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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 285-203-4 | CAS number: 85049-34-9
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Feb - 23 Mai 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 6.25, 12.5, 25, 50, 100 mg/L (Only the undiluted filtrate of stock suspension was analysed.)
- Sampling method: Duplicate samples were taken from all test concentrations and the control on day 0, 7 and 16. On days 2, 9 and 19 a sufficient volume from the old test media of all test concentrations and the control were sampled for the determination of the stability of the test item. One of these three stability control treatments last for 72 h (weekend), two for 48 h, corresponding to the different test medium renewal periods.
- Sample storage conditions before analysis: Samples were analysed directly. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: For each treatment a concentrated stock suspension of the test item of nominal 100 mg/L was prepared by suspending 200 and 500 mg test item into 2 and 5 L test water, respectively. The suspensions were ultrasonically treated for 15 min and stirred between 48 and 73 h. Stock suspensions were filtered through a cellulose nitrate filter (pore size 0.45 µm). Adequate amounts of stock solution were diluted with test water to prepare the test media of the lower test concentrations.
- Eluate: no
- Differential loading: no
- Controls: yes, test water control - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: Originally supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany.
- Feeding during test
- Food type: Green algae (Scenedesmus subspicatus)
- Amount: Based on the total organic carbon (TOC) in the algal food suspension. 0.1 mg TOC/Daphnia (day 0,1), 0.15 mg TOC/Daphnia (day 5-8, 12-13), 0.2 mg TOC/Daphnia (day 2, 14-15, 19-20), 0.3 mg TOC/Daphnia (day 9), 0.4 mg TOC/Daphnia (day 16)
- Frequency: every day
ACCLIMATION
- Acclimation conditions: same as test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Test temperature:
- 21 °C
- pH:
- 7.8 - 8.5
- Dissolved oxygen:
- 7.7 - 8.9 mg/L
- Nominal and measured concentrations:
- nominal: 0, 6.25, 12.5, 25, 50, 100 mg/L
measured: 0.04 – 0.06 mg/L (day 0), 0.023 – 0.030 mg/L (day 7), 0.025 – 0.035 mg/L (day 16) - Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, 100 mL, headspace: 20 mL, fill volume: 80 mL
- Renewal rate of test solution (frequency/flow rate): renewed on day 2, 5, 7, 9, 12, 14, 16, 19
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to OECD guideline 211
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 400 - 420 lux
EFFECT PARAMETERS MEASURED: Mortality of adults and number of young daphnids was recorded every day. Offspring were removed at the same time.
RANGE-FINDING STUDY
- Other: A range-finding study was performed to determine the test concentrations for the definitive study. Results were not reported. - Reference substance (positive control):
- no
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality
- Details on results:
- - Mortality of parent animals: 0%
- Time to first brood release or time to hatch: between day 8 and 9 - Validity criteria fulfilled:
- yes
- Conclusions:
- After 21 days the NOELR was determined to be >= 0.02 mg/L and the EL50 was determined to be > 50 mg/L.
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 21 Feb - 23 Mai 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Justification for type of information:
- Please refer section 13 for read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 6.25, 12.5, 25, 50, 100 mg/L (Only the undiluted filtrate of stock suspension was analysed.)
- Sampling method: Duplicate samples were taken from all test concentrations and the control on day 0, 7 and 16. On days 2, 9 and 19 a sufficient volume from the old test media of all test concentrations and the control were sampled for the determination of the stability of the test item. One of these three stability control treatments last for 72 h (weekend), two for 48 h, corresponding to the different test medium renewal periods.
- Sample storage conditions before analysis: Samples were analysed directly. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: For each treatment a concentrated stock suspension of the test item of nominal 100 mg/L was prepared by suspending 200 and 500 mg test item into 2 and 5 L test water, respectively. The suspensions were ultrasonically treated for 15 min and stirred between 48 and 73 h. Stock suspensions were filtered through a cellulose nitrate filter (pore size 0.45 µm). Adequate amounts of stock solution were diluted with test water to prepare the test media of the lower test concentrations.
- Eluate: no
- Differential loading: no
- Controls: yes, test water control - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: Originally supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany.
- Feeding during test
- Food type: Green algae (Scenedesmus subspicatus)
- Amount: Based on the total organic carbon (TOC) in the algal food suspension. 0.1 mg TOC/Daphnia (day 0,1), 0.15 mg TOC/Daphnia (day 5-8, 12-13), 0.2 mg TOC/Daphnia (day 2, 14-15, 19-20), 0.3 mg TOC/Daphnia (day 9), 0.4 mg TOC/Daphnia (day 16)
- Frequency: every day
ACCLIMATION
- Acclimation conditions: same as test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Test temperature:
- 21 °C
- pH:
- 7.8 - 8.5
- Dissolved oxygen:
- 7.7 - 8.9 mg/L
- Nominal and measured concentrations:
- nominal: 0, 6.25, 12.5, 25, 50, 100 mg/L
measured: 0.04 – 0.06 mg/L (day 0), 0.023 – 0.030 mg/L (day 7), 0.025 – 0.035 mg/L (day 16) - Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, 100 mL, headspace: 20 mL, fill volume: 80 mL
- Renewal rate of test solution (frequency/flow rate): renewed on day 2, 5, 7, 9, 12, 14, 16, 19
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to OECD guideline 211
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 400 - 420 lux
EFFECT PARAMETERS MEASURED: Mortality of adults and number of young daphnids was recorded every day. Offspring were removed at the same time.
RANGE-FINDING STUDY
- Other: A range-finding study was performed to determine the test concentrations for the definitive study. Results were not reported. - Reference substance (positive control):
- no
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 0.02 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mortality
- Details on results:
- - Mortality of parent animals: 0%
- Time to first brood release or time to hatch: between day 8 and 9 - Validity criteria fulfilled:
- yes
- Conclusions:
- After 21 days the NOELR was determined to be >= 0.02 mg/L and the EL50 was determined to be > 50 mg/L.
Referenceopen allclose all
The 21-day NOEC was determined to be at least up to the solubility of the test item in water.
No particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test.
In the analysed freshly prepared filtrate in the mean 0.03 mg test item/L were determined. During the test medium renewal periods of 48 and 72 h the concentrations were below the determination limit of 0.01 mg/L. The biological results are related to the mean measured test concentration of the undiluted filtrate, calculated as the average of all measurements during exposure period.
The 21-day NOEC was determined to be at least up to the solubility of the test item in water.
No particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test.
In the analysed freshly prepared filtrate in the mean 0.03 mg test item/L were determined. During the test medium renewal periods of 48 and 72 h the concentrations were below the determination limit of 0.01 mg/L. The biological results are related to the mean measured test concentration of the undiluted filtrate, calculated as the average of all measurements during exposure period.
Description of key information
No chronic effects to aquatic invertebrates up to the limit of water solubility.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Effect concentration:
- >= 0.02 mg/L
Additional information
Since no studies investigating the long-term toxicity to aquatic invertebrates of the test substance are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to another structurally related substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the analogue justification in IUCLID Section 13.
The study was performed according to the OECD Guideline 211 under GLP conditions (Hertl, 2001). Daphnia magna was exposed to individually prepared Water Accommodated Fractions (WAF’s) of nominal 6.25, 12.5, 25, 50 and 100 mg/L under semi-static conditions. Analytical determination of test solution concentration resulted in very low concentrations of 0.03 mg/L in freshly prepared medium and concentrations below the detection limit of 0.01 mg/L before test medium renewal periods after every 48 or 72 h, respectively. After 21 d, no particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test resulting in an EL50 of > 0.02 mg/L (measured, arithm. mean) and a NOELR of ≥ 0.02 mg/L (measured, arithm. mean).
Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile, it can be concluded that the test substance will not exhibit chronic effects to aquatic invertebrates up to the limit of water solubility.
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.