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Ecotoxicological information

Toxicity to microorganisms

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Endpoint:
toxicity to microorganisms, other
Remarks:
ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
23. Aug. 2007 - 24. Apr. 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
other: OECD 301B
Version / remarks:
The results of the test on ready biodegradability were used in a weight of evidence approach for the derivation of the PNEC STP
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: Probe vom 07.08.2007
- Expiration date of the batch: 09.08.2008

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored at room temperature in the dark.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no
Analytical monitoring:
yes
Vehicle:
no
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
- Laboratory culture:
- Name and location of sewage treatment plant where inoculum was collected: The sludge was taken from the activation basin of the ESN (Stadtentsorgung Neustadt) sewage treatment plant, 1m Altenschemel, NW-Lachen-Speyerdorf
- Pretreatment: The sludge was filtrated , washed with tap water twice, then washed with and re-suspended in test medium. It was then aerated until use.
- Initial biomass concentration: The dry matter was determined with 4860 mg suspended solids/litre.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Test temperature:
22 ± 2°'C
pH:
7.4 +/- 0.1
Nominal and measured concentrations:
37.1 mg/L (mean of two concentrations), corresponding to an organic carbon content of 20 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 1500 ml glass flasks
- Type (delete if not applicable): open



Inoculum concentration:
Temperature:
Duration: 28 days





- No. of vessels per concentration (replicates): 2, containing test item, mineral medium and inoculum
- No. of vessels per control (replicates): 2, containing mineral medium and inoculum
- No. of vessels per toxicity control (replicates): 1, containing test item, reference item, mineral medium and inoculum
- No. of vessels per abiotic control (replicates): 1, containing test item, mineral medium and HgCI2
- Sludge concentration (weight of dry solids per volume): 24.9 mg suspended solids/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Particulate matter:
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:
- Details on termination of incubation:
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using fewer concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
anilin
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
37.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: CO2 evolution
Validity criteria fulfilled:
yes
Conclusions:
Polysolvan O is readily biodegradable according to the definition of the OECD 301B. As no toxic effects of the test substance to the inoculum were observed during the exposure time of 28 days, the results of this test can be used for assessing the toxicity to microorganisms in a weight of evidence approach.
Endpoint:
toxicity to microorganisms
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
Deviations:
yes
Remarks:
The exposure period was 18 hours, not 16 hours as mentioned in the guideline
Principles of method if other than guideline:
Toxicity to Pseudomonas putida was determined in two different ways: In the first approach, toxic effects were determined by means of the commonly used growth inhibition test according to DIN 38 412 as described in doc no T01697. In the second approach, toxic effects on Pseudomonas putida were determined by means of ATP measurement.
GLP compliance:
not specified
Analytical monitoring:
not specified
Details on sampling:
as described in T01697
Vehicle:
not specified
Details on test solutions:
The nutrient media were prepared according to the method described in T01697, however, the pre-culture medium contained 50 mg/L yeast extract instead of trace element and vitamin solution.
Test organisms (species):
Pseudomonas putida
Details on inoculum:
as described in T01697
Test type:
static
Water media type:
freshwater
Total exposure duration:
18 h
Nominal and measured concentrations:
Nominal concentrations are given
Details on test conditions:
Type: aquatic
Reference substance (positive control):
not specified
Duration:
18 h
Dose descriptor:
EC10
Effect conc.:
454 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: standard test
Duration:
18 h
Dose descriptor:
EC50
Effect conc.:
2 320 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: standard test
Duration:
3 h
Dose descriptor:
EC10
Effect conc.:
347 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: ATP measurement
Remarks on result:
other: ATP test
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
2 240 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: ATP measurement
Remarks on result:
other: ATP test
Details on results:
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
no reference substance was tested
Reported statistics and error estimates:
Effect concentrations were determined graphically by means of a dose-response curve. For the standard growth inhibition test, a coefficient of variation of 0.5 - 1% is given for the parallel replicates.
Validity criteria fulfilled:
not applicable
Executive summary:

The possible toxic effects of Polysolvan O to bacteria was tested with Pseudomonas putida in two different test approaches. In the first, the standard growth inhibition test according to DIN 38 412 part 8 was conducted were the effects were determined by photometrical determination of opacity. The second test was

Endpoint:
toxicity to microorganisms
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1 day
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is very poorly described, but it provides valuable information and meets accepted scientific standards. This present report was newly generated in 2009 from archived laboratory manuscripts of the year 1986.
Qualifier:
equivalent or similar to guideline
Guideline:
ETAD Fermentation Tube Method
GLP compliance:
no
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
anaerobic bacteria from a domestic water treatment plant
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
24 h
Details on test conditions:
Type: aquatic
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
2 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: reduction of gas production
Validity criteria fulfilled:
not specified
Remarks:
A validation of the results is not possible, as neither validation criteria were documented, nor the absolute values of the gas production activities were recorded.
Conclusions:
The EC0 of Polysolvan O in the fermentation tube test was 2500 mg/L.

Description of key information

Pseudomonas putida: EC10 (18 hr): 454 mg/l
Pseudomonas putida: EC50 (18 hr): 2320 mg/l
ETAD fermentation tube test: EC0 (24 hr): 2500 mg/l

Ready biodegradability: 37.1

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
37.1 mg/L

Additional information

No respitration inhibition test is available for Polysolvan O. But three studies are available which can be used for the assessment of the toxicity to microorganisms in a weight of evidence approach.. In the so-called ETAD fermentation tube test, the toxicity to microorganisms under anaerobic conditions was assessed. The EC0 was determined to be 2500 mg/L after an exposure period of 24 hours. The second study was conducted under aerobic conditions using Pseudomonas putida as model organism. The reported EC10 in this test was 454 mg/l after an exposure period of 18 h. The third study is a test on ready biodegradability of Polysolvan O. No toxic effects of the substance could be shown at a test concentration of 37.1 mg/L (i.e 20 mg organic carbon/L) which is the lowest value of any of the available study on toxicity to microorganisms. This study is a guideline study (OECD 301B) and was performed according to GLP and was hence considered to be the most reliable one. According to chapter 10 of the IR&CSR, a study on ready biodegradability can be used for the derivation of the PNEC for STP if not study on toxicity to microorganisms is available. Therefore, the NOEC derived from this study can be used for the development of the PNEC for microorganisms.