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EC number: 235-747-3 | CAS number: 12650-88-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From November 19, 2001 to March 5, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guideline .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- protocol deviation from 5 males and 5 females did not affect the quality or outcome of study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Lysozyme chloride
- IUPAC Name:
- Lysozyme chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Lysozyme Technical
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Specie & strain: Albino rat; Sprague-Dawley.
- Justification of Species: the rat is a representative rodent species preferred by various regulatory agencies for use in an acute oral study.
- Source: Texas Animal Specialities, Humble, TX.
- Quarantine period: 5 days.
- Age at study initiation: 51 days males and 22 days.
- Weight at study initiation: males: 181 - 326 g; females: 199-218 g.
- Housing: 1 per cage.
- Cage type: suspended, wire bottom, stainless steel.
- Diet: PMI Feeds Inc.TM Formulab #5008; available ad libitum except for approximately 16 hours before dosing.
- Water: municipal water supply analyzed by TNRCC Water Utilities Division; available ad libitum from automatic water system.
ENVIRONMENTAL CONDITIONS
Set to maintain
- Temperature: 22 ± 3°C.
- Humidity: 30 - 70%.
- Air changes: 10-12 air change/hour.
- Photoperiod: 12 hours light/dark cycle.
No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- TEST SUBSTANCE PREPARATION and ADMINISTRATION
The test substance was mixed with citric acid to produce a 40% w/v concentration.
An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 12.6 mL/kg.
Each dose was administered using an appropriately sized singe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing. - Doses:
- 5050 mg/kg (12.6 mL/kg).
- No. of animals per sex per dose:
- 6 males and 4 females (nulliparous and non-pregnant) for a single fixed dose.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for mortality and clinical/behavioural signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14.
- Necropsy of survivors performed: yes; on Day 14 after dosing, each animal was euthanized by an overdose of CO2. All study animals were subjected to gross necropsy and all abnormalities were recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 050 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality during the study. The estimated acute oral LD50, as indicated by the data, was determined to be greater than 5050 mg/kg.
- Clinical signs:
- other: Clinical signs included activity decrease, pilo-erection and respiratory chirp in both sexes, and diarrhea and sensitivity to touch in males. Animals were asymptomatic by Day 1.
- Gross pathology:
- The gross necropsy conducted at termination of the study revealed no observable abnormalities.
Any other information on results incl. tables
Reactions and Severity | Time after Treatment | ||||||||||||||||
hours | days | ||||||||||||||||
MALES | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
Activity decrease | 6 | 6 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Sensitive to touch | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diarrhea | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pilo-erection | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Respiratory chirp | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
FEMALES | |||||||||||||||||
Respiratory chirp | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Activity decrease | 4 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pilo-erection | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the Regulation 1272/08 (CLP). Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, Lysozyme Technical, was evaluated for its acute oral toxicity potential when administered to Albino rats. The acute oral LD50, as indicated by the data, is greater than 5050 mg/kg in males and females.
- Executive summary:
The test substance, Lysozyme Technical, was evaluated for its acute oral toxicity potential in albino rats when administered as a single gavage dose at a level of 5050 mg/kg to males and females.
No mortality occurred during the study.
Clinical signs included activity decrease, diarrhea, pilo-erection, respiratory chirp and sensitivity to touch, which were no longer evident by Day 1. There was no effect on body weight gain. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50, as indicated by the data, was determined to be greater than 5050 mg/kg.
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