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EC number: 268-859-6 | CAS number: 68152-93-2
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- 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
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Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil microorganisms
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021 - 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
- Version / remarks:
- adopted January 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- The following information concerning identity and composition of the test item was provided by the sponsor.
Name: Tall oil, maleated
CAS no.: 68152-93-2
EC no.: 268-859-6
Copy of Certificate of Analysis is attached to study report
Storage in Test Facility: The test item was stored in the test facility in a closed vessel at room temperature (20 ±5 °C), kept under inert gas. - Analytical monitoring:
- yes
- Remarks:
- The analytical determination of nitrate was performed via IC following SANCO/3029/99 rev. 4 dated 11. July 2000.
- Vehicle:
- no
- Details on preparation and application of test substrate:
- For determination of the microbial biomass, 8 samples were taken from the soil. Four samples, each 10.0 g, were extracted using 0.5 M K2SO4 solution, shaken for 1 hour, centrifuged for 10 min (4500 rpm), filtered through nylon filter and the TOC (total organic carbon) of the filtrated solution was measured. The water content of the soil at this time point was measured.
Then, the 4 other samples, each 20.0 g, were fumigated using chloroform for 4 days and then extracted as described above. The water content of each sample was measured.
TOC Measurement: Analyses of the dissolved organic carbon were made by TC and IC measurement using the carbon analyser TOC multi N/C 2100S, Analytik Jena. Each sample was measured in duplicate or triplicate, respectively (depending on the variation between the measured values). The carbon analyser was calibrated every 6 months with freshly prepared reference solutions containing potassium hydrogen phthalate (TC), sodium hydrogen carbonate and sodium carbonate (IC). The quality control samples were measured on each measurement day. TOC (Total organic carbon) is determined as TC (total carbon) minus IC (inorganic carbon) stock solution. - Test organisms (inoculum):
- soil
- Total exposure duration:
- 28 d
- Test temperature:
- Temperature during study performance: 19.5 – 21.2 °C
- Moisture:
- Water holding capacity of soil was 35.2 % ±1.8%. Demineralised water was used to adjust the soil to a water content of 40 to 60 % of the maximum water holding capacity.
- Organic carbon content (% dry weight):
- 0.65
- Nitrogen content (% dry weight):
- 0.07
- Nominal and measured concentrations:
- 10, 32, 100, 320 and 1000 mg/kg dry weight (nominal) were measured. The concentrations to be tested were based on a non GLP pre-test.
- Reference substance (positive control):
- no
- Duration:
- 28 d
- Dose descriptor:
- EC50
- Effect conc.:
- 754.98 mg/kg soil dw
- 95% CI:
- > 545.71 - <= 1 044.52
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- nitrate formation rate
- Details on results:
- see below in tables
- Results with reference substance (positive control):
- no positive control measured
- Reported statistics and error estimates:
- see below
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 28d-EC50 for nitrate formation inhibition was determined as 754.98 mg/kg dw (confidence interval 545.71 – 1044.52 mg/kg dw).
- Executive summary:
One valid experiment was performed in this OECD 216 study to determine inhibition of nitrate formation through terrestrial microorganisms. The study was performed using 5 concentrations ranging from 10 to 1000 mg/kg nominal.
Sieved soil was exposed to the test item for 28 days. After 0 and 28 days, the nitrate content of the soil of each treatment was determined using IC-determination. A blank and solvent control was tested. Because of no significant difference between the blank and solvent control, both controls were pooled for the statistical determination.
The two highest test concentrations showed inhibition of nitrate production compared to the pooled controls.
The relative standard deviation between the replicates of the pooled controls was 3.2 % and indicated a small difference between the replicates. No observations were made which might cause doubts concerning the validity of the study outcome. Thus, the result of the test can be considered valid. No deviations from the Study Plan were recorded.
In deviation from the guidelines, the soil was stored in the laboratory under test conditions. As the storage takes place in the dark and without air contact, this deviation can be stated as uncritical.
Inhibition of nitrate formation was only seen at elevated concentrations and the 28d EC50 in this study was found as 754.98 mg/kg soil dw.
Reference
Analytical Determination
The nitrate content of the replicates was measured at the start and the end of the test via IC-determination. The measured concentrations for treatments and controls are given in the following tables:
Table Measured Nitrate Concentrations at 0 d
Nominal Concentration [mg/kg] | Replicate | Area [mAU*min] | Measured Concentration [mg/L] | QC recovery [%] | Calculated Concentration [mg/L] | Mean Calculated Concentration [mg/L] |
QC sample (20 mg/L) | -- | 10.1548 | 20.1 | 100.7 | -- | -- |
-- | 10.1731 | 20.2 | 100.9 | -- | ||
Blank control | 1 | 6.6180 | 13.3 | -- | 13.3 | 13.31 |
6.6016 | 13.3 | -- | 13.3 | |||
2 | 6.2484 | 12.6 | -- | 12.6 | 12.38 | |
6.0101 | 12.1 | -- | 12.1 | |||
3 | 6.1730 | 12.5 | -- | 12.5 | 12.46 | |
6.1678 | 12.5 | -- | 12.5 | |||
Solvent control | 4 | 6.0681 | 12.3 | -- | 12.3 | 12.26 |
6.0640 | 12.3 | -- | 12.3 | |||
5 | 5.9662 | 12.1 | -- | 12.1 | 12.06 | |
5.9586 | 12.0 | -- | 12.0 | |||
6 | 5.9705 | 12.1 | -- | 12.1 | 12.07 | |
5.9733 | 12.1 | -- | 12.1 | |||
10 | 7 | 5.9958 | 12.1 | -- | 12.1 | 12.14 |
6.0115 | 12.2 | -- | 12.2 | |||
8 | 6.0422 | 12.2 | -- | 12.2 | 12.21 | |
6.0438 | 12.2 | -- | 12.2 | |||
9 | 6.0782 | 12.3 | -- | 12.3 | 12.26 | |
6.0568 | 12.2 | -- | 12.2 | |||
32 | 10 | 5.9228 | 12.0 | -- | 12.0 | 12.00 |
5.9420 | 12.0 | -- | 12.0 | |||
11 | 6.0115 | 12.2 | -- | 12.2 | 12.15 | |
6.0078 | 12.1 | -- | 12.1 | |||
12 | 5.9273 | 12.0 | -- | 12.0 | 11.98 | |
5.9152 | 12.0 | -- | 12.0 | |||
QC sample (20 mg/L) | -- | 10.1285 | 20.1 | 100.5 | -- | -- |
-- | 10.1548 | 20.1 | 100.7 | -- | -- | |
100 | 13 | 5.7628 | 11.7 | -- | 11.7 | 11.66 |
5.7556 | 11.7 | -- | 11.7 | |||
14 | 5.9821 | 12.1 | -- | 12.1 | 11.91 | |
5.7910 | 11.7 | -- | 11.7 | |||
15 | 5.7327 | 11.6 | -- | 11.6 | 11.62 | |
5.7355 | 11.6 | -- | 11.6 | |||
320 | 16 | 5.9173 | 12.0 | -- | 12.0 | 11.96 |
5.9044 | 11.9 | -- | 11.9 | |||
17 | 5.8761 | 11.9 | -- | 11.9 | 11.91 | |
5.9004 | 11.9 | -- | 11.9 | |||
18 | 5.8975 | 11.9 | -- | 11.9 | 11.93 | |
5.8933 | 11.9 | -- | 11.9 | |||
1000 | 19 | 5.7464 | 11.6 | -- | 11.6 | 11.64 |
5.7488 | 11.6 | -- | 11.6 | |||
20 | 5.7476 | 11.6 | -- | 11.6 | 11.64 | |
5.7483 | 11.6 | -- | 11.6 | |||
21 | 5.7329 | 11.6 | -- | 11.6 | 11.61 | |
5.7334 | 11.6 | -- | 11.6 | |||
QC sample (20 mg/L) | -- | 10.1457 | 20.1 | 100.6 | -- | -- |
-- | 10.1461 | 20.1 | 100.6 | -- |
LOQ = 2.5 mg/L
Table Measured Nitrate Concentrations at 28 d
Nominal Concentration [mg/kg] | Replicate | Area [mAU*min] | Measured Concentration [mg/L] | QC recovery [%] | Calculated Concentration [mg/L] | Mean Calculated Concentration [mg/L] |
QC sample (20 mg/L) | -- | 10.2091 | 20.2 | 101.2 | -- | -- |
-- | 10.2192 | 20.3 | 101.3 | -- | ||
Blank control | 1 | 8.8222 | 17.6 | -- | 17.6 | 17.57 |
8.8216 | 17.6 | -- | 17.6 | |||
2 | 8.5323 | 17.0 | -- | 17.0 | 17.02 | |
8.5432 | 17.0 | -- | 17.0 | |||
3 | 9.2141 | 18.3 | -- | 18.3 | 18.35 | |
9.2419 | 18.4 | -- | 18.4 | |||
Solvent control | 4 | 9.0431 | 18.0 | -- | 18.0 | 17.97 |
9.0121 | 17.9 | -- | 17.9 | |||
5 | 9.0190 | 18.0 | -- | 18.0 | 17.95 | |
9.0187 | 18.0 | -- | 18.0 | |||
6 | 8.4716 | 16.9 | -- | 16.9 | 16.94 | |
8.5172 | 17.0 | -- | 17.0 | |||
10 | 7 | 9.3841 | 18.7 | -- | 18.7 | 18.65 |
9.3802 | 18.6 | -- | 18.6 | |||
8 | 9.1583 | 18.2 | -- | 18.2 | 18.23 | |
9.1719 | 18.2 | -- | 18.2 | |||
9 | 9.7484 | 19.4 | -- | 19.4 | 19.37 | |
9.7570 | 19.4 | -- | 19.4 | |||
32 | 10 | 10.7647 | 21.3 | -- | 21.3 | 21.32 |
10.7703 | 21.3 | -- | 21.3 | |||
11 | 10.7536 | 21.3 | -- | 21.3 | 21.29 | |
10.7460 | 21.3 | -- | 21.3 | |||
12 | 10.6819 | 21.2 | -- | 21.2 | 21.16 | |
10.6787 | 21.2 | -- | 21.2 | |||
QC sample (20 mg/L) | -- | 10.2959 | 20.4 | 102.1 | -- | -- |
-- | 10.2974 | 20.4 | 102.1 | -- | -- | |
100 | 13 | 13.5011 | 26.6 | -- | 26.6 | 26.59 |
13.4929 | 26.6 | -- | 26.6 | |||
14 | 13.1666 | 26.0 | -- | 26.0 | 25.90 | |
13.1137 | 25.8 | -- | 25.8 | |||
15 | 13.1602 | 25.9 | -- | 25.9 | 25.96 | |
13.1865 | 26.0 | -- | 26.0 | |||
320 | 16 | 8.8398 | 17.6 | -- | 17.6 | 17.62 |
8.8544 | 17.6 | -- | 17.6 | |||
17 | 8.3302 | 16.6 | -- | 16.6 | 16.62 | |
8.3269 | 16.6 | -- | 16.6 | |||
18 | 8.6096 | 17.2 | -- | 17.2 | 17.16 | |
8.6038 | 17.2 | -- | 17.2 | |||
1000 | 19 | 3.6060 | 7.5 | -- | 7.5 | 7.51 |
3.6020 | 7.5 | -- | 7.5 | |||
20 | 3.3319 | 7.0 | -- | 7.0 | 6.98 | |
3.3317 | 7.0 | -- | 7.0 | |||
21 | 3.4315 | 7.2 | -- | 7.2 | 7.18 | |
3.4340 | 7.2 | -- | 7.2 | |||
QC sample (20 mg/L) | -- | 10.2653 | 20.4 | 101.8 | -- | -- |
-- | 10.2620 | 20.3 | 101.7 | -- |
LOQ = 2.5 mg/L
Nitrate Concentration
The nitrate concentration at the start and the end of the test in mg/kg is stated in the following table.
Table Nitrate Concentration
Nominal Concentration in mg/kg dry matter | Replicate | Nitrate Concentration in mg/kg at day 0 | Nitrate Concentration in mg/kg at day 28 |
Blank control | 1 | 131.57 | 173.97 |
2 | 122.37 | 168.53 | |
3 | 123.17 | 181.70 | |
Mean | 125.70 | 174.73 | |
SD | 5.09 | 6.62 | |
RSD | 4.1 | 3.8 | |
Solvent control | 4 | 121.23 | 178.04 |
5 | 119.26 | 177.84 | |
6 | 119.36 | 167.84 | |
Mean | 119.95 | 174.57 | |
SD | 1.11 | 5.84 | |
RSD | 0.9 | 3.3 | |
10 | 7 | 120.24 | 185.28 |
8 | 120.93 | 181.11 | |
9 | 121.42 | 192.43 | |
Mean | 120.86 | 186.27 | |
SD | 0.60 | 5.73 | |
RSD | 0.5 | 3.1 | |
32 | 10 | 118.86 | 210.13 |
11 | 120.35 | 209.84 | |
12 | 118.67 | 208.56 | |
Mean | 119.29 | 209.51 | |
SD | 0.92 | 0.84 | |
RSD | 0.8 | 0.4 | |
100 | 13 | 115.44 | 262.94 |
14 | 117.91 | 256.12 | |
15 | 115.04 | 256.71 | |
Mean | 116.13 | 258.59 | |
SD | 1.56 | 3.78 | |
RSD | 1.34 | 1.46 | |
320 | 16 | 118.29 | 174.89 |
17 | 117.80 | 164.96 | |
18 | 117.99 | 170.32 | |
Mean | 118.03 | 170.06 | |
SD | 0.25 | 4.97 | |
RSD | 0.21 | 2.92 | |
1000 | 19 | 115.11 | 74.52 |
20 | 115.11 | 69.26 | |
21 | 114.81 | 71.24 | |
Mean | 115.01 | 71.67 | |
SD | 0.17 | 2.66 | |
RSD | 0.15 | 3.71 |
SD = Standard Deviation
RSD = Relative Standard Deviation
Inhibition of Nitrate Production: In lack of significant difference between the blank and solvent control, both controls were pooled for the statistical determination. The mean and SD of inhibition of nitrate production per concentration in % compared to the pooled controls are stated in the table below.
Table Nitrate production in % compared to the pooled controls
Nominal Concentration in mg/kg dry matter | Mean inhibition of nitrate production in % compared to the pooled controls |
Pooled controls | -- |
10 | - 6.0 |
32 | - 21.1 |
100 | - 48.5 |
320 | 3.0 |
1000 | 59.1 |
Negative inhibition values indicate a stimulation of nitrate production compared to the pooled controls.
Statistics and Biological Results: Calculation of results was performed with the help of validated software (Microsoft Excel®). The estimation of the biological data was accomplished using the software ToxRat® Professional, version 3.3.0.
The following results were determined: 28d-EC50: 750.10 mg/kg (confidence interval 538.67 mg/kg – 1044.50 mg/kg; This value was extrapolated by the program)
Description of key information
One valid experiment was performed according to OECD 216 investigating tall oil, maleated.
The study was performed using 5 concentrations ranging from 10 to 1000 mg/kg nominal. Sieved soil was exposed to the test item for 28 days. After 0 and 28 days, the nitrate content of the soil of each treatment was determined using IC-determination. A blank and solvent control were tested. Because of no significant difference between the blank and solvent control, both controls were pooled for the statistical determination.
The two highest test concentrations (320 and 1000 mg/kg soil dw) showed inhibition of nitrate production compared to the pooled controls. The following results were determined for the test item Tall oil, maleated: 28d-EC50 = 754.98 mg/kg dw (confidence interval 538.67 mg/kg – 1044.50 mg/kg).
Key value for chemical safety assessment
- Short-term EC50 for soil microorganisms:
- 754.98 mg/kg soil dw
Additional information
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