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Diss Factsheets
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EC number: 227-842-3 | CAS number: 6000-44-8
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- See read across document in section 13
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Glycine
- EC Number:
- 200-272-2
- EC Name:
- Glycine
- Cas Number:
- 56-40-6
- Molecular formula:
- C2H5NO2
Constituent 1
- Specific details on test material used for the study:
- Glycine (lot M5G2082; purity 100.0%) purchased from Nacalai Tesque, Inc.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- All animals were housed individually in metallic bracket cages in a breeding room kept at temperature of 20 to 26°C and a relative humidity of 30 to 70%, with an air ventilation cycle of 10 to 15 times/hour (all-fresh air ventilation) and a 12-hour light/ dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 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)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Twice daily clinical observations (pre- and post-dose), body weights recorded on study days 1, 3, 8, 15, 22, 28, and on the day prior to necropsy. Food consumption and water consumption recorded on study days 2-3, 7-8, 21-22, and 27-28.
- Other examinations:
- Urinalysis, hematology, blood chemistry.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Daily urine volume and total amount of Cl excretion were significantly higher (p<0.05) in the 2000 mg/kg dose group, and urine pH and urinary protein showed lower trends in the glycine-treated groups. Not considered toxicologically significant as there were no correlations in histopathology in kidneys or urinary bladder or changes in the weights of those organs.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Once-daily oral administration of glycine up to 2000 mg/kg/day for 4 weeks to male SD rats (Crl: CD (SD)) caused no toxicologically significant change in the animals. The no observed- adverse-effect level of glycine is at least 2000 mg/kg .
- Executive summary:
Groups of 6 male rats were administered 500, 1000, or 2000 mg/kg bw/day glycine in water by oral gavage for 28 days. Clinical observations, body weights, food consumption, haematology, and urinalysis, and histopathology were performed. There were no effects on the measured parameters, and there were no deaths up to 2000 mg/kg bw/day.
NOAEL for male rats was 2000 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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