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EC number: 601-329-8 | CAS number: 114798-26-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although the study was conducted according to GLP and well documented methods, " Practical guide 10: How to avoid unnecessary testing on animals", Section 3.3.2 states it is important that the reliability indicator (Klimisch score) reflects the assumptions of similarity. Thus, a score of 1 (reliable without restrictions) should normally not be used for results derived from read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Guinea Pig Maximizatoin Test described by Magnusson B. and Kligman A.M, 1969
- Principles of method if other than guideline:
- Doses: concentrations of 5% intradermally (Day 1) and 10% epicutaneously (Day 8)
On day 32, all animals were sacrificed by overdose of barbiturate. Skin samples restricted to flank application sites (ie-sites given rechallenge doses) were taken and fixed in 10% neutral buffered formalin.
Hematoxylin and eosin-stained sections from all sampled sites of all animals were evaluated microscopically. - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- L-158, 086-005H salt
- IUPAC Name:
- L-158, 086-005H salt
- Reference substance name:
- losartan
- IUPAC Name:
- losartan
- Details on test material:
- - Name of test material (as cited in study report):L-158,086-005H salt
- Analytical purity: 98% (HPLC)
- Lot/batch No.: 10
- Stability under test conditions: stable
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 290-320g
- Housing: Animals distributed in individual cages in an air-conditioned room
- Diet (e.g. ad libitum): UAR 114C Lab Chow
- Water (e.g. ad libitum):ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 deg C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% -intradermal; 10%-epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% -intradermal; 10%-epicutaneous
- No. of animals per dose:
- 10-control, 11-treatment
- Details on study design:
- MAIN STUDY.
A. INDUCTION EXPOSURE
- No. of exposures: 2 exposures (Day one-intradermal, Day 8-epicutaneous) Two 0.1 ml intradermal injections were given to each animal, one on each side of the dorsal midline.
- Exposure period:
- Test groups:
- Control group: Freund’s Complete Adjuvant diluted with an equal volume of distilled water.
- Site:
- Frequency of applications: weekly
- Duration:(injection)
- Concentrations: 5% in an emulsion formed by the mixing of the oil phase of Freund’s Complete Adjuvant with an equal volume of distilled water.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Days 22, 29
- Exposure period:24 h
- Test groups:
- Control group:
- Site: 2x2 cm patch on right (negative control) and left flank (treatment)
- Concentrations: 10% in petrolatum. A factor of 1.09 was used in preparing doses.
- Evaluation (hr after challenge): 24 and 48h
OTHER:
On day 32, all animals were sacrificed by overdose of barbiturate. Skin samples restricted to flank application sites (ie-sites given rechallenge doses) were taken and fixed in 10% neutral buffered formalin.
Hematoxylin and eosin-stained sections from all sampled sites of all animals were evaluated microscopically. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 11.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 11
- Clinical observations:
- scattered redness and no swelling
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 11.0. Clinical observations: scattered redness and no swelling.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 11
- Clinical observations:
- scattered redness and no swelling
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 11.0. Clinical observations: scattered redness and no swelling.
- Reading:
- other: rechallenge-second reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- scattered redness and no swelling
- Remarks on result:
- other: Reading: other: rechallenge-second reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: scattered redness and no swelling.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 11
- Clinical observations:
- 2@scattered redness, no swelling. 1@ diffuse redness, no swelling
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 3.0. Total no. in groups: 11.0. Clinical observations: 2@scattered redness, no swelling. 1@ diffuse redness, no swelling.
Any other information on results incl. tables
Post-mortem evaluation: epidermal and dermal changes typifying a contact dermatisis (slight acanthosis with very slight diffuse mononuclear cell infiltration of the upper dermis were seen in the left application sites of three animals from the treatment group. In two animals, it was associated with intraepithelial vesicle formation and positive skin reactions were recorded grossly for these two animals.
Very slight acanthosis was occasionally noted in other animals of this group as well as animals from the control group. Very slight acanthosis was judged as the result of non-specific irritation due to occlusive applications of petrolatum (vehicle).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Losartan potassium and therefore, losartan free acid by read-across, is considered as a mild sensitiser.
- Executive summary:
L-158, 086 (losartan potassium), and therefore, losartan free acid by read-across, is a considered a mild sensitizer at the concentrations tested in this study.
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