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EC number: 947-659-9 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-01-26 to 1994-04-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- adopted 1992
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-glycyl-L-tyrosine
- EC Number:
- 211-525-1
- EC Name:
- N-glycyl-L-tyrosine
- Cas Number:
- 658-79-7
- Molecular formula:
- C11H14N2O4
- IUPAC Name:
- glycyl-L-tyrosine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hsd/Win:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 8 weeks; females: 9 weeks
- Weight at study initiation: males: 182-208 g; females: 149-169 g
- Fasting period before study: approx. 16 hrs before treatment
- Housing: individually in Macrolon cages, type II
- Diet (e.g. ad libitum): ad libitum, ssniff R, Special diet for rats (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (e.g. ad libitum): ad libitum, in drinking water quality from the Stadtwerke Halle, using an automatic drinking water system with drinking nipplesor drinking bottles
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.0
- Humidity (%): 43-67
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % Tylose® (Tylopur® C 1000 P, batch E 084 4357 and E 114 30100
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 and 215 mg/mL
- Amount of vehicle (if gavage): 10.0 mL/kg bw
- Lot/batch no. (if required): batch E 084 4357 and E 114 30100
MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg bw
DOSAGE PREPARATION (if unusual):The test substance was suspended in the vehicle immediately before dosing using a homogenizer (Ultraturrax, supplied by Janke & Kunkel, lKA-Werk, D-79219 Staufen) and an ultrasonic bath (Bandelin Sonorex RK 510 H, supplied by Bandelin Electronic, Berlin).
- Doses:
- 1000 and 2150 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- not observed
- Clinical signs:
- not observed
- Body weight:
- no changes in body weight gain
- Gross pathology:
- At necropsy no macroscopical alterations were detected.
Any other information on results incl. tables
Table 2: Number of animals dead and with evident toxicity
Dose |
Mortality (# dead/total) |
Number with evident toxicity(#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
|
1000 |
0/5 |
0/5 |
0/10 |
0/5 |
0/5 |
0/10 |
2150 |
0/5 |
0/5 |
0/10 |
0/5 |
0/5 |
0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this GLP study according to OECD guideline 401, N-glycyl-L-tyrosine dihydrate was administered by gavage to male and female Wistar rats at doses of 1000 and 2150 mg/kg bw. The animals were observed for 14 days after the single administration of the substance. No premature deaths occurred, no clinical signs of toxicity and at necropsy no macroscopical alterations were detected. Thus, the LD50 of N-glycyl-L-tyrosine dihydrate is considered to be > 2150 mg/kg bw corresponding to 2000 mg/kg bw N-glycyl-L-tyrosine.
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