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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-700-2 | CAS number: 1369492-55-6
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Remarks:
- The bioconcentration test was conducted solely to comply with non-EU national registration requirements.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 12 September 2013 to 22 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Details on sampling:
- Water samples were collected daily during the equilibration phase and during the first eight days of the uptake phase. Thereafter water samples were taken every two days. Additionally, a sample was taken at the end of the exposure phase after the exchange of the water before adding the fish (sample day 14 without test item). During the depuration phase water samples were taken on days 15 and 17. Representative control water samples were analyzed for test item (day -7, 0, and 14).
- Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- Considering the low solubility of the test item in purified water, stock solution and application solution were prepared in dimethylformamide (DMF).
Stock solution: 200 mg of the test item was dissolved in 100 mL of DMF (target concentration 2.0 mg/mL).
The application solution (0.2 mg/mL) was then prepared by diluting 84 mL of the stock solution to 840 ml DMF. The remaining stock solution was stored at approximately -20°C.
Appropriate portions (3-day and 4-day portions) of the application solution corresponding to 5 mg/day (20 μg/L) were stored at approximately -20°C. The application solution was renewed every Tuesday and Friday of the exposure phase. - Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- Species: Bluegill sunfish (Lepomis macrochirus)
Source: Osage Catfisheries, Inc., Osage Beach, Missouri, USA
Acclimatisation period: At least three weeks.
Treatment for disease: N one reported
Weight and length of fish prior to exposure period: Mean weight: 2.39 g
Mean length: 5.4 cm
Feeding: T etraMin, Tetra GmbH, D-49304 Melle, containing 8.0% lipid and 48.0% total protein, once daily at a rate of 2 % of the average fish body weight per day taking into account increasing body weights and decreasing number of fish per tank. - Route of exposure:
- aqueous
- Test type:
- flow-through
- Total exposure / uptake duration:
- 14 d
- Total depuration duration:
- 7 d
- Hardness:
- 174.9 mg/L as CaCO3 (measured once on day 19 of exposure).
- Test temperature:
- 19.7 – 24.6 oC
- pH:
- 8.1 – 8.3
- Dissolved oxygen:
- 5.5 – 9.4 mg/L
- TOC:
- <0.2(depuration period) – 33.5 – 41.3 mg/L (accumulation period)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: tanks
- Material, size, headspace, fill volume:
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 250 L/24hours
- No. of organisms per vessel: 118
- No. of vessels per concentration (replicates): one
- No. of vessels per control / vehicle control (replicates): one
OTHER TEST CONDITIONS
- Light intensity: 16 hours light and 8 hours dark, light intensity at light period approximately 500 Lux. - Nominal and measured concentrations:
- Nominal concentration: 20 µg subst./L.
During the equilibration phase of 7 days, test item levels in the treated tank ranged from 19.11 to 22.01 µg subst./L (95.6 and 110.1% of nominal). During the accumulation period (days 0 to 14) in the exposure tank, the test item concentrations amounted on average to 17.50 ± SD 2.24 µg subst./L (79% to 114% of the mean measured concentration). - Reference substance (positive control):
- no
- Conc. / dose:
- 17.5 µg/L
- Temp.:
- >= 19.7 - <= 24.6 °C
- Type:
- BCF
- Value:
- 111 dimensionless
- Calculation basis:
- steady state
- Conc. / dose:
- 17.5 µg/L
- Temp.:
- >= 19.7 - <= 24.6 °C
- Type:
- BCF
- Value:
- 111 dimensionless
- Calculation basis:
- kinetic
- Conc. / dose:
- 17.5 µg/L
- Temp.:
- >= 19.7 - <= 24.6 °C
- Type:
- BCF
- Value:
- 114 dimensionless
- Calculation basis:
- kinetic, corrected for growth
- Elimination:
- yes
- Parameter:
- DT50
- Depuration time (DT):
- 1.4 d
- Rate constant:
- growth-corrected depuration rate constant (d-1)
- Value:
- 0.508
- Details on kinetic parameters:
- - Uptake rate constant k(s):
- Depuration rate constant k(e): - Validity criteria fulfilled:
- yes
- Conclusions:
- The measured BCFss and BCFk values obtained for whole fish were 111 and 111, respectively. The lipid normalised (to 5%) BCFL based on BCFSS and BCFk were 74 and 73, respectively.
Depuration half-life (t0.50) was calculated to be 1.4 days based on k2a. The time to achieve 99 % depuration (t0.99) was calculated to be 9.1 days. - Executive summary:
The bioconcentration and depuration characteristics of the test item in the Bluegill Sunfish were investigated by means of a dynamic flow-through system. The bioconcentration in whole fish was calculated.
The fish were continuously exposed under flow-through conditions to the test item at a mean measured concentration of 17.50 μg/L for 14 days. After the exposure, the fish were transferred to flowing untreated water and the depuration of the material was monitored for a further 7 days. Temperature, pH and oxygen concentrations were monitored from day 0 to day 21; measurements ranged from 19.7-24.6 °C, 8.1-8.3 and 5.5-9.4 mg/L, respectively.
The overall temperature variation was slightly outside the limit of ± 2 °C. At the start of depuration the temperature was recorded as 19.7 °C. No other measurements were below 20.5 °C. It can be assumed that this short temperature deviation had no adverse effect on the study results.
Concentration of the test item during exposure in whole fish increased rapidly to levels ranging from 1.620 to 2.299 μg/g for time intervals day 4 to day 10. Fish concentrations decreased slightly to 1.781 and 1.647 μg/g on day 12 and 14 respectively. Concentration of the test item during depuration rapidly decreased to 0.150 μg/g on day 15 (day 1 of depuration) to below the limit of detection level on day 17 (day 3 of depuration).
A steady state plateau level (CfSS) based on time intervals 7, 10, 12 and 14 was calculated to be 1.936 ± 0.286 μg/g. The plateau level obtained by non-linear parameter estimation amounted to 1.934 μg/g.
The results can be summarized as follows:
Parameter Description Values kg growth rate constant; day-1 0.016 k1 overall uptake rate constant L kg-1 day-1 57.9 k2a overall depuration rate constant; day-1, based on accumulation data 0.524 k2d overall depuration rate constant; day-1, based on depuration data 2.369 k2g growth-corrected depuration rate constant; day-1 2.353 Cfss chemical concentration in fish at steady-state: μg g-1 1.936 Cw chemical concentration in the water mg L-1 17.50 Ln lipid normalisation factor 0.664 BCFss steady-state BCF; L kg-1 111 BCFssl lipid-normalised steady-state BCF; L kg-1 74 BCFk kinetic BCF; L kg-1 111 BCFkl lipid-normalised kinetic BCF; L kg-1 73 BCFkg growth-corrected kinetic BCF; L kg-1 114 BCFklg lipid-normalised growth-corrected kinetic BCF; L kg-1 76 t0.5g growth-corrected half-life; day 1.4
Reference
Description of key information
The fish embryo acute toxicity study was conducted solely to comply with a non-EU national registration requirements.
The measured BCFss and BCFk values obtained for whole fish were 111 and 111, respectively. The lipid normalised (to 5%) BCFL based on BCFSS and BCFk were 74 and 73, respectively.
Depuration half-life (t0.50) was calculated to be 1.4 days based on k2a. The time to achieve 99 % depuration (t0.99) was calculated to be 9.1 days.
Key value for chemical safety assessment
- BCF (aquatic species):
- 111 dimensionless
Additional information
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.