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Diss Factsheets
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EC number: 946-533-0 | CAS number: -
- 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:
- short-term repeated dose toxicity: oral
- Remarks:
- 5-day dose-range finding study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2007-04-16 to 2007-04-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The purpose of this study was to assess the tolerance of rats to exposure of the test item for 5 days. The results of this study were used to select the dose levels for the 28-day toxicity study.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine
- EC Number:
- 264-761-2
- EC Name:
- N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine
- Cas Number:
- 64265-45-8
- IUPAC Name:
- N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine
- Test material form:
- liquid
- Details on test material:
- - Physical state: liquid
- Analytical purity: 97.0%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 6 weeks.
- Fasting period before study: no
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNlFF Spezialdiaten GmbH, Soest, Germany
- Water (e.g. ad libitum): Free access to tap water.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was administered undiluted. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Dose selection rationale: Dose were based on the results of the acute oral toxicity study (report no. 484827)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 1 and 5
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean over days 1-5 diet consumption calculated as g food/kg body weight/day
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all animals assigned to the study
ORGAN WEIGHTS: Kidneys, Liver
HISTOPATHOLOGY: No
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- One animal in the 1000 mg/kg bw/d group showed salivation between Days 3 and 5. No further clinical signs noted.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Normal
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Normal
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Liver weights considered to be normal and kidney weights were considered to be slightly increased in the 1000 mg/kg group
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No abnormalities noted.
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- other: selection of dose levels for subsequent 28-day toxicity study
- Basis for effect level:
- other: Based on the results of this dose range finding study, dose levels of 0, 50, 150 and 1000 mg/kg bw/day were considered suitable for the subsequent 28-day toxicity tests in the Wistar rat.
- Remarks on result:
- not measured/tested
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this dose range finding study, dose levels of 0, 50, 150 and 1000 mg/kg bw/d were considered suitable for the subsequent 28-day toxicity test in the Wistar rat.
- Executive summary:
In a subacute toxicity study Amphopropionate C8 (50.6% a.i.) was administered to 3 female Wistar rats per dose orally by gavage once daily at dose levels of 500 and 1000 mg/kg bw/day for 5 consecutive days. The purpose of this study was to assess the tolerance of rats to exposure of the test item for 5 days. The results of this study were used to select the dose levels for the 28-day toxicity study.
All animals survived the scheduled study period. Treatment with the test item at the dose level of 1000 mg/kg bw/day caused a slightly increased kidney weight and one animal of the high dose group showed salivation between Day 3 and 5. No further test substance-related findings were detected or observed in clinical examinations, body weights, food consumption values and clinical pathology evaluations including organ weight analysis.
Based on these results, dose levels of 0, 50, 150 and 1000 mg/kg bw/d were considered suitable for the subsequent 28 day toxicity test.
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