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EC number: 942-425-2 | CAS number: -
- 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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27 July 2016 to 02 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was performed according to OECD Guideline 209 with GLP statement. All validity criteria were fulfilled and no deviations were observed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected on 03-05 June 2013 / signed on 01 February 2016
- Specific details on test material used for the study:
- - Water solubility: not miscible
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
See table 6.1.7/1: Dilution table for the test item
- Control: Test medium without test or reference item - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Source: Municipal sewage treatment plant of 31137 Hildesheim, Germany.
- Pretreatment: The sludge was washed twice with chlorine free tap water and adjusted to a dry sludge concentration of 3.0 g/L ± 10 %. The sludge was used within 24 h after sampling.
- Dry sludge concentration: 2.71 g/L corresponding to 1.36 g/L in the test vessel - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Remarks on exposure duration:
- none
- Post exposure observation period:
- None
- Hardness:
- None
- Test temperature:
- nominal 18 - 22 °C, actually measured 19.1°C
- pH:
- - pH value of the activated sludge: 7.40
- pH value of the synthetic waste water: 7.27 - Dissolved oxygen:
- After 3 h incubation, the oxygen concentration of each control, reference item and test item replicate was determined by means of oximeter immediately after transferring the solution to the measuring cell and the oxygen depletion was recorded for at least 5 minutes on a flat bed recorder
- Salinity:
- No data
- Nominal and measured concentrations:
- 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 1000 mL Erlenmeyer flasks, DIN 12380
- Aeration: Shaking aeration, to keep the dissolved oxygen concentration above 60 - 70 % saturation and to maintain the sludge flakes in suspension. The flasks were closed with an active carbon trap that allows air exchange.
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6 (Triplicates at the beginning of the test + triplicates at the end of the test)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic waste water according to OECD Guideline 209
- Volume of the test medium: 500 mL
OTHER TEST CONDITIONS
- Adjustment of pH: Adjustment to 7.5 ± 0.5 was not necessary.
EFFECT PARAMETERS MEASURED
- The respiration rates of the control, reference and test item replicates were measured after a contact time of three hours, and the inhibitory effects of the test and reference item were determined in comparison to the control respiration rates.
TEST CONCENTRATIONS
A preliminary test (non GLP) was carried out with the following test item concentrations: 10 - 100 - 1000 mg/L with two replicates each and additionally two replicates with 1000 mg/L to study the inhibition of the nitrification using Allylthiourea ATU. The pH was not adjusted. The predicted Henrys Law Constant (25°C) [HENRYWIN v3.20] of 6.27E-005 atm-m3/mole (Bond Method) and 1.44E-004 atm-m3/mole (Group Method ), respectively, indicate a volatility that can be considered as close to non-volatile in practice. Nevertheless, the precautions mentioned in the guidelines (shaking aeration, direct pipetting) were taken. Based on the results of the preliminary test it can be concluded that the heterotrophic respiration as well as the nitrification are not inhibited. Therefore, the definitive study was carried out with the concentration of 1000 mg/L in 3 replicates (limit test to determine the NOEC). - Reference substance (positive control):
- yes
- Remarks:
- Copper (II) sulphate pentahydrate p.a.
- Key result
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Details on results:
- The mean inhibition of respiration for the test item replicates was 4% at 1000 mg/L.
The NOEC of the test substance is >= 1000 mg/L. The test substance caused no inhibiting effects on activated sludge of a municipal sewage treatment plant at the limit test item concentration of 1000 mg/L. No nitrification inhibition was observed at 1000 mg/L in the preliminary test and this endpoint was therefore not evaluated in the definitive test. - Results with reference substance (positive control):
- EC50 value for the reference item was 102 mg/L (95% CI: 98.4-106 mg/L). This is in the recommended range of validity of 53-155 mg/L.
- Reported statistics and error estimates:
- The NOEC was determined by calculation of statistical significance of the inhibition of respiration in comparison to the control. One Way Analysis of Variance (ANOVA) was used for NOEC calculation.When running a One Way Analysis of Variance a Normality test and an Equal Variance test were done first. P-value for both tests was 0.05. The a-value (acceptable probability of incorrectly concluding that there is a difference) is a=0.05.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the 3h-NOEC of the test substance is > 1000 mg/L. The test substance caused no inhibiting effects on activated sludge of a municipal sewage treatment plant at the limit test item concentration of 1000 mg/L.
- Executive summary:
The effect of test item on the respiration rate of activated sludge was assessed according to OECD Guideline 209 with GLP statement.
The test system was activated sludge of the municipal treatment plant of 31137 Hildesheim, Germany. The test was carried out under static conditions with the limit test item concentration 1000 mg/L. The respiration rates of the control, reference and test item replicates were measured after a contact time of three hours, and the inhibitory effects of the test and reference item were determined in comparison to the control respiration rates.
The mean inhibition of respiration for the test item replicates was 4% at 1000 mg/L.
In order to check the activity of the test system and the test conditions a reference test was carried out with copper (II) sulphate pentahydrate as reference item and the reference toxicity was determined. The EC50-value for the reference item was 102 mg/L.
Under the test conditions, the 3h-NOEC of the test substance is > 1000 mg/L. The test substance caused no inhibiting effects on activated sludge of a municipal sewage treatment plant at the limit test item concentration of 1000 mg/L.
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[further information is included as attachment to Iuclid section 13]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the structural similarity between the source and the target substances (stereoisomers) and comparable properties related to the target endpoints.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Refer to the Test material section of the source and target records.
3. ANALOGUE APPROACH JUSTIFICATION
See attached document in Iuclid section 13
4. DATA MATRIX
See attached document in Iuclid section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Remarks:
- Read-Across justification document
- Key result
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- According to the experimental study performed on the source substance, the 3h-NOEC of the target substance is determined to be greater than 1000 mg/L.
- Executive summary:
No experimental study is available on the target substance to assess the toxicity of the registered substance to microorganisms. Therefore, good quality data for a related source substance have been read-across for this endpoint. The structural similarity and available data between the source and the target substances support the read-across hypothesis. Adequate, reliable and available scientific information indicates that the source and target substances have similar ecotoxicological profile. The Read-Across justification document is provided in section 13 of IUCLID.
The Activated Sludge Respiration Inhibition test (ASRIT), performed on the source substance, was conducted according to OECD Test Guideline 209 with GLP statement. The test system was activated sludge of the municipal treatment plant of 31137 Hildesheim, Germany. The test was carried out under static conditions with the limit test item concentration 1000 mg/L. The respiration rates of the control, reference and test item replicates were measured after a contact time of three hours, and the inhibitory effects of the test and reference item were determined in comparison to the control respiration rates. The mean inhibition of respiration for the test item replicates was 4% at 1000 mg/L. In order to check the activity of the test system and the test conditions a reference test was carried out with copper (II) sulphate pentahydrate as reference item and the reference toxicity was determined. The EC50-value for the reference item was 102 mg/L. Under the test conditions, the 3h-NOEC of the test substance is > 1000 mg/L. The test substance caused no inhibiting effects on activated sludge of a municipal sewage treatment plant at the limit test item concentration of 1000 mg/L.
Therefore, based on the considerations above, it can be concluded that the result of the ASRIT study conducted with the source substance is likely to predict the properties of the target substance and is considered as adequate to fulfil the information requirement of Annex VIII, 9.1.4 of the REACH regulation.
Referenceopen allclose all
Table 6.1.7/3: Inhibitions in the Preliminary test
Nominal test item concentration (mg/L)
|
pH (test item in demin. water) |
pH (adjusted to) |
pH (test item in medium) |
Inhibition (%) |
Preliminary test – without pH adjustment, direct aeration |
||||
10 |
- |
- |
- |
1 |
- |
- |
- |
-1 |
|
100 |
- |
- |
- |
6 |
- |
- |
- |
-1 |
|
1000 |
- |
- |
7.57 |
4 |
- |
- |
- |
3 |
Table 6.1.7/4: Inhibition of the Nitrification in the Preliminary test (with / without ATU)
Nominal test item concentration (mg/L) |
Inhibition of total respiration (%) |
Inhibition of heterotrophic respiration + ATU* (%) |
Inhibition of nitrification (%) |
1000 |
4 |
19 |
-8 |
3 |
7 |
-2 |
* ATU = N-Allylthiourea
Table 6.1.7/5: Oxygen uptake rates and inhibition of the respiration of the control and test item concentrations
Test and reference item concentration (mg/L) |
Repl. |
Oxygen uptake rate (mg O2/L.h) |
Inhibition (%) |
Mean inhibition (%) |
Control |
1 2 3 4 5 6 |
24.4 24.0 24.0 22.4 22.8 22.8 |
- |
- |
Test item 1000 |
1 2 3 |
22.4 22.4 22.4 |
4 4 4 |
4 |
Reference item 58 |
1 2 3 |
17.6 18.0 18.0 |
25 23 23 |
24 |
Reference item 100 |
1 2 3 |
12.4 12.8 12.4 |
47 45 47 |
46 |
Reference item 180 |
1 2 3 |
4.8 4.8 4.8 |
79 79 79 |
79 |
Repl. = replicate
Coefficient of variation of oxygen uptake rates of the control: 3.5%
Suspended solids in the test vessel: 1.36 g/L
Table 6.1.7/6: Specific respiration rates of the control replicates
Control |
Replicates |
Specific respiration rate Rs(mg O2/g.h) |
1 |
17.9 |
|
2 |
17.6 |
|
3 |
17.6 |
|
4 |
16.5 |
|
5 |
16.8 |
|
6 |
16.8 |
|
Mean value |
17.2 |
Repl. = replicate
Suspended solids in the test vessel: 1.36 g/L
Validity criteria:
- The mean specific oxygen uptake rate of the control replicates was 17.2 mg O2/g.h and therefore not meeting the criterion (validity criterion: should be ≥ 20 mg 02/g.h). The oxygen uptake of activated sludge from municipal treatment plants is influenced by seasonal fluctuations and fluctuations in sewage flow etc. The lower oxygen uptake rate reflects the range of common uptake rates of activated sludge from municipal treatment plants and was considered to have no impact on quality and integrity of the study. Despite the lower respiration, the EC50-value of the reference item was in the required range. Therefore, no impact on the results of the test item can be expected through lower respiration.
- The coefficient of variation of the oxygen uptake rates in the control replicates was 3.5 % (validity criterion: < 30 %).
- The EC50 of the reference item was in the range of 53 - 155 mg/L.
Description of key information
Read-across, OECD Guideline 209, GLP, key study, validity 1:
3h-NOEC > 1000 mg/L
Key value for chemical safety assessment
Additional information
To assess the toxicity of the registered (target) substance to microorganisms, one experimental study is available on a source substance, Reaction Mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]-3-hexanol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]-3-hexanol (EC 947-716-8). The structural similarity and available data between the source and the target substances support the read-across hypothesis. Adequate, reliable and available scientific information indicates that the source and target substances have similar ecotoxicological profile. The Read-Across justification document is provided in section 13 of IUCLID.
This valid study was performed according to OECD Guideline 209 (ASRIT) in compliance with GLP on the source substance. To assess the effect of the substance on the respiration rate of activated sludge, the test was carried out under static conditions with the limit test item concentrations 1000 mg/L. The respiration rates of the control, reference and test item replicates were measured after a contact time of three hours, and the inhibitory effects of the test and reference item (copper (II) sulphate pentahydrate) were determined in comparison to the control respiration rates. The mean inhibition of respiration for the test item replicates was 4% at 1000 mg/L. The EC50-value for the reference item was 102 mg/L. Under the test conditions, the 3h-NOEC of the test substance is > 1000 mg/L. The test substance caused no inhibiting effects on activated sludge of a municipal sewage treatment plant at the limit test item concentration of 1000 mg/L.
Based on the considerations above, it can be concluded that the result of the ASRIT study conducted with the source substance is likely to predict the properties of the target substance and is considered as adequate to fulfil the information requirement of Annex VIII, 9.1.4 of the REACH regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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