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EC number: 232-954-0 | CAS number: 9066-59-5
- 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
Description of key information
No chronic toxicity
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The lysozyme enzyme has been widely studied and a specific monograph is available. Two old complete chronic toxicity studies were performed on rats and dogs and are mentioned in the monograph; no details about the test procedures and substance composition are available, nevertheless the outcomes reached can be considered as reliable and representative.
Rats weighing an average of 100 g were distributed in groups of 10 males and 10 females each received 500 mg/kg p.o., 5 days a week for 5 months. Further 10 males and 10 females were used as control and treated with physiological saline, p.o. At the end of treatment all animals were sacrificed.
No weight differences were recorded in the treated groups in comparison with the control. Morphological blood studies revealed no differences between the treated and control animals. Glycaemia, azotaemia and the serum proteins remained unmodified.
Anatomical and histopathological examination of the lungs, heart, kidneys, liver and spleen showed no particular changes.
Dogs, i.e. fox terriers aged 1.5-2 years old, were distributed in groups of 4 animals (2 males and 2 females) treated with 100 or 500 mg/kg p.o., 5 days a week for 12 months. A further control group was treated with 5 ml/kg of water, p.o. At the end of treatment all animals were sacrificed. There were no signs of intolerance. Weight differences were the same in the treated groups and in the control one. The haematological and blood chemistry data (RBC, WBC, Hb, platelets, differential WBC, haematocrit, clotting time, total serum proteins, albumin/globulin ratio, glycaemia, azotaemia, electrolytes, chlorides, bilirubinemia, choleasterolemia, alkaline phosphatase, transaminases) did not deviate from normal in the treated and untreated animals, and the same applies to the parameters of liver and kidney functions. The weight of the individual organs confirmed the optimum tolerance to the test substance and the analogous conclusions could be deduced from the histological reports.
In general lysozyme can be regarded as the precursor of lysozyme hydrochloride; the transformation into the salt form does not significantly impact the chronic toxicity potential and it is expected that lysozyme and lysozyme hydrochloride share the same potential breakdown products via physical and biological process. Furthermore, it has to be taken into account that the lysozyme as such can be considered as a conservative representative, based on the greater bioavailability potential. After oral intake the extent of absorption via the gastrointestinal tract is determined by the lipophilicity of the substance that can be considered to be comparable for lysozyme and lysozyme hydrochloride. The oral mucosa has a thin epithelium and rich vascularity, which favour absorption; however, contact is usually too brief for substantial absorption. The following step regards the stomach, in which the strong acid pH conditions carry, in both cases, to the same unfolded enzyme structure, with the same salification grade.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Review of the scientific literature available.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.9 Specific target organ toxicity - repeated exposure section, substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement, on the basis of the weight of all evidence available, including the use of recommended guidance values, which take into account the duration of exposure and the dose/concentration, which produced the effect(s), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed.
Classification in Category 2 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur within the guidance value ranges as:
- Oral (rat): 10 < C ≤ 100 mg/kg bw/day
The guidance values refer to effects seen in a standard 90-day toxicity study conducted in rats.
No adverse effects were reported in rats administered with 500 mg/kg p.o., 5 days a week for 5 months.
In conclusion, the substance does not meet the criteria to be classified for repeated dose toxicity, according to the CLP Regulation (EC 1272/2008).
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