Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-415-5 | 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:
- 30 May 2013 - 28 August 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Amounts of test item (5, 50 and 500 mg (in triplicate)) were each separately dispersed in approximately 200 mL of deionized reverse osmosis water and subjected to ultrasonication for approximately 15 minutes followed by magnetic stirring for 24 hours in order to maximize the dissolved test item concentration. All test vessels were shielded from the light during mixing. Synthetic sewage (16 mL), activated sewage sludge (250 mL) and water were added to a final volume of 500 mL to give the required concentrations of 10, 100 and 1000 mg/L (3 replicates). The pH of the test item dispersions was measured after stirring using a WTW pH/Oxi 3401 pH and dissolved oxygen meter and adjusted to between pH 7.0 and 8.0 if necessary.
- Controls: The control group was maintained under identical conditions but not exposed to the test item.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): oily film visible on surface - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Laboratory culture: A mixed population of activated sewage sludge micro-organisms was obtained on 30 May 2013 from the aeration stage of the Severn Trent Water Pic sewage treatment plant at Loughborough, Leicestershire, UK which treats predominantly domestic sewage.
- Preparation of inoculum for exposure: The activated sewage sludge sample was maintained on continuous aeration in the laboratory at a temperature of approximately 21 deg C overnight prior to use in the test. On the day of collection the activated sewage sludge (10 liters) was allowed to settle and 2 liters of the supernatant was removed to increase the suspended solids concentration. The remaining 8 liters was fed synthetic sewage sludge (400 mL). The pH of the sample on the day of the test was 7.2 measured using a WTW pH/Oxi 3401 pH and dissolved oxygen meter.
The initial suspended solids concentration before removal of the supernatent was equal to 2.5 g/L. After removal of the supernatant and aeration overnight, the suspended solids concentration was repeated and was equal to 4.2 g/L. The activated sewage sludge sample was diluted with dechlorinated tap water (3 liters) and the suspended solids concentration was repeated and was equal to 3.0 g/L prior to use. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Test temperature:
- 20 +/- 2 deg C
- pH:
- 7.0-7.3
- Dissolved oxygen:
- 2.8-5.8 mg O2/L
- Nominal and measured concentrations:
- Nominal: 10, 100, 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Conical flask
- Material, size, headspace, fill volume: glass, 500 mL
- Aeration: yes, 0.5-1.0 L/min
- No. of vessels per concentration (replicates): 1 for 10 & 100 mg/L and 3 for 1000 mg/L
- No. of vessels per control (replicates):
- Biomass loading rate:
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
OTHER TEST CONDITIONS
- Light intensity: normal laboratory lighting
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Respiration rate
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10x
- Range finding study
- Test concentrations: 0, 10, 100 or 1000 mg/L
- Results used to determine the conditions for the definitive study: Definitve study was not conducted based on the results of the range-finding study - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- 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:
- - Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: oily film seen on surface during test
- Effect concentrations exceeding solubility of substance in test medium: yes - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: 3-h EC50 = 6.0 mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of the test item on the respiration of activated sewage sludge micro-organisms gave a 3-Hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L.
- Executive summary:
Introduction
A study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2010) No. 209 "Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)".
Methods
Activated sewage sludge was exposed to an aqueous dispersion of the test item at concentrations of 10, 100 and 1000 mg/L (3 replicates of the 1000 mg/L test concentration) for a period of 3 hours at a temperature of 20 ± 2 deg. C with the addition of a synthetic sewage as a respiratory substrate. The rate of respiration was determined after 3 hours contact time and compared to data for the control and a reference item, 3,5-dichlorophenol.
Results
The effect of the test item on the respiration of activated sewage sludge gave a 3-Hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L. The reference item gave a 3-Hour EC50 value of 6.0 mg/L, 95% confidence limits 4.6-7.9 mg/L.
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1999/02/25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Version / remarks:
- (1984)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.6800 (Modified Activated Sludge, Respiration Inhibition Test for Sparingly Soluble Chemicals)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Commission Directive 87/302/EEC
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, date of inspection 23 March 1998
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
The justification for read-across is presented in Section 13 Assessment reports- Read-across justification. - Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An amount of test substance (500 mg) was dispersed in approx. 250 mL of water and subjected to ultrasonication for approx. 30 min. Synthetic sewage (16 mL), activated sewage sludge (200 mL) and dechlorinated tap water were added to a final volume of 500 mL to give the test concentration of 1000 mg/L.
- Controls: same conditions but without addition of test substance - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Source of inoculum: A mixed population of activated sewage sludge micro-organisms was obtained on 25. February 1999 from the aeration stage of the Severn Trent Water Plc sewage treatment plant at Belper, Derbyshire, UK.
- Method of cultivation: The sample was maintained on continuous aeration in the laboratory at a temperature of 21 °C and was used on the day of collection. The pH of the sample was 7.5. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Test temperature:
- 21 °C
- Nominal and measured concentrations:
- Nominal concentrations: control - 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 500 mL conical flask
- Aeration: aerated with compressed air at a rate of approx. 0.5-1 L/min
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water dechlorinated by passage through an activated carbon filter
EFFECT PARAMETERS MEASURED: respiration rate after 30 min and 3 h
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: control - 100 - 1000 mg/L
- Results used to determine the conditions for the definitive study: No significant effect on respiration was observed at all the test concentrations employed. - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
- Duration:
- 30 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- 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
- Remarks:
- respiration rate
- Details on results:
- - Effect concentrations exceeding solubility of substance in test medium: The effect concentrations exceeded the water solubility of the test substance.
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: EC50 (30 min): 15 mg/L; EC50 (3 h): 8.0 mg/L - Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 14 April 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- GLP compliance:
- yes
- Remarks:
- Steinbeis-Transferzentrum, Angewandte und Umwelt-Chemie an der Fachhochschule Reutlingen, Reutlingen, Germany
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
The justification for read-across is presented in Section 13 Assessment reports- Read-across justification. - Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test substanz was emulsified using Ultra-Turrax. - Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- - Laboratory culture: Activated sludge from sewage plant Bempflingen, Germany
- Preparation of inoculum for exposure: Activated sludge was washed with tap water twice, afterwards centrifuged and the dry residue was
determined. The amount of the sludge was weighed per liter, which was corresponded to 4 g dry mass. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Test temperature:
- 20 ± 2°C
- Dissolved oxygen:
- > 6.5 mg/l
- Nominal and measured concentrations:
- Nominal: 10000 mg/l
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 500 ml fill volume
- Aeration: Continously to reach an oxygen content > 6.5 mg/l
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Unchlorinated tap water
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Respiration inhibition by decrease of oxygen content, measured with a
xt-Schreiber in 15-minutes-pulses. - Reference substance (positive control):
- yes
- Remarks:
- 3,5 dichlorphenol
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Duration:
- 3 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Results with reference substance (positive control):
- - Relevant effect levels: EC50 = 5 mg/l is in the range 5 to 30 mg/l
- Endpoint:
- toxicity to microorganisms
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 07 February 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Cell multiplication inhibition test according to Bringman and Kuehn (1980), Water Research 14
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
The justification for read-across is presented in Section 13 Assessment reports- Read-across justification. - Analytical monitoring:
- no
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A 10 mg/l (nominal concentration) of the test substance in acetone was prepared and used for the test.
- Chemical name of vehicle: Acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 0.1% v/v (final concentration in the system) - Test organisms (species):
- Pseudomonas putida
- Details on inoculum:
- - Laboratory culture: Pseudomonas putida, strain NCIMB9494, obtained as a freeze-dried culture from National Collections of Industrial and Marine
Bacteria Ltd, Aberdeen, UK
- Method of cultivation: The freeze-dried culture was rehydrated in 0.5 ml of nutrient broth (Oxoid Ltd). A loop of this suspension was streaked onto a nutrient agar (Oxoid Ltd) slope in a universal bottle. This was incubated at 25°C for 24 hours, and then stored at laboratory temperature, until use
as stock culture.
- Preparation of inoculum for exposure: 18-20 hours before the start of the test 4 ml of test medium concentrate were added to 46 ml of deionised
water in a sterile conical flask. A loop of Pseudomonas putida stock culture was added to this growth medium solution, and then incubated overnight at 25°C on an orbital shaker (150 rpm).
- Pretreatment: After incubation the cells were diluted by addition of fresh growth medium solution at 25°C to an optical density which gave an
absorbance of 0.8 (± 0.05) at 600 nm (4 cm cells). This was used as the test inoculum. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 6 h
- Nominal and measured concentrations:
- Nominal: 10 mg/l
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Concial flasks contained 50 ml volume
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 3
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Basalt salt solution was prepared dissolved in 1 Litre of deionised water. This solution was autoclaved at 121°C for 15 minutes. A glucose solution was prepared containing 6.25 g of glucose dissolved in 1 Litre of deionised water. This solution was autoclaved at 121°C for 15 minutes. Equal volumes of the salt solution and the glucose solution were mixed together with a sterile flask to form a growth mediumconcentrate.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Growth inhibition after 6 hours by measurements of the optical density of
each flask content at 600 nm - Reference substance (positive control):
- yes
- Remarks:
- 3,5 dichlorophenol
- Duration:
- 6 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Duration:
- 6 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Details on results:
- - Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test material did not completely
dissolve in the test system. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: 96% inhibition of growth at 18 mg/L solution of 3,5 dichlorophenol - Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: analogue substance
- Justification for type of information:
- Toxicity to microorganisms does not need to be investigated because available data indicate that structural variation does not influence test results or adverse effect profile (see read-across and category justifications attached in Section 13).
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
Referenceopen allclose all
The dissolved oxygen concentrations after 30 minutes contact time in several of the vessels were below 60% of the dissolved oxygen saturation level of 8.9 mg O2/L. This deviation to the study plan was considered to have had no adverse effect on the study given that all oxygen consumption values were measured/calculated over the linear portion of the traces.
No statistically significant toxic effects were shown at all of the test concentrations employed. It was therefore considered justifiable not to perform a definitive test.
It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L.
The validation criteria for the control respiration rates and reference material EC50 values have been satisfied. The test resulted in an EC50 (3 h) of greater than 1000 mg/L.
Table 1: Oxygen consumption rates and percentage inhibition values in the definitive study after 3 h contact time
(RS = Reference substance; - = increase in respiration rate as compared to controls)
Nominal concentration [mg/L] |
Initial O2 reading [mg O2/L] |
Measurement period [min] |
Final O2 reading [mg O2/L] |
O2 Consumption rates [mg O2/L/min] |
% Inhibition |
Control R1 |
6.5 |
10 |
1.4 |
0.51 |
- |
Control R2 |
6.4 |
10 |
1.4 |
0.50 |
- |
1000 R1 |
6.1 |
10 |
1.2 |
0.49 |
3 |
1000 R2 |
7.2 |
10 |
2.8 |
0.44 |
13 |
1000 R3 |
6.5 |
10 |
1.4 |
0.51 |
-1 |
RS R1 |
6.4 |
10 |
1.8 |
0.46 |
9 |
RS R2 |
7.7 |
10 |
6.1 |
0.16 |
68 |
RS R3 |
8.0 |
10 |
7.2 |
0.08 |
84 |
An increase about 43% of respiration rate could be observed at the nominal tested concentration of 10000 mg/l in comparison to the control. The EC50 (3h) was determined as > 10000 mg/l.
Table 1: Respiration rate of control, reference and test substance and inhibition of the respiration rate of test and reference substance (*A negative sign means an increase of the respiration)
|
|
Concentration [mg/l] |
Respiration rate [mg O2/L x h] |
Inhibition [%] |
Control |
K1 |
|
24.0 |
- |
Referenz |
R1 |
2.5 10 30 |
22.0 11.0 5.0 |
10.2 55.1 79.6 |
Test substance |
T1 |
10000 |
35.0 |
-43.0* |
The nominal 10 mg/l solution of the test substance gave no inhibition of growth. The EC10 and EC50 (6h) for the test substance to Pseudomonas putida was > 10 mg/l (nominal) test material.
Table 1: Optical density results
Flasknumber |
Contents |
Mean of optical density at 600 nm (4 cm cells) |
Minus value for uninoculated solution |
% inhibition |
1-3 |
Control |
0.602 |
0.569 |
|
4-6 |
18 mg/l 3,5 dichlorophenol |
0.025 |
|
96 |
7-9 |
0.1% Acetone |
0.589 |
0.579 |
|
13-15 |
10 mg/l PentaerythritolC7-C10 tetra ester |
0.630 |
0.614 |
- |
16 |
Blank uninoculated |
0.033 |
|
|
17 |
0.1% Acetone uninoculated |
0.010 |
|
|
19 |
10 mg/l PentaerythritolC7-C10 tetra ester uninoculated |
0.016 |
|
|
Description of key information
One reliable study is available. In this study activated sewage sludge was exposed to aqueous dispersions of an analogue substance (EC 613 -848 -7) at up to 1000 mg/L with the addition of synthetic sewage as a respiratory substrate for 3 hours. Based on the rate of respiration, the EC50 (3 h) was > 1000 mg/L and the NOEC (3 h) was 1000 mg/L. The substance is not harmful to microorganisms.
Key value for chemical safety assessment
Additional information
One reliable study is available. In this study (Roulstone, 2013) performed under GLP according to OECD TG 209, activated sewage sludge was exposed to an aqueous dispersion of the analogue test item at concentrations of 10, 100 and 1000 mg/L (3 replicates of the 1000 mg/L test concentration) for a period of 3 hours at a temperature of 20 ± 2 deg. C with the addition of a synthetic sewage as a respiratory substrate. The rate of respiration was determined after 3 hours contact time and compared to data for the control and a reference item, 3,5-dichlorophenol. The 3-Hour EC50 value was > 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L.
The results of this study are supported by data available for the read across substances fatty acid polyols (Fatty acids, C5-9, esters with pentaerythritol (EC 270-290-3, CAS 68424-30-6) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234-392-1, CAS 11138-60-6)) and their analogues is applicable based on the similarity in structure and physico-chemical properties. The substances with the CAS No. 131459-39-7 and EC 270 -290 -3 are structural analogues of one of the read-across substances (CAS No. 68424-30-6) and can therefore can also be used for read-across to EC 613 -848 -7.
The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.
One study, investigating the toxicity to microorganisms, was available for Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234 -392 -1, CAS-No. 11138-60-6). This respiration inhibition test (Kuttler, 1998) with activated sludge (domestic) according to OECD 209 showed an increase about 43% of respiration rate at the nominal tested concentration of 10000 mg/L in comparison to the control. No inhibition of respiration rate was observed. Therefore the EC50 and EC10 (3h) can be stated as > 10000 mg/L (nominal).
In a static GLP-study conducted to OECD 209 (Mead, 1999) 3,5,5-trimethylhexanoic acid mixed tetraesters with PE and valeric acid (CAS-No. 131459-39-7), was mixed with activated sludge of predominantly domestic sewage. No effect on respiration rate was observed at the tested concentration (EC50 (3h) > 1000 mg/L, NOEC (3h) ≥ 1000 mg/L). Due to the low water solubility of the test substance, no toxicity was observed within the water solubility under the conditions tested.
In addition, in a third study (Comber and Coleman), a cell multiplication inhibition test with Pseudomonas putida according to Bringman and Kuehn (1980) for Fatty acids, C5-10, esters with pentaerythritol (EC 270 -290 -3, CAS-No. 68424-31-7), no inhibition on the growth was observed at the tested concentration (EC10 and EC50 (6h) > 10 mg/L (nominal)). As the test material in this study not completely dissolved in the test system, the tested concentration demonstrated the worst case.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.