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EC number: 289-621-8 | CAS number: 89957-99-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Boswellia papyrifera, 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:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- From 2019-01-04 to 2019-01-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- See QMRF and QPRF in "attached background material" section.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- QSAR model
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- yes
- Remarks:
- QSAR model
- Principles of method if other than guideline:
- The acute toxicity to the daphnids was determined using a calculation method for the Mechanism of Action (MechoA) in question (non-polar narcosis). The QSAR model is based on validated data for a training set of 58 chemicals derived from 48-hour test
on daphnids, for which the concentrations of the test item had been determined by chemical analyses over the test period. - GLP compliance:
- no
- Specific details on test material used for the study:
- None.
- Analytical monitoring:
- no
- Remarks:
- Not applicable. See "any other information on material and methods incl. tables"
- Details on sampling:
- No data.
- Vehicle:
- no
- Details on test solutions:
- Not applicable.
- Test organisms (species):
- Daphnia sp.
- Details on test organisms:
- Results from the following species were used in the regression: Daphnia magna, Daphnia pulex
- Test type:
- other: QSAR model. See "details on test conditions"
- Water media type:
- not specified
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Results from a test duration of 48 hours only were used
- Post exposure observation period:
- Not applicable.
- Hardness:
- Not applicable.
- Test temperature:
- Not applicable.
- pH:
- Not applicable.
- Dissolved oxygen:
- Not applicable.
- Salinity:
- Not applicable.
- Conductivity:
- Not applicable.
- Nominal and measured concentrations:
- Not applicable.
- Details on test conditions:
- Calculation method.
- Reference substance (positive control):
- not required
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 12 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: Based on typical composition
- Details on results:
- Not applicable.
- Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- Not applicable.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The following toxicity value has been predicted for the registered substance: 48h-EL50 = 12 mg/L.
- Executive summary:
A calculation method prediction was performed to assess the acute toxicity to Daphnia sp. of the test item, OLIBANUM OIL (Bowsellia papyrifera), using the WAF method. This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the Guideline for Testing of Chemicals No. 202, "Daphnia sp., Acute Immobilisation Test", referenced as Method C.2 of Commission Regulation No. 440/2008 adapted for testing of a mixture using the WAF method. The criterion predicted was the median effective loading rate of the mixture EL50 (Median Effect Loading), a statistically derived loading rate which is expected to cause immobility in 50% of test animals within a period of 48 hours.
The results below is the acute toxicity value anticipated during a 48-hour EL50study on daphnids based on the WAF method.The 48-hour EL50is calculated as follows:
Composition
Time (h)
EL50(mg test item.L-1)
typical
48
12
Reference
Determination of the Analytically Measurable Aqueous Phase (AMAP).
Using the model, the specific concentration of each constituent in the WAF can be accurately determined at any loading rate taking into account the original composition of the mixture and the new corrected limit of solubility of each constituent. The sum of these concentrations, the AMAP, is equivalent to the concentration of all constituents that would be measured in a WAF test. For a given loading rate, the loaded concentration of each constituent is compared to its respective solubility limit. If one is higher than the solubility limit then it is considered that the concentration of the constituent will be equal to its solubility limit. If lower, the true loading concentration is considered. Provided this adapted water solubility limits for each consitutents. analytically measurable concentrations in aqueous solutions expected from known WAF loading rates of characterised mixtures can be calculated. The AMAP expected at the EL50 is given below:
Analytically Measured Aqueous Phase (AMAP) calculated at the predicted EL50.
constituents |
concentration in the WAF (mg.L-1) |
||
Constituent 1 |
6.64 |
||
Constituent 2 |
0.722 |
||
Constituent 3 |
0.108 |
||
Constituent 4 |
0.0945 |
||
Constituent 5 |
3.32E-05 |
||
Constituent 6 |
6.41E-06 |
||
Constituent 7 |
0.126 |
||
Constituent 8 |
5.31E-03 |
||
Constituent 9 |
0.183 |
||
Constituent 10 |
6.84E-04 |
Description of key information
The following toxicity value has been estimated for the registered substance:48h-EL50 = 12 mg test item/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 12 mg/L
Additional information
For that endpoint, one reliable study was available: an in-house calculation method that replaces an OECD 202 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). A typical composition of the substance has been investigated.The algorithm used for the purpose of this study is based on a QSAR model which has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004).
A calculation method prediction was performed to assess the acute toxicity to Daphnia sp. of the test item, OLIBANUM OIL (Bowsellia papyrifera), using the WAF method. This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the Guideline for Testing of Chemicals No. 202, "Daphnia sp., Acute Immobilisation Test", referenced as Method C.2 of Commission Regulation No. 440/2008 adapted for testing of a mixture using the WAF method. The criterion predicted was the median effective loading rate of the mixture EL50 (Median Effect Loading), a statistically derived loading rate which is expected to cause immobility in 50% of test animals within a period of 48 hours.
The results below is the acute toxicity value anticipated during a 48-hour EL50study on daphnids based on the WAF method.The 48-hour EL50is calculated as follows:
Composition |
Time (h) |
EL50(mg test item.L-1) |
typical |
48 |
12 |
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.
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