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EC number: 282-025-9 | CAS number: 84082-79-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Salvia officinalis, Labiatae.
- 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 2017-12-08 to 2018-04-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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 relevant.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Signed on March 2017
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Details on inoculum:
- - Species/Origin: Aerobic activated sludge, microorganisms from a domestic waste water treatment plant was supplied by the sewage treatment plant Rossdorf, Germany.
- Conditioning: The aerobic activated sludge used for this study was set to deposit for 15 minutes, then washed by centrifugation and the supernatant liquid phase was decanted. The solid material was re-suspended 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.:
- 102.9 mg/L
- Based on:
- test mat.
- Remarks:
- Corresponding to 306.8 mg/L (ThODNH4)
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Aliquots of washed sludge suspension, corresponding to 3.5 g dry material per litre were mixed with test water and aerated overnight.
- 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 AR 20 at a concentration of about 1% of the final flask volume were added to all flasks in order to improve the bioavailability of the mixture constituents.
- Test temperature: 22°C ± 1°C
- pH: 8.0 (measured at the start of the test and adjusted to pH 7.6 with Hydrochloric Acid), 7.2 to 7.6 (measured at the end of the test)
- 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:
- benzoic 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:
- 60
- Sampling time:
- 35 d
- Parameter:
- % degradation (O2 consumption)
- Remarks:
- ThODNH4
- Value:
- 72
- Sampling time:
- 60 d
- Details on results:
- The mean biodegradation of 10% of Sage dalmatian oil was reached at day 4 (ThODNH4). At the end of the 10-day window at day 14, the mean degradation of Sage dalmatian oil was 34% (ThODNH4) and therefore the 10 day window criterion was not passed. After 28 days the mean biodegradation was 53% (ThODNH4) and the test was prolonged until day 60. Therefore, Sage dalmatian oil is considered to be not readily biodegradable based on ThODNH4. Still 72% were reached 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 86% after 14 days, to 94% after 28 and 108% after 60 days of incubation, thus confirming the suitability of the aerobic activated sludge inoculum used.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Sage Dalmaian oil is considered to be not readily biodegradable after 28 days, bu reached a degradation of 72% after 60 days.
- Executive summary:
The test item Sage dalmatian oil was investigated for its ready biodegradability in a manometric respirometry test over a period of 60 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 mean biodegradation of 10% of Sage dalmatian oil was reached at day 4 (ThODNH4). At the end of the 10-day window at day 14, the mean degradation of Sage dalmatian oil was 34% (ThODNH4) and therefore the 10 day window criterion was not passed.Due to the fact that the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally similar constituents, the 10-day window condition may be waived and the pass level applied at 28 days according to section 4.1.2.9.5 of CLP COMMISSION REGULATION (EU) No 286/2011 of 10 March 2011. After 28 days the mean biodegradation was 53% (ThODNH4) and the test was prolonged until day 60. The mean biodegradation at test end after 60 days was 72% (ThODNH4).
Therefore, Sage dalmatian oil is considered to be not readily biodegradable based on ThODNH4. Still 72% were reached after 60 days.
Validity criteria:
The oxygen demand of the inoculum control (medium and inoculum) was 25 mg O2/L and thus not greater than 60 mg O2/L within 60 days as required by the test guideline. The pH-value of the test item flasks at the end of the test were 7.5 and 7.4, and therefore within the range of pH 6.0 to 8.5 as required by the atest guideline. 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. The difference of duplicate values for the degradation of the test item at the end of the test was less than 20%. The difference of duplicate values at day 60 differed by 1%.
The validity criterion was fulfilled.
Reference
pH-Values at the End of the Test
Flask No. |
Treatment |
pH-value |
1 |
Sage dalmatian oil |
7.5 |
2 |
Sage dalmatian oil |
7.4 |
3 |
Inoculum control |
7.2 |
4 |
Inoculum control |
7.2 |
5 |
Reference item (procedure control) |
7.6 |
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 |
60 |
0 |
60 |
|
2 |
5 |
5 |
5 |
0 |
75 |
0 |
80 |
|
3 |
30 |
30 |
5 |
0 |
95 |
0 |
100 |
|
4 |
50 |
50 |
10 |
5 |
120 |
0 |
125 |
|
5 |
55 |
65 |
10 |
5 |
130 |
0 |
135 |
|
6 |
75 |
75 |
15 |
10 |
140 |
0 |
145 |
|
7 |
80 |
80 |
15 |
10 |
145 |
0 |
155 |
|
8 |
90 |
85 |
15 |
10 |
150 |
0 |
165 |
|
9 |
95 |
90 |
15 |
15 |
155 |
0 |
180 |
|
10 |
105 |
105 |
15 |
15 |
155 |
0 |
195 |
|
11 |
105 |
110 |
15 |
15 |
160 |
0 |
205 |
|
12 |
110 |
110 |
20 |
15 |
160 |
0 |
215 |
|
13 |
115 |
115 |
20 |
15 |
160 |
0 |
225 |
|
14 |
120 |
125 |
20 |
15 |
165 |
0 |
235 |
|
15 |
125 |
130 |
20 |
15 |
165 |
0 |
245 |
|
16 |
130 |
135 |
20 |
15 |
165 |
0 |
245 |
|
17 |
135 |
140 |
20 |
15 |
170 |
0 |
250 |
|
18 |
140 |
145 |
20 |
15 |
170 |
0 |
255 |
|
19 |
140 |
150 |
25 |
15 |
175 |
0 |
260 |
|
20 |
145 |
155 |
25 |
20 |
180 |
0 |
265 |
|
21 |
150 |
160 |
25 |
20 |
180 |
0 |
270 |
|
22 |
155 |
165 |
25 |
20 |
185 |
0 |
275 |
|
23 |
160 |
170 |
25 |
20 |
185 |
0 |
280 |
|
24 |
170 |
175 |
25 |
20 |
185 |
0 |
280 |
|
25 |
170 |
180 |
25 |
20 |
185 |
0 |
280 |
|
26 |
170 |
185 |
25 |
20 |
185 |
0 |
285 |
|
27 |
175 |
190 |
25 |
20 |
185 |
0 |
285 |
|
28 |
175 |
195 |
25 |
20 |
185 |
0 |
290 |
|
29 |
180 |
200 |
30 |
20 |
190 |
0 |
290 |
|
30 |
185 |
205 |
30 |
20 |
190 |
0 |
295 |
|
31 |
190 |
205 |
30 |
20 |
190 |
0 |
295 |
|
32 |
195 |
210 |
30 |
20 |
190 |
0 |
295 |
|
33 |
195 |
215 |
30 |
20 |
190 |
0 |
295 |
|
34 |
200 |
215 |
30 |
20 |
195 |
0 |
295 |
|
35 |
200 |
225 |
30 |
20 |
195 |
0 |
295 |
|
36 |
205 |
225 |
30 |
20 |
195 |
0 |
295 |
|
37 |
210 |
225 |
30 |
20 |
195 |
0 |
295 |
|
38 |
215 |
225 |
30 |
20 |
195 |
0 |
295 |
|
39 |
220 |
225 |
30 |
20 |
195 |
0 |
295 |
|
40 |
220 |
230 |
30 |
20 |
195 |
0 |
295 |
|
41 |
225 |
230 |
30 |
20 |
200 |
0 |
295 |
|
42 |
225 |
230 |
30 |
20 |
200 |
0 |
295 |
|
43 |
230 |
230 |
30 |
20 |
200 |
0 |
295 |
|
44 |
230 |
235 |
30 |
20 |
200 |
0 |
295 |
|
45 |
230 |
240 |
30 |
20 |
200 |
0 |
295 |
|
46 |
230 |
240 |
30 |
20 |
200 |
0 |
295 |
|
47 |
230 |
240 |
30 |
20 |
200 |
0 |
295 |
|
48 |
230 |
240 |
30 |
20 |
200 |
0 |
295 |
|
49 |
230 |
240 |
30 |
20 |
200 |
0 |
295 |
|
50 |
235 |
240 |
30 |
20 |
200 |
0 |
295 |
|
51 |
235 |
240 |
30 |
20 |
200 |
0 |
295 |
|
52 |
235 |
245 |
30 |
20 |
205 |
0 |
295 |
|
53 |
240 |
245 |
30 |
20 |
205 |
0 |
295 |
|
54 |
240 |
245 |
30 |
20 |
210 |
0 |
295 |
|
55 |
240 |
245 |
30 |
20 |
210 |
0 |
295 |
|
56 |
240 |
245 |
30 |
20 |
210 |
0 |
295 |
|
57 |
240 |
245 |
30 |
20 |
210 |
0 |
295 |
|
58 |
240 |
245 |
30 |
20 |
210 |
0 |
295 |
|
59 |
245 |
245 |
30 |
20 |
210 |
0 |
295 |
|
60 |
245 |
245 |
30 |
20 |
210 |
0 |
295 |
|
Flasks 1 and 2: Sage dalmatian 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) |
Sage dalmatian oil1 |
Sodium Benzoate2 |
Toxicity |
|
|
Flask 1 [%] |
Flask 2 [%] |
Flask 5 [%] |
Flask 7 [%] |
1 |
0 |
0 |
35 |
13 |
2 |
1 |
1 |
42 |
16 |
3 |
9 |
9 |
54 |
21 |
4 |
14 |
14 |
65 |
25 |
5 |
15 |
19 |
71 |
27 |
6 |
20 |
21 |
74 |
28 |
7 |
22 |
22 |
77 |
30 |
8 |
25 |
24 |
80 |
32 |
9 |
26 |
25 |
81 |
35 |
10 |
29 |
30 |
81 |
38 |
11 |
29 |
31 |
84 |
40 |
12 |
30 |
30 |
83 |
42 |
13 |
32 |
32 |
83 |
44 |
14 |
33 |
35 |
86 |
46 |
15 |
35 |
37 |
86 |
48 |
16 |
36 |
39 |
86 |
48 |
17 |
38 |
40 |
89 |
49 |
18 |
40 |
42 |
89 |
50 |
19 |
39 |
43 |
90 |
51 |
20 |
40 |
44 |
92 |
51 |
21 |
41 |
45 |
92 |
52 |
22 |
43 |
47 |
94 |
53 |
23 |
44 |
48 |
94 |
54 |
24 |
48 |
50 |
94 |
54 |
25 |
48 |
52 |
94 |
54 |
26 |
48 |
53 |
94 |
55 |
27 |
49 |
55 |
94 |
55 |
28 |
49 |
57 |
94 |
56 |
29 |
50 |
58 |
96 |
56 |
30 |
52 |
59 |
96 |
57 |
31 |
53 |
59 |
96 |
57 |
32 |
55 |
61 |
96 |
57 |
33 |
55 |
62 |
96 |
57 |
34 |
57 |
62 |
99 |
57 |
35 |
57 |
66 |
99 |
57 |
36 |
58 |
66 |
99 |
57 |
37 |
60 |
66 |
99 |
57 |
38 |
61 |
66 |
99 |
57 |
39 |
63 |
66 |
99 |
57 |
40 |
63 |
67 |
99 |
57 |
41 |
65 |
67 |
102 |
57 |
42 |
65 |
67 |
102 |
57 |
43 |
66 |
67 |
102 |
57 |
44 |
66 |
69 |
102 |
57 |
45 |
66 |
71 |
102 |
57 |
46 |
66 |
71 |
102 |
57 |
47 |
66 |
71 |
102 |
57 |
48 |
66 |
71 |
102 |
57 |
49 |
66 |
71 |
102 |
57 |
50 |
68 |
71 |
102 |
57 |
51 |
68 |
71 |
102 |
57 |
52 |
68 |
72 |
105 |
57 |
53 |
70 |
72 |
105 |
57 |
54 |
70 |
72 |
108 |
57 |
55 |
70 |
72 |
108 |
57 |
56 |
70 |
72 |
108 |
57 |
57 |
70 |
72 |
108 |
57 |
58 |
70 |
72 |
108 |
57 |
59 |
71 |
72 |
108 |
57 |
60 |
71 |
72 |
108 |
57 |
1ThODNH4of Sage dalmatian oil: 2.982 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, 46% biodegradation was noted within 14 days, 56% biodegradation after 28 days and 57% biodegradation after 60 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.
Abiotic Control
The oxygen demand in the abiotic control was 0 mg/L during the test duration. There was no use to correct the degradation of the test item and toxicity control.
Validity criteria
Inoculum Control: |
The oxygen demand of the inoculum control (medium and inoculum) was 25 mg O2/L and thus not greater than 60 mg O2/L within 60 days as required by the test guideline. |
pH-Value: |
The pH-value of the test item flasks at the end of the test were 7.5 and 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 test was less than 20%. The difference of duplicate values at day 60 differed by 1%. The validity criterion was fulfilled. |
Description of key information
According to the test guideline, the registered substance is considered not readily biodegradable because the biodegradation was 53% after 28 days. Nevertheless, the biodegradation reached 72% after 60 days of test.
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
- Type of water:
- freshwater
Additional information
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