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EC number: 200-272-2 | CAS number: 56-40-6
- 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: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Test procedures in accordance with accepted standard methods, insufficiently documentation, statistical method not described.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were treated with the test substance subcutaneously for 30 days.
- GLP compliance:
- not specified
- 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
- IUPAC Name:
- glycine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 weeks old
- Weight at study initiation: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 ℃
- Humidity (%): 55 +/- 5 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 1 500 mg/kg bw/day
- No. of animals per sex per dose:
- male and female each 10 rats/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- In this study, egg albumin was also used as a test substance, but the data of the egg albumin were omitted.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
FOOD CONSUMPTION: No data
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- How many animals: 5 animals
CLINICAL CHEMISTRY: Yes
- How many animals: 5 animals
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- How many animals: 5 animals
HISTOPATHOLOGY: Yes
- How many animals: 5 animals - Other examinations:
- no
- Statistics:
- Statistics was used, but the method was not descibed in the article.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
No deaths were observed in all groups. At the begining of the dosing period, spontaneous locomotion, respiratory depression and ptosis were observed in both sexes receiving glycine (1500 mg/kg) from ca. 20 minutes after dosing till 3 or 4 hours later. These signs almost disappeared 10 days after dosing. Hardening or necrosis was observed at the injection site of the test substance treated groups and progressed to marked necrosis by the end of the injection period.
BODY WEIGHT AND WEIGHT GAIN: no effects
FOOD CONSUMPTION: The food consumption in the males of the 1500 mg glycine/kg group was temporarily slightly less than in the control group.
FOOD EFFICIENCY: not examined
WATER CONSUMPTION: not examined
OPHTHALMOSCOPIC EXAMINATION: not examined
HAEMATOLOGY:
The number of white blood cells was significantly increased in both sexes of the 1500 mg/kg bw/d dose group. Differential count of neutrophils in females of the high dose group was significantly increased and lymphocytes were significantly decreased when compared to controls. In males of the 100 mg/kg bw/d dose group, differential count of neutrophils was significantly increased and lymphocytes were significantly decreased when compared to controls.
CLINICAL CHEMISTRY: no effects
URINALYSIS: no effects
NEUROBEHAVIOUR: not examined
ORGAN WEIGHTS: Significantly increased weights of spleen were observed in both sexes in the 1500 mg glycine/kg group.
GROSS PATHOLOGY: no effects
HISTOPATHOLOGY: NON-NEOPLASTIC:
Slight cell infiltration in peri-bronchus, liver (glisson's sheath, hepatic lobule) or kidney, bile duct proliferation or sinusoidal dilatation in liver, vacuolation in adrenal gland, extramedullary hematopoiesis in spleen were observed among control and treated groups. No abnormal findings were found in brain, heart, pancreas, stomach, duodenum, rectum, femur, testis and ovary.
HISTOPATHOLOGY: NEOPLASTIC: no effects
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Effect level:
- 100 - 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
In both sexes receiving glycine, no deaths were found and the body weight gains were normal compared to the control groups during the dosing period. Necrosis were observed at injection sites in the glycine groups. Especially, in males and/or females received 1500 mg glycine/kg, increased number of white blood cells and of differential count of neutrophils, and increased spleen weight were detected, indicating the non-specific irritation caused by glycine. No histological findings were also detected in the glycine groups. See Tables 1 and 2.
Table 1. Hematological examination
Sex | Dose(mg/kg) | Erythrocyte | Leucocyte | Hemoglobin | Hemogramm | % | |
x 104/mm3 | x 102/mm3 | Sahli % | Neutrophil | Lymphocyte | |||
Male | Control (saline) | 0 | 1081 +/- 49.9 | 103 +/- 8.1 | 99 +/- 3.1 | 12 | 87 |
Glycine | 100 | 1014 +/- 51.4 | 107 +/- 7.0 | 95 +/- 1.4 | *26 | *71 | |
Glycine | 1500 | 1167 +/- 31.0 | *184 +/- 14.4 | 90 +/- 0.5 | 22 | 76 | |
Female | Control (saline) | 0 | 1119 +/- 51.5 | 89 +/- 9.5 | 103 +/- 1.7 | 11 | 88 |
Glycine | 100 | 1060 +/- 28.6 | 118 +/- 2.0 | 89 +/- 1.9 | 11 | 89 | |
Glycine | 1500 | 1167 +/- 60.0 | *181 ± 6.7 | 100 ± 2.9 | *24 | *73 |
*Significant difference from the control (P<0.05)
Table 2. Ogan weights
Sex | Group | Dose(mg/kg) | Spleen (g) |
Male | Control (saline) | 0 | 0.78 +/- 0.09 |
Glycine | 100 | 0.96 +/- 0.30 | |
Glycine | 1500 | *1.16 +/- 0.18 | |
Female | Control (saline) | 0 | 0.63 +/- 0.15 |
Glycine | 100 | 0.78 +/- 0.25 | |
Glycine | 1500 | *1.13 +/- 0.25 |
*Significant difference from the control (P<0.05)
Applicant's summary and conclusion
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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