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EC number: 701-338-8 | 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:
- toxicity to microorganisms, other
- Remarks:
- Pseudomonas putida growth inhibition test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6-9-1996 to 7-9-1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study done under an accepted guideline and GLP, by read-across on an analogue substance. The study is valid and compliant to the guideline. However data is missing on phys/chem properties of the test substance (like solubility and stability) and therefore the actual exposure is uncertain, this is the main restriction.
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10712
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring Authority, Dep. Helth UK, 1996
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): dimethylsulphoxide
- Method: For the purpose of the definitive study the test material was prepared using a preliminary slurry in dimethylsulphoxide. An amount of test material (20 mg) was mixed with 200 uL of dimethylsulphoxide and 15 mL sterile reverse osmosis water to form a slurry prior to dispersal in sterile reverse osmosis water with the aid of ultrasonic disruption.
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s) The volume was then adjusted to 2 L to give a 10 mg/L stock solution. To an aliquot (80 mL) of the 10 mg/L stock solution, nutrient stock solutions and bacterial suspension were added to give the required test concentration of 8.0 mg/L. - Test organisms (species):
- Pseudomonas putida
- Details on inoculum:
- - Strain: Pseudomonas putida strain NCIB 8248
- Laboratory culture: Freeze dried cultures of Pseudomonas putida were obtained from the National Collection of Industrial Bacteria, Aberdeen, Scotland
- Method of cultivation: maintained in the laboratory by routine sub-culturing onto fresh agar slopes, approximately once per week. The cultures were maintained in the laboratory at a temperature of 25 C.
- Preparation of inoculum for exposure: Approximately 17 hours prior to commencing the test, an aqueous suspension of Pseudomonas putida was produced by adding pre-culture medium to a stock culture of the bacterium and gently shaking in order to wash the bacterial cells off the solid medium. The resultant suspension was dispersed into a sterile flask plugged with sterile non-absorbent cotton wool and incubated at 25· C. After the initial incubation period of approximately 17 hours, the bacterial suspension was diluted using pre-culture medium to give a turbidity of approximately 100 Formazine Turbidity Units (FTU) An aliquot (50 mL) of the 100 FTU bacterial suspension was added to 450 mL of pre-culture medium and incubated at 25 C.
After incubation at 25 C for 6 hours the bacterial suspension had a turbidity of approximately 50 FTU. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 16 h
- Test temperature:
- 25 °C
- Nominal and measured concentrations:
- Range-finding study: nominal: 0.8 and 8.0 mg/L
Definitive study: 8.0 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mlL glass conical flasks
- Type (delete if not applicable): closed
- Fill volume: 100 mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 10
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): bacterial growth by measurement of the absorbance at 436 nm
TEST CONCENTRATIONS
- Range finding study: 0.8 and 8 mg/L
- Test concentrations: 6 mg/L
- Results used to determine the conditions for the definitive study: no effect on bacterial growth - Reference substance (positive control):
- no
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Details on results:
- Statistical analysis of the absorbance values was carried out for the solvent control and 8.0 mg/L test group using a Students t-test. There were no statistically significant differences (P ~0.05), between the solvent control and 8.0 mg/L test group and therefore the "No Observed Effect Concentration" (NOEC) is given as ~ 8.0 mg/L
The test concentration of 8.0 mg/L was the highest attainable test concentration that could be prepared due to the limited solubility of the test material in water and auxiliary solvent and the limitations imposed for the addition of nutrient solutions and bacterial suspension to the test material stock solution. Other recognised auxiliary solvents were used during the preliminary solubility work performed, however, dimethylsulphoxide was found to give the best testable dispersion of the test material in water. - Reported statistics and error estimates:
- A Students t-test was carried out on the absorbance values after 16 hours exposure for the solvent control and 8.0 mg/L test concentration to determine any statistically significant differences between the test and solvent control groups.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of on the growth of Pseudomonas putida has been investigated and gave EClO and ECso values of greater than 8.0 mg/l. The EClO value of greater than 8.0 mg/L corresponds to an evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme of less than 5.1. The study is valid and compliant to the guideline. However data is missing on phys/chem properties of the test substance (like solubility and stability) and therefore the actual exposure is uncertain.
- Executive summary:
Methods
A study was performed to assess the effect of the test material on the growth of the bacteriaPseudomonas putida. The method followed that described in the German Water Hazard Classification Scheme (Bewertung Wassergefahrdender Stoffe LTWS - Nr 10) and ISO 10712 "Determination of the inhibitory effect of water constituents on bacteria (Pseudomonascell multiplication inhibition test)".
Procedure:
Following a preliminary range-finding study,Pseudomonas putidawas exposed to an aqueous dispersion of the test material at a concentration of 8.0 mg/L (six replicate flasks) for approximately 16 hours at a temperature of 25 C. Samples of the bacterial populations were removed after approximately 16 hours and absorbance values determined for each control and treatment group.
Results
Exposure ofPseudomonas putidato the test material gave an EC10 and an EC50 values of greater than 8.0 mg/l. The EC10 value of greater than 8.0 mg/I corresponds to an evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme of less than 5.1. The test concentration of 8.0 mg/L was the highest attainable test concentration that could be prepared due to the limited solubility of the test material in water and auxiliary solvent and the limitations imposed by the addition of nutrient solutions and bacterial suspension to the test material stock solution.
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- Pseudomonas putida growth inhibition test
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 6-9-1996 to 7-9-1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study done under an accepted guideline and GLP, by read-across based on a chemical category. The study is valid and compliant to the guideline. However data is missing on phys/chem properties of the test substance (like solubility and stability) and therefore the actual exposure is uncertain, this is the main restriction.
- Justification for type of information:
- This study was conducted on 2,5-furandione, dihydro-, mono-C15- 20-alkenyl derivatives (CAS 68784-12-3), an analogue substance used as the source of information for the assessment of the target substance through read-across. Therefore, this study is informative for evaluation of the environmental fate and toxicity of the target substance, Reaction products of furan-2,5-dione and octadec-1-ene (known here as n-ODSA EC 701-338-8; no CASRN available), and it is adequate for classification and risk assessment.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10712
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring Authority, Dep. Helth UK, 1996
- Specific details on test material used for the study:
- As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): dimethylsulphoxide
- Method: For the purpose of the definitive study the test material was prepared using a preliminary slurry in dimethylsulphoxide. An amount of test material (20 mg) was mixed with 200 uL of dimethylsulphoxide and 15 mL sterile reverse osmosis water to form a slurry prior to dispersal in sterile reverse osmosis water with the aid of ultrasonic disruption.
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s) The volume was then adjusted to 2 L to give a 10 mg/L stock solution. To an aliquot (80 mL) of the 10 mg/L stock solution, nutrient stock solutions and bacterial suspension were added to give the required test concentration of 8.0 mg/L. - Test organisms (species):
- Pseudomonas putida
- Details on inoculum:
- - Strain: Pseudomonas putida strain NCIB 8248
- Laboratory culture: Freeze dried cultures of Pseudomonas putida were obtained from the National Collection of Industrial Bacteria, Aberdeen, Scotland
- Method of cultivation: maintained in the laboratory by routine sub-culturing onto fresh agar slopes, approximately once per week. The cultures were maintained in the laboratory at a temperature of 25 C.
- Preparation of inoculum for exposure: Approximately 17 hours prior to commencing the test, an aqueous suspension of Pseudomonas putida was produced by adding pre-culture medium to a stock culture of the bacterium and gently shaking in order to wash the bacterial cells off the solid medium. The resultant suspension was dispersed into a sterile flask plugged with sterile non-absorbent cotton wool and incubated at 25· C. After the initial incubation period of approximately 17 hours, the bacterial suspension was diluted using pre-culture medium to give a turbidity of approximately 100 Formazine Turbidity Units (FTU) An aliquot (50 mL) of the 100 FTU bacterial suspension was added to 450 mL of pre-culture medium and incubated at 25 C.
After incubation at 25 C for 6 hours the bacterial suspension had a turbidity of approximately 50 FTU. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 16 h
- Test temperature:
- 25 °C
- Nominal and measured concentrations:
- Range-finding study: nominal: 0.8 and 8.0 mg/L
Definitive study: 8.0 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mlL glass conical flasks
- Type (delete if not applicable): closed
- Fill volume: 100 mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 10
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): bacterial growth by measurement of the absorbance at 436 nm
TEST CONCENTRATIONS
- Range finding study: 0.8 and 8 mg/L
- Test concentrations: 6 mg/L
- Results used to determine the conditions for the definitive study: no effect on bacterial growth - Reference substance (positive control):
- no
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Details on results:
- Statistical analysis of the absorbance values was carried out for the solvent control and 8.0 mg/L test group using a Students t-test. There were no statistically significant differences (P ~0.05), between the solvent control and 8.0 mg/L test group and therefore the "No Observed Effect Concentration" (NOEC) is given as ~ 8.0 mg/L
The test concentration of 8.0 mg/L was the highest attainable test concentration that could be prepared due to the limited solubility of the test material in water and auxiliary solvent and the limitations imposed for the addition of nutrient solutions and bacterial suspension to the test material stock solution. Other recognised auxiliary solvents were used during the preliminary solubility work performed, however, dimethylsulphoxide was found to give the best testable dispersion of the test material in water. - Reported statistics and error estimates:
- A Students t-test was carried out on the absorbance values after 16 hours exposure for the solvent control and 8.0 mg/L test concentration to determine any statistically significant differences between the test and solvent control groups.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The effect of on the growth of Pseudomonas putida has been investigated and gave EClO and ECso values of greater than 8.0 mg/l. The EClO value of greater than 8.0 mg/L corresponds to an evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme of less than 5.1. The study is valid and compliant to the guideline. However data is missing on phys/chem properties of the test substance (like solubility and stability) and therefore the actual exposure is uncertain.
- Executive summary:
Methods
A study was performed to assess the effect of the test material on the growth of the bacteriaPseudomonas putida. The method followed that described in the German Water Hazard Classification Scheme (Bewertung Wassergefahrdender Stoffe LTWS - Nr 10) and ISO 10712 "Determination of the inhibitory effect of water constituents on bacteria (Pseudomonascell multiplication inhibition test)".
Procedure:
Following a preliminary range-finding study,Pseudomonas putidawas exposed to an aqueous dispersion of the test material at a concentration of 8.0 mg/L (six replicate flasks) for approximately 16 hours at a temperature of 25 C. Samples of the bacterial populations were removed after approximately 16 hours and absorbance values determined for each control and treatment group.
Results
Exposure ofPseudomonas putidato the test material gave an EC10 and an EC50 values of greater than 8.0 mg/l. The EC10 value of greater than 8.0 mg/I corresponds to an evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme of less than 5.1. The test concentration of 8.0 mg/L was the highest attainable test concentration that could be prepared due to the limited solubility of the test material in water and auxiliary solvent and the limitations imposed by the addition of nutrient solutions and bacterial suspension to the test material stock solution.
Referenceopen allclose all
Description of key information
The key study was an acute bacterial toxicity test (Pseudomonas putida cell multiplication inhibition test) by read-across from an analogue substance, conducted in accordance with an established guideline.
Key value for chemical safety assessment
- EC50 for microorganisms:
- 8 mg/L
- EC10 or NOEC for microorganisms:
- 8 mg/L
Additional information
The inhibition of cell multiplication of Pseudomonas putida, by read-across from an analogue substance, was determined in a limit test from the key study. The 16-h NOEC was reported as ≥ 8.0 mg/L; the 16-h EC10 and 16-h EC50 were each reported as > 8.0 mg/L.
This information is from the substance 2,5-furandione, dihydro-,mono-C15-20-alkenylderivatives (CAS 68784-12-3, a mixture of a hexadecenyl- and octadecenyl succinic anhydrides, and also known as PentasizeTM68, AS 1100TMand AS 1000TM), an analogue used for the assessment of several endpoints through read-across. The hypothesis for read-across between the substance being registered (Reaction products of furan-2,5-dione and octadec-1-ene; known here as n-ODSA EC 701-338-8; no CASRN available), and the analogue substance is a common functional group: a 2,5-furandione, dihydro- structure, also known as a succinic anhydride, to which is attached a long-chain monounsaturated olefin. In the environment, the anhydride moiety is quickly hydrolysed to form a dioic acid. When the substance to be registered and the analogue substance are compared, changes in the purity of the starting olefin stock, or small differences in the length (between sixteen and twenty) or arrangement (linear or branched) of the carbon chain are not anticipated to significantly affect the environmental fate properties or the toxicity of the substances. For each endpoint study based upon read-across, the analogue approach is substantiated by an evaluation provided in the Analogue Approach Report Format (AARF) attached to the endpoint study summary file. The AARF allows the read-across information to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.
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.