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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to microorganisms, other
Remarks:
Biodegradation in water: screening test, toxicity control is used to derive effect concentration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
Version / remarks:
1992
Deviations:
no
Principles of method if other than guideline:
From biodegradation in water: screening test, toxicity control is used to derive effect concentration
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
activated sludge, domestic
Details on inoculum:
- Name and location of sewage treatment plant where inoculum was collected: Kläranlage, Sunthelle 6, 57392 Schmallenberg, Germany
- Preparation of inoculum for exposure: kept aerobic and filtered through a coarse filter paper.
- Storage length: until use in the test, at least 1 h
- Concentration of sludge: 1 mL/L
Test type:
other: aerobic
Water media type:
other: mineral medium
Limit test:
no
Total exposure duration:
28 d
Test temperature:
20 (± 1 °C)
Details on test conditions:
TEST CONDITIONS
- Composition of medium: ( a ) KH 2 PO 4 8.50 g/L
K2HPO4 21.75 g/L
Na2HPO4 26.64 g/L
NH4Cl 0.51 g/L
( b ) CaCl2 x 2H2O 36.41 g/L
( c ) MgSO4 x 7H2O 22.50 g/L
( d ) FeCl3 x 6H2O 0.25 g/L.
The mineral medium applied in the test contained 1 mL/L of the mineral stock solution a–d, respectively. The mineral medium was strongly aerated for 20 minutes and allowed to stand for 20 h at test temperature.
- Test temperature: 20 °C (± 1 °C)
- Aeration of dilution water: yes
- Continuous darkness: yes

SAMPLING
- Sampling frequency: day 3*, 6, 10*, 14, 21*, and 28 (* without toxicity control) using an O 2 electrode.

CONTROL AND BLANK SYSTEM
- Inoculum blank: 16 vessels containing only inoculum
- Toxicity control: 8 vessels containing test item (40 mg/L), reference item (2 mg/L) and inoculum

STATISTICAL METHODS:
Theoretical Oxygen Demand (ThOD):
The Theoretical Oxygen Demand (ThOD) was calculated on the basis of the sum formula of the test and reference item considering complete nitrification.
Biochemical Oxygen Demand (BOD):
The Biochemical Oxygen Demand (BOD) was calculated on the basis of the test raw data by BOD [mg/mg] = mg O2 uptake corrected by blank per mg test item.
The percent degradation was calculated according to the following formula:
D t = [(C t –C b ) / ThOD] x 100
D t : degradation (%) at time t;
C t : mean oxygen consumption (mg/L) in the test suspension at time t;
C b : mean oxygen consumption (mg/L) in the blanks at time t;
ThOD: Theoretical oxygen demand of the test suspension (mg/L).
Reference substance (positive control):
yes
Remarks:
sodium benzoate
Key result
Duration:
14 d
Dose descriptor:
other: % degradation (O2 consumption)
Effect conc.:
26 other: %
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
inhibition of heterotrophic respiration
Remarks on result:
other: O2 consumption after 14 days
Details on results:
- Blank controls oxygen uptake rate: O2 consumption/ % degradation after 14 d 96.9% within the procedural control.
Results with reference substance (positive control):
The biodegradation of sodium benzoate was 87.4% after 28 days.
Validity criteria fulfilled:
not applicable
Conclusions:
In a study concucted according to OECD guideline 301D 1992, the toxicity of hydrogenated tallow/nortallow based IQAC to microorganisms was determined. The test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 40 mg/L.
Executive summary:

The toxicity of hydrogenated tallow/nortallow based IQAC to microorganisms was investigated during a ready biodegradation study according to EU Method C.4-D (2008) and OECD guideline 301D (1992), Closed Bottle Test over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with 20 and 40 mg/L test item and 2 mg/L reference item Sodium benzoate were performed.

The reference item degraded normally (87.4 % by within 28 days).

The biodegradation of the item mixture in the toxicity control was found to be 75.5 % after 14 days of incubation. Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 40 mg/L, as the biodegradation in the toxicity control was higher than 25% within 14 days of incubation.

Description of key information

- study conducted according to OECD guideline 301 D (Closed Bottle Test), domestic sewage treatment plant sludge was incubated with 40 mg/L test item and 2 mg/L reference item, after 14 days degradation was > 25%, thus the substance is not inhibitory.

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
40 mg/L

Additional information

The biodegradation of hydrogenated tallow/nortallow based IQAC, aqueous dispersion (5% ) was investigated over a 28-day period in a Closed Bottle Test according to OECD guideline 301 D (1992). The test medium was inoculated with activated sludge from a sewage treatment plant mainly fed with municipal wastewater. The rate of degradation was monitored by measuring the oxygen consumption over the 28-d period.

The test item was tested with a concentration of 20 and 40 mg/L in duplicates, corresponding to a carbon content (ThOC) of 2.83 and 5.66 mg C/L in the test vessels.

Degradation is followed by analysis of dissolved oxygen over a 28-day period. The amount of oxygen taken up by the microbial population during biodegradation of the test item (corrected for uptake by blank inoculum, run in parallel) is expressed as a percentage of ThOD.

The 10 % level (beginning of biodegradation of the test item) was reached within an adaptation phase of 3 days for the procedural control. The percentage of degradation of the functional control reached the pass level of 60 % after 3 days.

The highest mean biodegradation rate of hydrogenated tallow/nortallow based IQAC aqueous dispersion (5 %) within the 28 days of incubation in the static test was found to be 6 % (day 6) in the assays with 20 mg/L and 3 % (day 21) in the assays with 40 mg/L. Thus, no biodegradation within a 10-day-window could be obtained. The biodegradation of the item mixture in the toxicity control was found to be 26 % after 14 days of incubation. Thus, the demanded threshold value of 25 % is exceeded and the test item hydrogenated tallow/nortallow based IQAC, aqueous dispersion (5 %) can be identified as non-toxic in a ready biodegradability test. The reference item sodium benzoate was degraded to 97 % within the first 14 days, which was the highest degradation rate found within the test duration. In conclusion, according to the guideline, the test item hydrogenated tallow/nortallow based IQAC aqueous dispersion (5 %) must be identified as not readily biodegradable under the chosen test conditions.