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EC number: 285-364-0 | CAS number: 85085-34-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Abies balsamea, Pinaceae.
- 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
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Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 May 2018 - 15 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 301 D (Ready Biodegradability: Closed Bottle Test)
- Version / remarks:
- July 17, 1992
- Deviations:
- yes
- Remarks:
- The difference of extremes of replicate values of the removal of the test substance at the plateau (Day 28) was greater than 20 % during the test. No presumed effect.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.3110 (Ready Biodegradability)
- Version / remarks:
- January 1998
- Deviations:
- yes
- Remarks:
- The difference of extremes of replicate values of the removal of the test substance at the plateau (Day 28) was greater than 20 % during the test. No presumed effect.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
- Version / remarks:
- 14 February 2017
- Deviations:
- yes
- Remarks:
- The difference of extremes of replicate values of the removal of the test substance at the plateau (Day 28) was greater than 20 % during the test. No presumed effect.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fir, Abies balsamea, ext.
- EC Number:
- 285-364-0
- EC Name:
- Fir, Abies balsamea, ext.
- Cas Number:
- 85085-34-3
- IUPAC Name:
- Fir Balsam Oil
- Test material form:
- liquid
- Details on test material:
- Name of test material as cited in study report: Fir Needle Oil Canadian (Fir, Abies Balsamea, ext)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Botanical source and Lot# 67919
- Expiration date of the lot/batch: 13 septembre 2018
- Purity test date: UVCB, considered 100% pure
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (15-25 °C, ≤ 70 RH%), protected from light, avoid contact with iron.
Study design
- Oxygen conditions:
- not specified
- Inoculum or test system:
- sewage, domestic, adapted
- Details on inoculum:
- The inoculum: Secondary effluent, microorganisms from a domestic waste water treatment plant.
Origin: The secondary effluent was supplied from the sewage plant for domestic sewage in Veszprém, Hungary.
Conditioning: The secondary effluent used for this study was allowed to settle approximately for an hour, then the decanted effluent was aerated until use (not later than an hour). - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 2.3 mg/L
- Based on:
- test mat.
- Remarks:
- Based on measured COD
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- RECONSTITUTED WATER
1) Stock solutions
In deionised water, analytical grade salts were added to prepare the following stock solutions:
a) Solution: KH2PO4 2.125 g (VWR PROLABO, Lot# 17B134115, Exp 31 January 2022)
K2HPO4 5.4375 g (VWR PROLABO, Lot# 17K164125, Exp 25 September 2022)
Na2HPO4 x 12H2O 16.795 g (VWR PROLABO, Lot# 17F274113, Exp 08 March 2022)
NH4Cl 0.125 g (SIGMA ALDRICH, Lot# BCBM9152V, Exp 29 February 2020)
Deionised water ad 250 mL
b) Solution: MgSO4 x 7 H2O 5.625 g (VWR PROLABO, Lot# 17A184115, Exp 31 December 2021)
Deionised water ad 250 mL
c) Solution: CaCl2 x 2 H2O 9.10 g (VWR PROLABO, Lot# 16L154110, Exp 31 August 2021)
Deionised water ad 250 mL
d) Solution: FeCl3 x 6 H2O 0.25 g (SIGMA ALDRICH, Lot# BCBJ9853V, Exp 30 September 2018)
Deionised water ad 1000 mL
2) Ratio of ingredients
Adequate amount of the stock solutions a) - d) were combined and filled up with deionised water to the appropriate final volume (ratio of composition referring to 1 mL of the stock solutions a) - d) filled up with deionised water to a final volume of 1000 mL according to the guideline). The test medium was aerated for 20 minutes and allowed to stand for about 20 hours at the test temperature. The dissolved oxygen concentration was 8.5 mg/L at about 22 °C.
TEST UNITS
Type and Size: BOD bottles (300 ml) with special neck and glass stoppers.
Identification: Each test flask was uniquely identified with study code, test group, days of measurement and replicate number.
TEST CONDITIONS
The test was carried out in an incubator and controlled environment room (during the formulation and oxygen measuring) at a temperature of 22 +- 2 °C according to guideline. The test flasks were placed into an incubator and kept at 20.0 - 23.4 °C, in the dark. The temperature was measured on weekdays during the experiment.
The oxygen concentration of test water was 8.5 mg/L at the start of the test.
The pH value of the test water was checked prior start of the experiment. The pH of the test water was 7.38.
The test conditions were measured with suitable instruments and documented in the raw data.
PREPARATION OF THE TEST SOLUTIONS
The respective amount of Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) was weighed in directly to reach the required test item concentration of 2.3 mg/L.
The chosen test item concentration was based on measured chemical oxygen demand (COD): 2.59 ±0.060 mg test item and on the performed 14-d preliminary test.
The components were applied in the amounts/volumes in the test flasks:
1.) Test Item (flasks 1a and 1b)
Based on the measured chemical oxygen demand (COD) of 2.59 mg O2/mg test item, 7.8 mg of Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) was thoroughly mixed into 3.40 litres of aqueous test medium (corresponding to 2.3 mg/L test item, with a COD of about 5.957 mg O2/L).
2.) Procedure Control: Sodium benzoate (flasks 2a and 2b)
Based on the theoretical oxygen demand (ThOD) of Sodium benzoate (1.67 mg O2 per mg; details on calculation are given in the guidelines), stock solution* corresponding to 12.168 mg of Sodium benzoate was mixed into 3.38 litres of aqueous test medium (corresponding to 3.6 mg/L reference item, respectively a ThOD of about 6.012 mg O2/L).
* The concentration of the stock solution was: 360 mg/L.
3.) Inoculum Control (flasks 3a and 3b)
Only filtered inoculum was added to 3.38 litres of aqueous test medium.
4.) Toxicity Control (flasks 4a and 4b)
The Test item (7.8 mg) and the reference item stock solution* (34.0 mL) were mixed into 3.40 litres of aqueous test medium corresponding to 2.3 mg/L test item (COD of 5.957 mg O2/L) and 3.6 mg/L reference item (ThOD of 6.012 mg O2/L).
* The concentration of the reference item stock solution was: 360 mg/L.
Microbial inoculum (0.5 mL per litre) was added to each preparation bottle.
COURSE OF THE TEST
1. Preparation of Test Flasks
Sufficient number of BOD flasks was cleaned with 5 - 10 mL of a wash liquid (2.5 g iodine and 12.5 g potassium iodide per litre of 1 % w/v sulphuric acid) by shaking well to coat the bottle walls. After allowing to stand for 15 minutes, the wash liquid was poured off, and the bottles were thoroughly rinsed with tap water and deionised water. Then, the previously described test solutions were filled into the bottles bubble-free until the bottles were completely filled. Then they were tightly closed with glass stoppers.
2. The Test Bottles
The number of test bottles was the follow:
10 bottles containing the test item and inoculum
10 bottles containing the reference item and inoculum (procedure control)
10 bottles containing only inoculum (inoculum control)
10 bottles containing the test item, reference item and inoculum (toxicity control)
MEASUREMENTS
1. Measurement of Oxygen
The incubation period of the closed bottle test was 28 days.
The oxygen concentrations were measured with an oxygen meter with a stirring O2 electrode. Oxygen measurements were performed in duplicate on days 0, 7, 14, 21 and 28.
2. Measurement of Total Oxidised N, Nitrite and Nitrate
The concentration of dissolved oxygen resulted a mean of 7.80 mg O2/L after 14 days of incubation in the test item flasks (1a and 1b), which resulted a mean of 3.4 % biodegradation within 14 days of the test item during the performed preliminary experiment, therefore samples for nitrate and nitrite analysis were not taken and measurement of the total oxidised Nitrogen (nitrate and nitrite) concentrations was not performed.
3. Measurement of Temperature
Temperature was measured continuously and registered on weekdays.
Reference substance
- Reference substance:
- other: Sodium benzoate, C7H5NaO2, Batch # A0371807, Exp: 30 April 2019, ACROS ORGANICS
Results and discussion
% Degradationopen allclose all
- Parameter:
- % degradation (O2 consumption)
- Remarks:
- Test item initial concentration is 2.3 mg/L
- Value:
- 8.3
- Sampling time:
- 0 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 7.65
- Sampling time:
- 7 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 7.2
- Sampling time:
- 14 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 7.1
- Sampling time:
- 21 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 7
- Sampling time:
- 28 d
- Details on results:
- DEVIATION FROM THE STUDY PLAN AND TEST GUIDELINE
Concerning: Conditions for the validity of the test
According to the Study Plan: The difference of extremes of replicate values of the removal of the test substance at the plateau, (at the end of the test or at the end of the 10 or 14-d window) will be less than 20 %.
Deviation: The difference of extremes of replicate values of the removal of the test substance at the plateau (Day 28) was greater than 20 % during the test.
Reason for this change: Deviation between replicates is relatively large because low degradation values cause large percentage differences.
Presumed Effect on the Study: None.Taking into account the very low biodegradation rate calculated, and that the test item was not considered to have significant inhibitory effects. Therefore this deviation is negligible and it has no impact on the results of the study, consequentlythe study is considered to be valid.
BOD5 / COD results
- Results with reference substance:
- The reference item Sodium benzoate was sufficiently degraded to a mean of 66.7 % after 14 days, and to a mean of 74.2 % after 28 days of incubation, based on ThOD, thus confirming the suitability of the used inoculum.
Any other information on results incl. tables
Table: Percentage Biodegradation at Different Time Intervals during the Exposure Period of 28 Days
Treatment |
Concentration |
Flask |
Percent of biodegradation after n days of exposure |
|||
|
[mg/L] |
No. |
7 |
14 |
21 |
28 |
Test item |
|
1a |
-1.7 |
6.7 |
5.9 |
4.2 |
2.3 |
1b |
0.0 |
6.7 |
5.9 |
7.6 |
|
|
mean |
-0.8 |
6.7 |
5.9 |
5.9 |
|
Reference item |
|
2a |
60.0 |
66.7 |
74.2 |
74.2 |
3.6 |
2b |
60.0 |
66.7 |
72.5 |
74.2 |
|
|
mean |
60.0 |
66.7 |
73.3 |
74.2 |
|
Toxicity control |
Test item: 2.3 |
4a |
29.5 |
34.2 |
36.2 |
37.8 |
4b |
29.5 |
34.2 |
37.0 |
39.4 |
||
mean |
29.5 |
34.2 |
36.6 |
38.6 |
Biodegradation % = [BOD of T or R / (COD of T or ThOD of R)]*100
where:
T = test item
R = reference item
COD of test item = 2.59 ±0.060 mg O2/mg test item
ThOD of reference item = 1.67 mg O2/mg reference item
The biodegradation in the toxicity control was calculated according to the following formula: [BOD of T and R / (COD of T + ThOD of R)*0.5]*100
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The test item Fir Needle Oil Canadian, is considered not readily biodegradable.
- Executive summary:
The test item Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) was investigated for its ready biodegradability in a Closed Bottle Test over a period of 28 days. The biodegradation was followed by the oxygen uptake of the microorganisms during exposure. As a reference item Sodium benzoate was tested simultaneously under the same conditions as the test item, and functioned as a procedure control.
The test system was a microbial inoculum of good quality, collected from a sewage plant for domestic sewage. The sludge was allowed to settle and then aerated until use.
Under the test conditions the percentage biodegradation of Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) reached a mean of 5.9 % after 28 days based on the COD of the test item. According to the test guidelines the pass level for ready biodegradability is removal of 60 % ThOD/COD. Therefore the test item is considered not readily biodegradable.
The reference item Sodium benzoate was sufficiently degraded to a mean of 66.7 % after 14 days, and to a mean of 74.2 % after 28 days of incubation, based on ThOD, thus confirming the suitability of the used inoculum.
In the toxicity control containing both, the test item and the reference item Sodium benzoate, a mean of 34.2 % biodegradation was noted within 14 days and 38.6 % biodegradation after 28 days of incubation.
According to the test guidelines the test item can be assumed to be not inhibitory at the applied concentration level of 2.3 mg/L on the secondary effluent microorganisms because degradation was >25 % within 14 days.
The test item was not considered to have significant inhibitory effects on the secondary effluent microorganisms.
Based on the results of this study, the test item is considered not readily biodegradable.
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