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Diss Factsheets
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EC number: 700-909-9 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted with a supporting substance, but according to the OECD guideline 401 and is fully GLP-compliant. As no study for the reaction mass of Glycyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-glycyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repitition of testing. As no synergistic or antagonistic effects from either of the main components are expected, the information derived from both main components is considered to be reliable for classification of the reation mass of Glycyl-L-glutamine and potassium chloride.
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)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- (2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid
- EC Number:
- 700-144-0
- Cas Number:
- 13115-71-4
- Molecular formula:
- C7H13N3O4
- IUPAC Name:
- (2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid
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
- Age at study initiation: males 8 weeks; females 9 weeks
- Weight at study initiation: males 150-164g; females 138-146g
- Fasting period before study: 16 hours before treatment
- Housing: individually in Macolon cages type II
- Diet (e.g. ad libitum): standard diet ad libitum, ssniff R, special diet for rats
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.6
- Humidity (%): 40-69
- Air changes (per hr): 12 hours artificial lighting / 12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqueous carboxymethylcellulose 0.5%
- Doses:
- 2370 mg/kg bw
5110 mg/kg bw - No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Mortality:
- Mortality in the 2370 mg/kg bw dose group:
no mortality
Mortality in the 5110 mg/kg bw dose group:
male: no mortality
female: 2/5 females died 3 hours post application - Clinical signs:
- other: After administration of 2370 mg/kg bw the only clinical symptoms were slight hypokinesia and decrease of muscle tone. In 4/5 male and 3/5 female animals no symptoms were detected After administration of 5110 mg/kg bw intoxication was characterized by sli
- Gross pathology:
- At necroscopy in individual male animals the testes appeared reduced in size.
- 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 occured 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 pbserved 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 occurence 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:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After oral application of the test substance the LD50 was above 5110 mg/kg bw for male and female rats.
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