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EC number: 485-140-4 | CAS number: 515815-48-2
- 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 aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15- 18 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with an internationally established guideline (OECD, see below). BIBR 277 CL is the hydrochloride of BIBR 277 SE (Telmisartan, free acid).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 144701-48-4
- Cas Number:
- 144701-48-4
- IUPAC Name:
- 144701-48-4
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Telmisartan (4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]- [1,1'-biphenyl]-2-carboxylic acid;
- Molecular weight (if other than submission substance): 541.63 g/mol
- Substance type: white to yellowish crystalline powder
- Physical state: solid
- Analytical purity: 99.9 %
- Purity test date: 14 May, 2003
- Lot/batch No.:1007523
- Expiration date of the lot/batch: September 2005
- Stability under test conditions:
- Storage condition of test material: room temperature, dark and dry
- Other:
test item is not well soluble in test water
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- HPLC-UV measurements were carried out at the start and the end of the test.
Determined measured concentrations were 83% - 111% of the nominal test concentration.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A supersaturated stock suspension of nominal 100 mg/test item/L was prepared by suspending 50.2 mg test item in to 500 mL test water and stired for 24 hours. The undissolved test tiem was separated by filtration (cellulose nitrate filter , pore size 0.45 µm). the filtrate was used as stock solution
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmusw subspicatus CHODAT
- Strain: No. 86.81 SAG
- Source (laboratory, culture collection): Pflanzenphysiologisches Institut der Unversität Göttingen, Germany
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: cultivated under standardized conditions according to test guidelines ; inoculation of a biomass of 10000 algal cells per mL test medium, taken from a exponentially growing pre-culture, which was set up threee days before test start
ACCLIMATION
- Acclimation period:
- Culturing media and conditions (same as test or not):
- Any deformed or abnormal cells observed:
Study design
- Test type:
- static
- Water media type:
- saltwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- none
Test conditions
- Hardness:
- 0.24 mmol/L (024 mg/L) as CaCO3
- Test temperature:
- 23 °C
- pH:
- 8.0 - 10.3
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 50mL Erlenmeyer flasks containing 50mL test solution
- Type : closed with glass dishes
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- Initial cells density: 1 * 10 exp.5 algal cells per mL test medium
- Control end cells density: 189.7 * 10exp.4 cells /mL after 72 hrs
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity and quality: 8600 -8740 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: spectrophotometer, determined at 24, 48, 72 and 96 hrs.
TEST CONCENTRATIONS
- Range finding study: was performed
- Test concentrations: 9.18; 4.71, 2.70, 1.03, 0.49, 0.25 and 0.12 mg test item/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (historic control)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.492 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.249 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 96 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.463 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.426 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.492 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.249 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.409 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.754 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control (for algal test): yes/no
- Observation of abnormalities (for algal test): none - Results with reference substance (positive control):
- no EC50 data given in study report.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item had a statistically significant inhibitory effect on the growth of Desmodesmus subspicatus (reduction of biomass) adter the exposure period of 96h, first at the concentration of .049 mg/L. Thus, the test concentration was determined as the 96h- LOEC.
The 96h NOEC was determined at the concentration of 0.25 mg/L, since up to and including this test concentration, the mean biomass of the algae was statistically not significantly lower than in the control. The 72h LOEC and NOEC were also calculated.
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