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EC number: 284-524-7 | CAS number: 84929-41-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Piper nigrum, Piperaceae.
- 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
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2017-03-23 to 2017-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the OECD 301F guideline. All the validity criteria were successful.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No.: 1003131757, provided by the sponsor
- Expiration date of the lot/batch: May 07, 2018
- Certificate of Analysis Date: March 03, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 20 ± 5°C, in the dark.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The amounts of test item and reference item were directly weighed into the test flasks. Silicone oil AR20 was used as an emulsifying agent. - Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: microorganisms from a domestic waste water treatment plant was supplied by the sewage treatment plant Rossdorf, Germany
The aerobic activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was resuspended in test water and centrifuged again. This procedure was done three times. An aliquot of the
final sludge suspension was weighed, dried and the ratio of wet sludge to its dry weight was determined.
Based on this ratio, calculated aliquots of washed sludge suspension, corresponding to 3.5 g dry material per litre were mixed with test water and aerated overnight. This suspension was used for the experiment. - Duration of test (contact time):
- 60 d
- Initial conc.:
- 102.7 mg/L
- Based on:
- test mat.
- Remarks:
- corresponding to an oxygen demand of about 326.3 mg/L (ThODNH4)
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Aliquots of washed sludge suspension were mixed with reconstitued test water.
- Reconstitued pure water: Analytical grade salts were added to pure water to prepare the following stock solutions:
a) 8.5 g KH2PO4, 21.75 g K2HPO4, 33.4 g Na2HPO4 x 2 H2O, 0.5 g NH4Cl filled up with pure water to 1000 mL volume; The pH-value was 7.4.
b) 11.25 g MgSO4 x 7 H2O filled up with pure water to 500 mL volume
c) 18.2 g CaCl2 x 2 H2O filled up with pure water to 500 mL volume
d) 0.125 g FeCl3 x 6 H2O filled up with pure water to 500 mL volume
In order to avoid precipitation of iron hydroxide in the stock solution d), one drop of concentrated HCl per litre was added before storage. 50 mL of stock solution a) and 5 mL of the stock solutions b) to d) were combined and filled up to a final volume of 5000 mL with pure water.
- Solubilising agent: Silicone oil AR20 was used as an emulsifying agent. (1%)
- Test temperature: 22°C ± 1°C
- pH: 7.4 to 7.9
- pH adjusted: no
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: The closed test flasks were incubated in a climatised chamber under continuous stirring.
- Number of culture flasks/concentration: 2
The test flasks were closed gas-tight by a measuring head. Potassium hydroxide solution (45%) was used for trapping the produced carbon dioxide. The amount of O2 consumed by the activated sludge was calculated from the decrease of pressure in the reaction vessel.
- Measuring equipment: BSB/BOD-Sensor- System, Aqualytic Dortmund, Germany
SAMPLING
O2 consumption measured daily.
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 (activated sludge + silicone oil + test water)
- Abiotic sterile control: 1
- Toxicity control: 1
- Other: Procedure control : (Ref. Item + activated sludge + silicone oil + test water) - Reference substance:
- acetic acid, sodium salt
- Preliminary study:
- No data.
- Test performance:
- No data.
- Parameter:
- % degradation (O2 consumption)
- Remarks:
- ThODNH4
- Value:
- 34
- Sampling time:
- 14 d
- Parameter:
- % degradation (O2 consumption)
- Remarks:
- ThODNH4
- Value:
- 53
- Sampling time:
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Remarks:
- ThODNH4
- Value:
- 72
- Sampling time:
- 60 d
- Details on results:
- The mean biodegradation of 10% of Pepper black oil was reached at day 4. At the end of the 10-day window at day 14, the mean degradation of Pepper black oil was 34% and therefore the 10 day window criterion was not passed. The mean biodegradation at day 28 was 53%; therefore the test was prolonged till day 60. 60% biodegradation or more was reached at day 38, when the mean degradation was 60%.
Afterwards an increase of degradation could be determined till day 59, when the plateau of biodegradation was reached; the mean degradation was 72% at day 59. Afterwards the degradation of Pepper black oil remained constant and was 72% at test end after 60 days.
Results for all flasks are illustrated in the attached figure 1. - Results with reference substance:
- The reference item sodium benzoate was sufficiently degraded to 77% after 14 days, to 77% after 28 days and to 78 % after 60 days of incubation.
The percentage biodegradation of the reference item confirms the suitability of the used aerobic activated sludge inoculum. - Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Pepper black oil is considered to be not readily biodegradable after 28 days, but reached a degradation of 72% after 60 days.
All the validity criteria were fulfilled. - Executive summary:
The test item Pepper black oil was investigated for its ready biodegradability in a manometric respirometry test over a period of 60 days according to the OECD 301F guideline.
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 mean biodegradation of 10% of Pepper black oil was reached at day 4. At the end of the 10-day window at day 14, the mean degradation of Pepper black oil was 34% and therefore the 10 day window criterion was not passed. The mean biodegradation at day 28 was 53%; therefore the test was prolonged till day 60. 60% biodegradation or more was reached at day 38, when the mean degradation was 60%.
Afterwards an increase of degradation could be determined till day 59, when the plateau of biodegradation was reached; the mean degradation was 72% at day 59. The degradation of Pepper black oil remained constant and was 72% at test end after 60 days.
Pepper black oil is considered to be not readily biodegradable after 28 days, but reached a degradation of 72% after 60 days.
Validity criteria:
The oxygen demand of the inoculum control was not greater than 60 mg O2/L within 28 days. The pH-value of the test item flasks at the end of the test was within the range of pH 6.0 to 8.5.
The reference item sodium benzoate was degraded to more than 60% after 4 days of incubation.
The difference of duplicate values for the degradation of the test item at the end of the 10-day window, at the plateau and at the end of the test was less than 20%.
The biodegradation in the toxicity control was 37% at day 14; the test item was not inhibitory.
All the validity criteria were fulfilled.
Reference
pH-Values at the End of the Test
Flask No. | Treatment | pH-value |
1 | Pepper black oil | 7.4 |
2 | Pepper black oil | 7.4 |
3 | Inoculum control | 7.6 |
4 | Inoculum control | 7.6 |
5 | Reference item (procedure control) | 7.9 |
Cumulative Biochemical Oxygen Demand (mg O2/L) in Test Flasks during the Test Period of 60 Days
Time | Flask No. | ||||||
(days) | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
1 | 0 | 0 | 0 | 0 | 45 | 0 | 60 |
2 | 5 | 10 | 5 | 5 | 85 | 0 | 90 |
3 | 30 | 40 | 5 | 5 | 105 | 0 | 110 |
4 | 50 | 55 | 5 | 10 | 115 | 0 | 120 |
5 | 60 | 60 | 10 | 10 | 125 | 0 | 130 |
6 | 70 | 70 | 10 | 10 | 135 | 0 | 135 |
7 | 80 | 80 | 10 | 15 | 140 | 0 | 145 |
8 | 90 | 90 | 10 | 15 | 145 | 0 | 155 |
9 | 100 | 100 | 15 | 20 | 150 | 0 | 165 |
10 | 105 | 105 | 15 | 20 | 150 | 0 | 175 |
11 | 110 | 110 | 15 | 20 | 150 | 0 | 180 |
12 | 115 | 120 | 15 | 20 | 155 | 0 | 190 |
13 | 120 | 130 | 15 | 20 | 155 | 0 | 200 |
14 | 130 | 135 | 20 | 25 | 155 | 0 | 205 |
15 | 135 | 145 | 20 | 25 | 155 | 0 | 210 |
16 | 140 | 155 | 20 | 25 | 160 | 0 | 215 |
17 | 145 | 160 | 20 | 25 | 160 | 0 | 220 |
18 | 150 | 165 | 20 | 25 | 160 | 0 | 225 |
19 | 155 | 170 | 25 | 25 | 160 | 0 | 230 |
20 | 160 | 175 | 25 | 25 | 160 | 0 | 235 |
21 | 165 | 180 | 25 | 25 | 160 | 0 | 240 |
22 | 170 | 185 | 25 | 25 | 160 | 0 | 245 |
23 | 175 | 185 | 25 | 25 | 160 | 0 | 245 |
24 | 180 | 190 | 25 | 30 | 160 | 0 | 250 |
25 | 185 | 190 | 25 | 30 | 160 | 0 | 255 |
26 | 190 | 195 | 25 | 30 | 160 | 0 | 255 |
27 | 195 | 195 | 25 | 30 | 160 | 0 | 255 |
28 | 200 | 200 | 25 | 30 | 160 | 0 | 255 |
29 | 200 | 200 | 25 | 30 | 160 | 0 | 255 |
30 | 200 | 205 | 25 | 30 | 160 | 0 | 255 |
31 | 205 | 210 | 25 | 30 | 160 | 0 | 255 |
32 | 210 | 210 | 25 | 30 | 160 | 0 | 255 |
33 | 210 | 215 | 25 | 30 | 160 | 0 | 255 |
34 | 210 | 215 | 25 | 30 | 160 | 0 | 255 |
35 | 210 | 220 | 25 | 30 | 160 | 0 | 255 |
36 | 210 | 220 | 25 | 30 | 160 | 0 | 255 |
37 | 215 | 225 | 25 | 30 | 160 | 0 | 255 |
38 | 215 | 230 | 25 | 30 | 160 | 0 | 255 |
39 | 220 | 230 | 25 | 30 | 160 | 0 | 255 |
40 | 220 | 235 | 25 | 35 | 160 | 0 | 255 |
41 | 220 | 235 | 25 | 35 | 160 | 0 | 255 |
42 | 225 | 235 | 25 | 35 | 160 | 0 | 255 |
43 | 225 | 240 | 25 | 35 | 160 | 0 | 255 |
44 | 230 | 240 | 25 | 35 | 160 | 0 | 255 |
45 | 230 | 245 | 25 | 35 | 160 | 0 | 255 |
46 | 235 | 245 | 25 | 35 | 160 | 0 | 255 |
47 | 235 | 245 | 25 | 35 | 160 | 0 | 255 |
48 | 240 | 250 | 25 | 35 | 160 | 0 | 255 |
49 | 240 | 250 | 25 | 35 | 160 | 0 | 255 |
50 | 245 | 250 | 25 | 35 | 160 | 0 | 255 |
51 | 245 | 255 | 25 | 35 | 165 | 0 | 255 |
52 | 245 | 255 | 25 | 35 | 165 | 0 | 255 |
53 | 250 | 255 | 25 | 35 | 165 | 0 | 255 |
54 | 250 | 260 | 25 | 35 | 165 | 0 | 260 |
55 | 250 | 260 | 25 | 35 | 165 | 0 | 260 |
56 | 250 | 265 | 25 | 35 | 165 | 0 | 260 |
57 | 255 | 265 | 25 | 35 | 165 | 0 | 260 |
58 | 255 | 265 | 25 | 35 | 165 | 0 | 260 |
59 | 255 | 270 | 25 | 35 | 165 | 0 | 260 |
60 | 255 | 270 | 25 | 35 | 165 | 0 | 260 |
Flasks 1 and 2: Pepper black oil | |||||||
Flasks 3 and 4: inoculum control | |||||||
Flask 5: reference(procedure control) | |||||||
Flask 6: abiotic control | |||||||
Flask 7: toxicity control |
Percentage Biodegradation of Test Item, of Sodium Benzoate and of the Toxicity Control based on ThODNH4:
Time | Percentage Biodegradation1 | |||
(Days) | Pepper black oil1 | Sodium Benzoate2 | Toxicity | |
control1, 2 | ||||
Flask 1 [%] | Flask 2 [%] | Flask 5 [%] | Flask 7 [%] | |
1 | 0 | 0 | 26 | 12 |
2 | 0 | 2 | 46 | 17 |
3 | 8 | 11 | 58 | 21 |
4 | 13 | 15 | 62 | 23 |
5 | 15 | 15 | 67 | 24 |
6 | 18 | 19 | 73 | 25 |
7 | 21 | 21 | 74 | 27 |
8 | 24 | 24 | 77 | 29 |
9 | 25 | 25 | 77 | 30 |
10 | 27 | 27 | 77 | 32 |
11 | 28 | 29 | 77 | 33 |
12 | 30 | 32 | 80 | 35 |
13 | 31 | 35 | 80 | 37 |
14 | 33 | 35 | 77 | 37 |
15 | 34 | 38 | 77 | 38 |
16 | 36 | 41 | 80 | 39 |
17 | 37 | 42 | 80 | 40 |
18 | 39 | 44 | 80 | 41 |
19 | 40 | 45 | 78 | 41 |
20 | 41 | 46 | 78 | 42 |
21 | 43 | 48 | 78 | 43 |
22 | 44 | 49 | 78 | 44 |
23 | 46 | 49 | 78 | 44 |
24 | 46 | 50 | 77 | 45 |
25 | 48 | 50 | 77 | 46 |
26 | 50 | 52 | 77 | 46 |
27 | 51 | 52 | 77 | 46 |
28 | 53 | 53 | 77 | 46 |
29 | 53 | 53 | 77 | 46 |
30 | 53 | 55 | 77 | 46 |
31 | 54 | 56 | 77 | 46 |
32 | 56 | 56 | 77 | 46 |
33 | 56 | 58 | 77 | 46 |
34 | 56 | 58 | 77 | 46 |
35 | 56 | 59 | 77 | 46 |
36 | 56 | 59 | 77 | 46 |
37 | 57 | 61 | 77 | 46 |
38 | 57 | 62 | 77 | 46 |
39 | 59 | 62 | 77 | 46 |
40 | 58 | 63 | 76 | 45 |
41 | 58 | 63 | 76 | 45 |
42 | 59 | 63 | 76 | 45 |
43 | 59 | 65 | 76 | 45 |
44 | 61 | 65 | 76 | 45 |
45 | 61 | 66 | 76 | 45 |
46 | 62 | 66 | 76 | 45 |
47 | 62 | 66 | 76 | 45 |
48 | 64 | 68 | 76 | 45 |
49 | 64 | 68 | 76 | 45 |
50 | 66 | 68 | 76 | 45 |
51 | 66 | 69 | 78 | 45 |
52 | 66 | 69 | 78 | 45 |
53 | 67 | 69 | 78 | 45 |
54 | 67 | 71 | 78 | 46 |
55 | 67 | 71 | 78 | 46 |
56 | 67 | 72 | 78 | 46 |
57 | 69 | 72 | 78 | 46 |
58 | 69 | 72 | 78 | 46 |
59 | 69 | 74 | 78 | 46 |
60 | 69 | 74 | 78 | 46 |
1ThODNH4of Pepper black oil: 3.178 mg O2/mg test item | ||||
2ThODNH4of sodium benzoate: 1.666 mg O2/mg reference item |
Biodegradation in the Toxicity Control
In the toxicity control containing both, the test item and the reference item sodium benzoate, 37% biodegradation was noted within 14 days and 46% biodegradation after 28 days of incubation. According to the test guidelines, the test item can be assumed to be not inhibitory to the aerobic activated sludge microorganisms because degradation was >25% within 14 days.
Validity Criteria of the Study
- Inoculum Control: The oxygen demand of the inoculum control (medium and inoculum) was 27.5 mg O2/L and thus not greater than 60 mg O2/L within 28 days as required by the test guideline.
- pH-Value: The pH-value of the test item flasks at the end of the test was 7.4 and therefore within the range of pH 6.0 to 8.5 as required by the test guideline.
- Reference Item: The percentage degradation of the reference item should reach the level for ready biodegradability (>60%) within 14 days as required by the test guideline. The reference item sodium benzoate was degraded to more than 60% after 4 days of incubation.
- Test Item: The difference of duplicate values for the degradation of the test item at the end of the 10-day window (day 14), at day 28, at the plateau (day 59) and at the end of the test and was less than 20%. The difference of duplicate values was not greater than 5% for any time point.
- Toxicity Control: If in a toxicity test, containing both the test substance and a reference compound less than 25% biodegradation (based on total ThOD) occurred within 14 days, the test substance can be assumed to be inhibitory. The biodegradation was 37% at day 14; the test item was not inhibitory.
The validity criterion was fulfilled.
Description of key information
Based on an experimental study on Pepper black oil according to guidance OECD 301F, the substance is considered as not readily biodagradable.
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
Additional information
The test item Pepper black oil was investigated for its ready biodegradability in a manometric respirometry test over a period of 60 days according to the OECD 301F guideline. Pepper black oil is considered to be not readily biodegradable after 28 days, but reached a degradation of 72% after 60 days.
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