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EC number: 700-144-0 | CAS number: 13115-71-4
- 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:
- 1992-11-19 to 1992-12-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 February, 1987
- Deviations:
- yes
- Remarks:
- only 2 dose levels but dose levels are sufficient for evaluation, maximum dose volume applied was 21.5 mL/kg bw
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- (2S)-2-(2-aminoacetamido)-4-carbamoylbutanoic acid
- EC Number:
- 700-144-0
- Cas Number:
- 13115-71-4
- Molecular formula:
- C7H13N3O4
- IUPAC Name:
- (2S)-2-(2-aminoacetamido)-4-carbamoylbutanoic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG, Borchen, Germany
- Age at study initiation: males 8 weeks; females 9 weeks
- Weight at study initiation: males 150 - 164 g; females 138 - 146 g
- Fasting period before study: 16 hours before treatment
- Housing: individually in Macrolon cages type II
- Diet: standard diet, ad libitum (ssniff R, special diet for rats)
- Water: drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.6
- Humidity (%): 40 - 69
- Photoperiod (per hr): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% (w/v)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 110 mg/mL (2370 mg/kg bw dose) and 237 mg/mL (5110 mg/kg bw dose)
- Amount of vehicle (if gavage): 21.5 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg bw
DOSAGE PREPARATION : The test item was suspended in the vehicle immediately before dosing, using a homogenizer and by shaking. - Doses:
- 2370 mg/kg bw (test item glycyl-L-glutamine monohydrate), equivalent to 2177 mg/kg bw anhydrous glycyl-L-glutamine
5311 mg/kg bw (test item glycyl-L-glutamine monohydrate), equivalent to 4879 mg/kg bw anhydrous glycyl-L-glutamine - 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: at 4 to 6 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), thereafter at weekly intervals up to the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopical examination included external appearance, body orifices, thoracic and abdominal cavities. Histopathology was carried out on the testes and epididymes of males, and the ovaries of females. - Statistics:
- no
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Remarks:
- test item glycyl-L-glutamine monohydrate
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 879 mg/kg bw
- Based on:
- other: anhydrous glycyl-L-glutamine
- Mortality:
- 2370 mg/kg bw: no deaths
5110 mg/kg bw: 0/5 males and 2/5 females died 3 h post-application. - Clinical signs:
- other: 2370 mg/kg bw: slight hypokinesia and decrease of muscle tone was observed in 1/5 males and 2/5 females. 5110 mg/kg bw: slight to severe hypokinesia, slight clonic convulsions, decrease of muscle tone, and loss of righting reflexes, restrained gait, piloe
- Gross pathology:
- 2370 mg/kg bw: In 2/5 male animals the testes appeared reduced in size.
5110 mg/kg bw: In 1/5 male animals the testes appeared reduced in size. A reddened lung was noted in the 2 deceased females.
The observations were considered toxicologically relevant and attributed to treatment. - Other findings:
- Testes:
The testes were affected by focal and/or diffuse atrophy of the seminiferous epithelium. In minimal to moderate cases degenerative changes were observed in spermatocytes and spermatids, resulting in a reduction or absence of these cells in specific stages of the seminiferous epithelium. Spermatocytes were predominantly affected in the zygotene stage of the meiotic cell division. Degenerative changes and a delay in the maturation of spermatids occurred in the first five stages of the cycle of the seminiferous epithelium. Affected tubules often had multinucleated giant cells. In marked to massive cases the epithelium of the seminiferous tubules consisted only of spermatogonia and Sertoli-cells or was characterized by the Sertoli-only change.
Diffuse atrophy of the seminiferous epithelium occured in 2/5 rats treated with 5110 mg/kg bw and in 5/5 rats treated with 2370 mg/kg bw. The finding was graded as marked to massive in animals of the high dose group and minimal to moderate in animals of the low dose group. Focal atrophy was observed in 1/5 and 3/5 animals treated with 5110 and 2370 mg/kg bw, respectively. It was graded slight to marked.
Epididymides:
The epididymides of animals of both dose groups had a treatment-related reduction of spermatosoma. This finding was associated with the occurrence of immature, multinucleated and degenerated speratids / spermatozoa. Four/5 and 5/5 animals treated with 5110 and 2370 mg/kg bw were affected by this change. It was graded slight to massive.
Ovaries:
The examined ovaries did not show any treatment-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After oral application of the test substance the LD50 was above 5110 mg/kg bw (test item glycyl-L-glutamine monohydrate), equivalent to 4879 mg/kg bw anhydrous glycyl-L-glutamine, for male and female rats.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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