
This study was performed to assess the acute toxicity of test item Essential oil of Commiphora myrrha to Daphnia magna. Themethod was designed to be compliant with OECD Guideline for Testing of Chemicals No. 202, “Daphnia sp., Acute Immobilisation Test”, referenced as Method C.2 of Commission Regulation No. 440/2008 (amended byCommission Regulation (EU) 2016/266) and with the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). The criterion measured was the EL50 (Median Effective Loading rate), a statistically derived concentration which is expected to cause immobility in 50% of test animals within a period of 48 hours.
The 48–hr-acute toxicity of test item to D. magna was studied under semi-static conditions. Daphnids were exposed to control and test chemical at nominal concentration of 0.6, 1.3, 2.9, 6.3, 13.7 and 30.0 mg a.i./L for 48hr. WAF was performed to obtain that range. Mortality/immobilization and sublethal effects were observed daily. The 48– hour EL50 was 14.818 mg/L.
Based on the results of this study, test item would not be classified as aquatic acute 1 in accordance with the CLP classification system.
All the validity crietria were fulfilled. This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
Results Synopsis
Test Organism Age: 24hr
Test Type: Semi Static
EC50: 14.818 mg/L
Endpoint(s) Effected: immobilisation
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.