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EC number: 211-519-9 | CAS number: 657-27-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Augustus 2002 - December 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with OECD guideline 408 (1998) and Directive 87/302/EEC No L133 (1988)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Directive 87/302EEC No L133
- Deviations:
- yes
- Remarks:
- there were a number of minor deviations that were not considered to have affected the validity of the study
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Lysine hydrochloride
- EC Number:
- 211-519-9
- EC Name:
- Lysine hydrochloride
- Cas Number:
- 657-27-2
- Molecular formula:
- C6H14N2O2.ClH
- IUPAC Name:
- lysine hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): Lys HCl crystals
- Physical state: white to pale yellow crystals
- Analytical purity: 99%
- Lot/batch No.: CP trial 13-14 November 2001
- Expiration date of the lot/batch: 1 November 2004
- Storage condition of test material: ambient temperature, under dry conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl (WI) WU BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland (Sulzfeld, Germany)
- Age at study initiation: 6-7 weeks
- Weight at study initiation:138-195 and 106-151 g for males and females, respectively
- Fasting period before study: no
- Housing: 5 animals per cage in macrolon cages with sterilized wood shavings as bedding material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr
IN-LIFE DATES: From: 28 August, 2002 To: 13 December, 2002
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: not applicable
DIET PREPARATION
- Rate of preparation of diet (frequency): monthly
- Mixing appropriate amounts with (Type of food): powdered diet
- Storage temperature of food: in a freezer (≤ 18◦ C) until use
VEHICLE
- Justification for use and choice of vehicle (if other than water): not applicable
- Concentration in vehicle: not applicable
- Amount of vehicle (if gavage): not applicable
- Lot/batch no. (if required): not indicated (test compound)
- Purity: 99% (test compound) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- stability, homogeneity, and concentration
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuous, via dietary admixture
Doses / concentrations
- Remarks:
- Doses / Concentrations:
-Dose/concentration: 0, 0.5%, 1.5% and 5% in diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- Treated animals: 10 males & 10 females; Control animals: 20 males & 20 females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: results of a range-finding study
- Rationale for animal assignment (if not random): not applicable
- Rationale for selecting satellite groups: not applicable
- Post-exposure recovery period in satellite groups: not applicable
- Section schedule rationale (if not random): not applicable - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily on working days, once daily on Saturdays and Sundays
- Cage side observations checked in table [No.?] were included. Not applicable
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly up to week 11-12
BODY WEIGHT: Yes
- Time schedule for examinations: before allocation to groups, on the first day of treatment, and weekly, thereafter until the end of the study, and on the day of necropsy
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/animal/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- gram weight gain per gram food: Yes
WATER CONSUMPTION : Yes
- Time schedule for examinations: week 1, 6 and 12
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to the start of treatment and towards the end of treatment (day 87)
- Dose groups that were examined: all animals prior to the start of treatment; control and high dose animals towards the end of treatment (day 87)
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at necropsy
- Anesthetic used for blood collection: Yes (CO2/O2)
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked in table [No.?] were examined. Standard parameters
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at necropsy
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked in table [No.?] were examined. Standard parameters
URINALYSIS: Yes
- Time schedule for collection of urine: days 85 (males) and 87 (females)
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked in table [No.?] were examined. Standard parameters
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: week 12-13
- Dose groups that were examined: all groups (10 animals/group and sex)
- Battery of functions tested: Functional Observational Battery (WHO/IPCS) + motor activity
OTHER: none - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Organ weights were determined. Feces were collected in weeks 2, 7 and 13 of the study and shipped to the sponsor on dry-ice
- Statistics:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- at compound intakes of 307, 914, 3002 mg/kg bw/day for males and 323, 968, 3173 mg/kg bw/day for females at low-, mid- and high dose, respectively
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- (see overall remarks)
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No treatment-related clinical signs observed and no mortalities
BODY WEIGHT AND WEIGHT GAIN: Similar in both control and treated animals
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Similar in both control and treated animals. Average compound intake: 307, 914, 3002 mg/kg bw/day for males and 323, 968, 3173 mg/kg bw/day for females at low-, mid- and high dose, respectively
FOOD EFFICIENCY: Similar in both control and treated animals, but lower in high-dose females in the first study week
WATER CONSUMPTION: increased in all treated groups except low-dose females, which was not considered to be of toxicological significance
OPHTHALMOSCOPIC EXAMINATION: no treatment-related changes
HAEMATOLOGY: No relevant differences from controls
CLINICAL CHEMISTRY: No relevant differences from controls
URINALYSIS: No relevant differences from controls (see overall remarks)
NEUROBEHAVIOUR: no indications of neurotoxicity
ORGAN WEIGHTS: decreased spleen weights at high dose in males were considered to be related to treatment and toxicologically significant
GROSS PATHOLOGY: No treatment-related findings
HISTOPATHOLOGY: NON-NEOPLASTIC: No treatment-related findings
HISTOPATHOLOGY: NEOPLASTIC (if applicable) : not applicable
HISTORICAL CONTROL DATA (if applicable) : not applicable
OTHER FINDINGS: none
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 914 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: organ weights
- Dose descriptor:
- NOAEL
- Effect level:
- 968 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: organ weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- The concentration of 1.5% in dietary admixture corresponding to a mean achieved dosage of 914 and 968 mg/kg bw/day for males and females, respectively, was considered a No-Observable-Adverse-Effect-Level (NOAEL) in this 90-day study in Wistar rats.
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