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EC number: 412-420-5 | CAS number: 133909-99-6 TRITYL-LOSARTAN; TRITYL-MK0954
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V method B7 Directive 84/449/EEC
- Principles of method if other than guideline:
- Duration of test : 28 days
Limit test : 150 mg/kg or mg/l per h/day
Species / Strain : Sprague-Dawley Rats
Route of administration : Oral - Method of administration : Gavage
Vehicle : 1% w/v aqueous Methylcellulose
Dosing regime : 7 days per week - GLP compliance:
- yes
Test material
- Reference substance name:
- 2-butyl-4-chloro-4,5-dihydro-5-hydroxymethyl-1-[2'-(2-triphenylmethyl-1,2,3,4-2H-tetrazol-5-yl)-1,1'-biphenyl-4-methyl]-1H-imidazole
- EC Number:
- 412-420-5
- EC Name:
- 2-butyl-4-chloro-4,5-dihydro-5-hydroxymethyl-1-[2'-(2-triphenylmethyl-1,2,3,4-2H-tetrazol-5-yl)-1,1'-biphenyl-4-methyl]-1H-imidazole
- Cas Number:
- 133909-99-6
- Molecular formula:
- C41H37ClN6O
- IUPAC Name:
- [2-butyl-4-chloro-1-({2'-[2-(triphenylmethyl)-2H-1,2,3,4-tetrazol-5-yl]-[1,1'-biphenyl]-4-yl}methyl)-1H-imidazol-5-yl]methanol
Constituent 1
Results and discussion
Any other information on results incl. tables
CLINICAL OBSERVATIONS : No deaths occured. No signs of ill health or behavioural changes were noted. There is no notable difference in overall bodyweight gains between control and treated rats of both sexes. Food consumption for all treated rats was comparable to that of control animals.
LABORATORY FINDINGS : A statistically significant decrease in haemoglobin values for males at the 150 and 1000 mg/kg/day dose levels (i.e. P<0.05) was noted. Also, the thrombotest values for males at all 3 dose levels were reduced significantly (i.e. P<0.05 to P<0.01) compared to the controls.
Analysis of blood smears revealed the occurence of slight polychromasia and/or slight anisocytosis. However this finding is not uncommon among young laboratory rats and at the incidence seen in this study was not considered to be toxicologically important.
There were no notable differences in haematology for females treated compared to controls.
Elevated Alkaline phosphatase values occured at all dose levels for both sexes achieving significance (P<0.05) for high dose females.
Individual male animals exhibited raised Aspartate aminotransferase at all dose levels, achieving statistical significance for those at the 1000 mg/kg/day, while one female animal at 150 mg/kg/day also achieved an elevated AST level. A slight reduction in the glucose values for females at 15 and 150 mg/kg/day was noted compared to controls.
EFFECT IN ORGANS : Decreased adjusted kidney weights were recorded for males at 15, 150 and 1000 mg/kg/day achieving statistical significance compared to controls (P<0.05). Elevated weights for ovaries were noted and achieved statistical significance (P<0.05) at the 1000 mg/kg/day dose level. One male rat at 1000 mg/kg/day exhibited a slightly reduced liver weight (not statistically significant).
DOSE OR CONCENTRATION AT WHICH NO EFFECT WAS OBSERVED : 15 mg/kg/day
Applicant's summary and conclusion
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.
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