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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 289-632-8 | CAS number: 89958-10-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Bulnesia sarmienti, Zygophyllaceae.
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20/01-2015 - 27/01/2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- in accordance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bulnesia sarmienti, ext.
- EC Number:
- 289-632-8
- EC Name:
- Bulnesia sarmienti, ext.
- Cas Number:
- 89958-10-1
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, and structural formula canoot be given.
- IUPAC Name:
- Essential oil of Guaiacwood obtained from the wood of Bulnesia sarmientoi by steam distillation
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Guaiacwood essential oil
- Physical state: solid
- Storage condition of test material: At room temperature
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: WAFs prepared at loading rates of 0.32, 1.0, 3.2, 10, 32 and 100 mg/l
- Sampling method: 50 ml samples were taken after 0 and 72 hours.
- Sample storage conditions before analysis: Samples were stored in a refrigerator until analysis. Additionally, reserve samples of 50 ml were taken for possible analysis. If not used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The batch of Guaiacwood essential oil tested was a yellowish/brown solid and a mixture of components with poor water solubility.
Water Accommodated Fractions (WAFs) were prepared at individual loading rates ranging from 0.32 to 100 mg/l. Exact amounts of test substance were added to test medium containing no HEPES buffer and magnetically stirred for 2 days in closed vessels with minimal headspace. Thereafter, all solutions were left to stabilise overnight. Subsequently, the WAFs were collected by siphoning the water phase and distributed over the test vessels. The final test solutions were clear and colourless.
After preparation, volumes of 110 ml were added to each vessel containing 2.2 ml of algal suspension (providing a cell density of 104 cells/ml) and HEPES buffer (0.66 ml) was spiked to each vessel.
Solutions for analysis of TOC concentrations:
• At the start of the test: samples were taken from freshly prepared solutions (before preparation of the exposure vessels).
• At the end of the exposure period: volumes of 110 ml solutions of the same WAFs added at t=0 to the vessels containing no algae. These vessels were not spiked with HEPES buffer.
This was done to prevent that the carbon originating from the buffer will obscure the results.
- Controls: Yes, blanks
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source (laboratory, culture collection): In-house laboratory culture.
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C and a light intensity of 60 to 120 μE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm. Cells were cultured in M1 medium. 3 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 10^4 cells/ml. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg/l CaCO3
- Test temperature:
- 21 - 23ºC
- pH:
- 7.1 - 7.8
- Nominal and measured concentrations:
- Nominal: Control and WAFs prepared at loading rates of 0.32, 1.0, 3.2, 10, 32 and 100 mg/l
Measured (t=0h):Measured (t=72h): - Details on test conditions:
- TEST SYSTEM
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 120 ml, all-glass, containing 110 ml of test solution, closed airtight.
- Aeration: none
- Initial cells density: 1 x 10^4 cells/ml
- Control end cells density: 138.3 x 10^4 cells/ml
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 3
- TOC analysis: 2 replicates of each group without algae for sampling purposes (these replicates contained no HEPES buffer but were incubated at the same conditions as the other replicates)
GROWTH MEDIUM
- Standard medium used: yes, adjusted M2 medium (according to OECD 201) with the following composition:
NH4Cl 15 mg/l
MgCl2.6H2O 12 mg/l
CaCl2.2H2O 18 mg/l
MgSO4.7H2O 15 mg/l
KH2PO4 1.6 mg/l
FeCl3.6H2O 64 μg/l
Na2EDTA.2H2O 100 μg/l
H3BO3 185 μg/l
MnCl2.4H2O 415 μg/l
ZnCl2 3 μg/l
CoCl2.6H2O 1.5 μg/l
CuCl2.2H2O 0.01 μg/l
Na2MoO4.2H2O 7 μg/l
NaHCO3 300 mg/l
Hardness (Ca+Mg) 0.24 mmol/l (24 mg CaCO3/l)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Milli-RO water
- Culture medium different from test medium: No
- Intervals of water quality measurement: pH (at the start and end of the test), temperature (continuously)
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: 6 mmol/l HEPES-buffer added
- Photoperiod: Continuously
- Light intensity and quality: TLD-lamps with a light intensity within the range of 78 to 79 μE.m-2.s-1.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: At the beginning of the test, cells were counted using a microscope and a counting chamber. Thereafter cell densities were determined by spectrophotometric measurement of samples at 720 nm using a spectrophotometer with cuvettes (path length =10 mm). Algal medium was used as blank.
- Other: At the end of the final test microscopic observations were performed at the WAF of 3.2 mg/l (i.e. concentration in which the number of cells was approximately 50% lower than in the control) to observe for any abnormal appearance of the algae.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study
- Test concentrations: 1,0, 10 and 100 mg/l
- Results used to determine the conditions for the definitive study: yes- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 7.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL: 4 - 10 mg/l
- Duration:
- 72 h
- Dose descriptor:
- EL20
- Effect conc.:
- 11 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL: 6.8 - 13 mg/l
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 21 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% Cl: 17 - 26 mg/l
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 0.12 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% CL: 0.02 - 0.31 mg/l. Indicative value obtained by extrapolation of the dose-response curve.
- Duration:
- 72 h
- Dose descriptor:
- EL20
- Effect conc.:
- 0.37 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% CL: 0.10 - 0.74 mg/l. Indicative value obtained by extrapolation of the dose-response curve.
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% CL: 1.9 - 5.3 mg/l
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): At the end of the final test microscopic observations were performed at the WAF of 3.2 mg/l (i.e. concentration in which the number of cells was approximately 50% lower than in the control) to observe for any abnormal appearance of the algae.
- Any stimulation of growth found in any treatment: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- 72h-ErC50: 1.5 mg/l
- 72h-EbC50: 0.41 mg/l - Reported statistics and error estimates:
- For determination of the NOELR and the EL50 the approaches recommended in the OECD guideline 201 were used. An effect was considered to be significant if statistical analysis of the data obtained for the test concentrations compared with those obtained in the negative control revealed significant inhibition of growth rate or inhibition of yield (growth rate: Welch-t test for Inhomogeneous Variances with Bonferroni-Holm Adjustment, yield: Williams Multiple Sequential t-test Procedure; both α=0.05, one-sided, smaller).
Additionally, the EL10 and EL20 were determined to meet the recommendations as put down in "A Review of Statistical Data Analysis and Experimental Design in OECD Aquatic Toxicology Test Guidelines" by S. Pack, August 1993.
Calculation of ELx values was based on probit analysis using linear max. likelihood regression with the percentages of growth rate inhibition and the percentages of yield inhibition versus the logarithms of the corresponding loading rates of the test substance. It should be noted that the highest loading rate was not included with the analysis as it was beyond the dose-response curve.
The calculations were performed with ToxRat Professional v. 2.10.05 (ToxRat Solutions® GmbH, Germany).
Any other information on results incl. tables
Individual cell densities (x104cells/ml)
Time |
Replicate |
Guaiacwood essential oil, WAF prepared at (mg/l) |
||||||
Control |
0.32 |
1.0 |
3.2 |
10 |
32 |
100 |
||
0 h |
1 2 3 4 5 6 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
|
2 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
|
3 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
|
4 |
1.0 |
|
|
|
|
|
|
|
5 |
1.0 |
|
|
|
|
|
|
|
6 |
1.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n: |
|
6 |
3 |
3 |
3 |
3 |
3 |
3 |
Mean: |
|
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
1.0 |
Std.Dev.: |
|
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
CV: |
|
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
|
|
|
|
|
|
|
|
24 h |
1 2 3 4 5 6 |
8.439 |
10.296 |
11.885 |
10.126 |
11.927 |
7.893 |
2.844 |
|
2 |
4.382 |
9.736 |
9.602 |
8.226 |
14.984 |
8.219 |
4.304 |
|
3 |
7.651 |
12.438 |
7.864 |
6.127 |
9.701 |
6.659 |
4.127 |
|
4 |
9.864 |
|
|
|
|
|
|
|
5 |
8.623 |
|
|
|
|
|
|
|
6 |
10.935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n: |
|
6 |
3 |
3 |
3 |
3 |
3 |
3 |
Mean: |
|
8.3 |
10.8 |
9.8 |
8.2 |
12.2 |
7.6 |
3.8 |
Std.Dev.: |
|
2.2 |
1.4 |
2.0 |
2.0 |
2.7 |
0.8 |
0.8 |
CV: |
|
27.0 |
13.2 |
20.6 |
24.5 |
21.7 |
10.8 |
21.2 |
|
|
|
|
|
|
|
|
|
48 h |
1 2 3 4 5 6 |
41.519 |
37.335 |
37.271 |
36.208 |
27.741 |
4.049 |
4.687 |
|
2 |
38.222 |
39.257 |
37.555 |
33.265 |
30.237 |
3.737 |
4.453 |
|
3 |
39.647 |
46.100 |
36.073 |
29.209 |
27.294 |
3.524 |
4.808 |
|
4 |
47.908 |
|
|
|
|
|
|
|
5 |
44.731 |
|
|
|
|
|
|
|
6 |
50.397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n: |
|
6 |
3 |
3 |
3 |
3 |
3 |
3 |
Mean: |
|
43.7 |
40.9 |
37.0 |
32.9 |
28.4 |
3.8 |
4.6 |
Std.Dev.: |
|
4.8 |
4.6 |
0.8 |
3.5 |
1.6 |
0.3 |
0.2 |
CV: |
|
11.0 |
11.3 |
2.1 |
10.7 |
5.6 |
7.0 |
3.9 |
|
|
|
|
|
|
|
|
|
72 h |
1 2 3 4 5 6 |
117.863 |
99.887 |
95.200 |
83.201 |
68.820 |
5.992 |
7.708 |
|
2 |
124.720 |
99.490 |
95.270 |
75.131 |
57.765 |
4.957 |
6.006 |
|
3 |
134.010 |
108.957 |
95.001 |
57.857 |
65.487 |
2.787 |
6.871 |
|
4 |
140.137 |
|
|
|
|
|
|
|
5 |
147.717 |
|
|
|
|
|
|
|
6 |
165.190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n: |
|
6 |
3 |
3 |
3 |
3 |
3 |
3 |
Mean: |
|
138.3 |
102.8 |
95.2 |
72.1 |
64.0 |
4.6 |
6.9 |
Std.Dev.: |
|
16.9 |
5.4 |
0.1 |
12.9 |
5.7 |
1.6 |
0.9 |
CV: |
|
12.3 |
5.2 |
0.1 |
18.0 |
8.9 |
35.7 |
12.4 |
According to OECD 201, the factor of the biomass parameter, measured in the control between 0 and 72 h, must be at least 16. In the current test it was found to be 138. The test fulfils this validity criterion.
Percentage inhibition of growth rate (total test period) during the final test
Guaiacwood essential oil WAF prepared at (mg/l) |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
1.641 |
0.0403 |
6 |
0.0 |
0.32 |
1.544 |
0.0171 |
3 |
5.9# |
1.0 |
1.519 |
0.0005 |
3 |
7.5# |
3.2 |
1.422 |
0.0625 |
3 |
13.3* |
10 |
1.386 |
0.0301 |
3 |
15.6* |
32 |
0.491 |
0.1329 |
3 |
70.1* |
100 |
0.640 |
0.0416 |
3 |
61.0* |
* - effect was statistically significant
#- effect biologically insignificant (<10%)
Percentage inhibition of growth rate at different time intervals during the final test
Guaiacwood essential oil WAF prepared at (mg/l) |
n |
0 – 24 h |
24 – 48 h |
48 – 72h |
|||
Mean |
%Inhibition |
Mean |
%Inhibition |
Mean |
%Inhibition |
||
Control |
6 |
2.080 |
0.0 |
1.693 |
0.0 |
1.150 |
0.0 |
0.32 |
3 |
2.376 |
-14.2 |
1.331 |
21.4 |
0.925 |
19.6 |
1.0 |
3 |
2.267 |
-9.0 |
1.343 |
20.7 |
0.946 |
17.8 |
3.2 |
3 |
2.078 |
0.1 |
1.411 |
16.7 |
0.777 |
32.4 |
10 |
3 |
2.486 |
-19.5 |
0.860 |
49.2 |
0.810 |
29.5 |
32 |
3 |
2.023 |
2.8 |
-0.697 |
141.2 |
0.147 |
87.2 |
100 |
3 |
1.307 |
37.1 |
0.229 |
86.5 |
0.385 |
66.6 |
Percentage inhibition of yield during the final test
Guaiacwood essential oil WAF prepared at (mg/l) |
Mean |
Std. Dev. |
n |
%Decrease |
Control |
137.273 |
16.9447 |
6 |
0.0 |
0.32 |
101.778 |
5.3549 |
3 |
25.9* |
1.0 |
94.157 |
0.1396 |
3 |
31.4* |
3.2 |
71.063 |
12.9475 |
3 |
48.2* |
10 |
63.024 |
5.6708 |
3 |
54.1* |
32 |
3.579 |
1.6357 |
3 |
97.4* |
100 |
5.862 |
0.8510 |
3 |
95.7* |
* - effect was statistically significant
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Increase factor > 16 in controls, coefficient of variation of the mean specific growth rate and mean of the replicate coefficients of variation for section-by-section growth rate do not exceed validity criteria
- Conclusions:
- The acute toxicity (72h-ErL50) of Guaiacwood essential oil towards Pseudokirchneriella subcapitata is 21 mg/l.
- Executive summary:
The toxicity of Guaiacwood essential oil towards Pseudokirchneriella subcapitata was investigated according to OECD guideline 201 under GLP. Algal cells were exposed to nominal WAFs of 1.0, 3.2, 10, 32 and 100 mg/l and were observed for 72 hours. Based on nominal loading rates, the 72h-ErL10 and 72h-ErL50 were found to be 7.3 and 21 mg/l respectively.
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.