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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The following summarises the test data collected for the close analogue, losartan potassium. Maternal NOEL= 25 mg/kg/day. The F1 and F2 NOAEL is considered to be 25 mg/kg/day based on slight decreased pup weights (5.8-7.8%) during Days 14 to 21 of lactation and slight (4.3%) decrease in F1 body weight during 1-9 weeks postweaning. The results of the female rat fertility study suggest that developmental toxicity are indicative of potential fetal toxicity late in pregnancy and/or during the early lactation timeframe. These effects are suitable for classification of losartan free acid, by read-across, as fertility reprotoxicant according to CLP and DSD.
Justification for selection of Effect on fertility via oral route:
Maternal NOEL= 25 mg/kg/day. The F1 and F2 NOAEL is considered to be 25 mg/kg/day based on slight decreased pup weights (5.8-7.8%) during Days 14 to 21 of lactation and slight (4.3%) decrease in F1 body weight during 1-9 weeks postweaning.
Effects on developmental toxicity
Description of key information
LFA is the acid form of the drug losartan which is an angiotensin converting enzyme (ACE) receptor blocker. The following description of information on losartan potassium applies to the similar substance, losartan free acid, by read-across.
In the Oral Developmental Toxicity Study in Rats, there was no evidence of developmental toxicity based on postimplantation survival, fetal weight and external, visceral or skeletal examinations of fetuses in all treatment groups (control, 50 mg/kg/day, 100 mg/kg/day and 200 mg/kg/day).
In the Oral Developmental Toxicity Study in Rabbits, developmental toxicity occurred in the form of decreased fetal body weight and delays in fetal ossification in the 40 mg/kg/day treatment group. However, maternal toxicity manifested in the 40 mg/kg/day treatment group, and the decreased fetal body weight and delays in fetal ossification are likely coincident with the maternal toxicity.
In the Oral Fertility Study in Female Rats, there were no treatment-related effects on reproductive performance, including mating or fertility in F0 female rats given 25 mg/kg/day. There was no evidence of teratogenicity in any dose group in the F1 or F2 generations. Developmental toxicity was observed in all dose groups (25mg/kg/day, 100 mg/kg/day and 300/200 mg/kg/day) which were dose and time-dependent in nature. The timing and nature of the effects on the F1 generation observed during this study suggest that the toxicity observed may be due to late gestational/lactation exposure.
The results of the female rat fertility study suggest that developmental toxicity are indicative of potential fetal toxicity late in pregnancy and/or during the early lactation timeframe. These results with the close analogue, losartan potassium, lead to classification by read-across of losartan free acid as Reprotox 1B and Effect on or via lactation on the basis that ACE drugs acting directly on the renin-angiotensin system can cause harm to the developing fetus.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 40 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- These data are used to conservatively estimate developmental toxicity due to exposure to LFA.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Maternal toxicity manifested in the 40 mg/kg/day treatment group, and the decreased fetal body weight and delays in fetal ossification are likely coincident with the maternal toxicity
Justification for classification or non-classification
Based on the results obtained in a female rat fertility study with statistically significant effects observed to the developing foetus and clinical data (not included in REACH dossier) indicating that ACE drugs which directly act on the renin-angiotensin system causing harm to the developing foetus, LFA has been classified as
Reprotox 1B and effect on or via lactation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures ('CLP') and as R61 - May cause harm to the unborn child;
R64 - May cause harm to breastfed babiespecific effect if known > <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>according to Directive 67/548/EEC (‘DSD’).
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.
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