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EC number: 423-460-8 | CAS number: 3508-98-3 SALICYNALVA
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a dietary reproscreening study (OECD TG 421) a NOAEL >70 mg/kg bw/d for males and > 80 mg/kg bw for females (the highest dose tested) has been derived at which no effects on fertility have been found, resulting in an overall NOAEL for fertility of at least 70 mg/kg bw.
In addition, in the 28-day repeated dose toxicity study no effects on male or female gonads were observed indicating the absence of fertility effects (NOAEL > 250 mg/kg bw).
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Quality of information is adequate because the information on fertility is available from the 28-day repeated dose toxicity study and the repeated dose reproscreen study, both according to the respective OECD guidelines under GLP, supporting the absence of effects for fertility.
Additional information
A reproscreen study according to OECD TG 421 has been conducted for the substance. Nominal values of 200, 400 and 1000 ppm have been administered via the diet. Chemical analysis showed mean accuracies of 67%, 71% and 77% for the diets of Groups 2, 3 and 4, respectively, which was below the criterion range 80-120%. Therefore the analysed concentrations were used for determining the doses resulted in circa 15, 30 and 70 to 73 mg substance/kg body weight/day for the males and 79 to 124 mg substance/kg body weight/day for the females. No toxicologically significant parental toxicity was observed up to the highest dose level tested. In the males liver weights were slightly increased but without microscopic changes. Therefore the liver effects were considered to be of an adaptive nature to administration of the test substance. No fertility toxicity was observed up to 70 mg/kg bw. Therefore a parental and fertility NOAEL of at least 70 mg/kg bw was established.
Effects on developmental toxicity
Description of key information
The developmental toxicity of Salicynalva was tested in a developmental / reproscreen study according to OECD TG 421 using dietary exposure. The exposure resulted in doses of circa 15, 30 and 80 mg/kg bw for dams. The dams showed no toxicologically significant effects up to the highest dose level tested. The increased liver weights at the highest dose was not accompanied with macroscopic or microscopic changes and were therefore considered to be an adaptive response to the test substance. No developmental toxicity was observed up to the highest dose tested. Treatment with Salicynalva by dietary administration in female Wistar Han rats at dose levels of circa 15, 30 and 80 mg/kg bw did not reveal maternal and developmental toxicity for treatment up to the highest dose. The No Observed Adverse Effect Level (NOAEL) of at least 80 mg/kg bw was established based on the actual test substance intake 79 to 124 mg substance/kg body weight/day for the dams.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The quality of the developmental reproscreen study is adequate because it has been performed according to the respective OECD guideline under GLP.
Justification for classification or non-classification
Based on the absence of effects on fertility in a reproscreening study, Salicynalva does not have to be classified as toxic to reproduction according to EU CLP (EC No. 1272/2008 and its amendments).
Based on the absence of effects on developmental toxicity in a reproscreen study, Salicynalva does not have to be classified as toxic for developmental toxicity according to EU CLP (EC No. 1272/2008 and its amendments).
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.
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