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EC number: 608-271-2 | CAS number: 28861-00-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990-1991
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP. The study is one week shorter than recommended. The concentration of the test material in the food is not precisely determined. Only one sex was examined insted of both. Evaluation of clinical signs, pathology is less then guideline recommendation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Principles of method if other than guideline:
- The study is one week shorter than recommended. The concentration of the test material in the food is not precisely determined.
Only one sex was examined insted of both. Evaluation of clinical signs, pathology is less then guideline recommendation. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-
- EC Number:
- 608-271-2
- Cas Number:
- 28861-00-9
- Molecular formula:
- C13H18N2O5
- IUPAC Name:
- Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-
- Details on test material:
- Name of test material (as cited in study report): Ureido-karbonsav
- Substance type: organic
- Physical state: white crystalline powder
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 197.75 +/- 9.33 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): LATI food
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: mixed with food
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): max. 5 days storage.
- Mixing appropriate amounts with (Type of food): 125 or 250 mg/kg doses mixed in 8 g/100 g food.
- Storage temperature of food: room temperature, in dark glass. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- daily feeding
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
250 mg/kg
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
125
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10-12 male rats,
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: acute per os LD50: 5000 mg/kg, 1/20; 1/40XLD50
- Rationale for animal assignment (if not random):
- Rationale for selecting satellite groups:
- Post-exposure recovery period in satellite groups:
- Section schedule rationale (if not random):
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: 0-12 week
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations:
- Dose groups that were examined: 1/20 LD50; 1/40 LD50
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 6 week, 12 week
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters checked Glu, Htk, Fvs, Se, St, Jn, Eo, Mo, MNS were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:
- Animals fasted: No data
- How many animals:
- Parameters checked: Glu, Htk, Fvs, Se, St, Jn, Eo, Mo, MNS were examined.
URINALYSIS: No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations:
- Dose groups that were examined: 1/20 LD50; 1/40 LD50
- Battery of functions tested: sensory activity / grip strength / motor activity / other: peripheral nerve conductivity
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes - Statistics:
- Probit analysis to determine subacute per os LD50.
t-probe method.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality, no signs.
BODY WEIGHT AND WEIGHT GAIN
Slightly decreased body weight gain compared to control group.
Coltrol group body weight gain was 271 %.
1/40XLD50 dose body weight gain 250 %.
1/20XLD50 dose body weight gain 256 %.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Not measured.
FOOD EFFICIENCY
Not measured.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study).
Not measured.
OPHTHALMOSCOPIC EXAMINATION
Not examined.
HAEMATOLOGY
Heamatokrit, qualitative and quantitative white count, SE, St, Jn, Eo, Mo, MNS was determined.
Effects was not observed compared to control group and the normal values.
CLINICAL CHEMISTRY
Blood glucose was tested in both control and 1/20XLD50, 1/40XLD50 doses at 6th week, and 12th week.
Significant difference was not observed compared to control group.
URINALYSIS
Not determined.
NEUROBEHAVIOUR
Learning process was examined by labyrinth methodology. No harmful effects was observed to the learning process of rats.
Peripheral nerve activity was observed by electromyography. Effects was not observed compared to control group, and the measured values at beginning of the study.
ORGAN WEIGHTS
Relative organ weight (brain, thymus, lung, heart, spleen, kidney, testes) was determined.
Significant decrease was observed in liver (13%), and spleen (16%) relative organ weight at dose 1/20xLD50.
HISTOPATHOLOGY:
Abnormality in thymus and lung tissue was observed. In thymus: increase in lymphoproliferative centers.
In lung: interstitialis-, broncho-, lipoid pneumonia and splitting of alveoli.
Effect levels
open allclose all
- Dose descriptor:
- dose level: LD50/20
- Effect level:
- other: not determined
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: See effects at Section Details on results.
- Dose descriptor:
- dose level: LD50/40
- Effect level:
- other: not determined
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: See effects at Section Details on results.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Subacute 12th week feeding study was performed on male rats.
Performance and evaluation of the study has limited relaibility.
Results has not shown significant harmful effect of the substance.
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