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EC number: 800-149-9 | CAS number: 1410795-90-2
- 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:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No individual data were included and microscopy was performed on distinct organs only.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative toxicity of synthetic and natural glycerin.
- Author:
- Hine, C.
- Year:
- 1 953
- Bibliographic source:
- Arch Ind Hyg Occup Med 7:282-291, 1953 (47)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Details on test material:
- CAS 56-81-5 (glycerine),
Natural glycerine, achieved from market stock, purity not
indicated (impurities were fatty acids and esters)
Synthetic glycerin, purity 99.5% (rest mainly water with
very small amounts of glycerin polymers and glyceraldehyde)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: not indicated
- Weight at study initiation: 96-109 g (males), 92-108 g
(females)
- Source: Institute of Experimental Biology of University of
California
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- - Exposure period: 2 year (1 year for the high dose group)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5, 10 and 20% in diet calculated to be equivalent to doses of: males 2000, 4000 and 8000 mg/kg bw, females 2500, 5000 and 10000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 22/sex/treatment, 26/sex for controls
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: daily in cage and weekly examination outside the home cage
- Mortality: daily
- Body weight: weekly
- Food consumption: weekly
- Haematology: erythrocyte and leucocyte count and haemoglobin after 3, 6, 12, 18 and 24 months
- Urinalysis: albumin, glucose, casts and red and white blood cells after 3, 6, 12, 18 and 24 months (24-48 urine collection) - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Organ weights: liver, kidneys, heart, spleen and lungs
- Macroscopic: no details provided
- Microscopic: liver, spleen, adrenals, kidney, small intestine, gonads and urinary bladder - Other examinations:
- OTHER EXAMINATIONS: glycogen and lipid content of the liver of surviving rats at 0 and 20% glycerol.
- Statistics:
- STATISTICAL METHODS: Chi-sqare test, student t-test, ANOVA (Fisher)
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):
- 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:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- effects observed, treatment-related
- 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:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- - Mortality and time to death: not indicated
- Clinical signs: not reported
- Body weight gain: no statistically significant differences between treated and control animals
- Food consumption: slightly increased (significant) in males at 5 and 10% natural glycerin
- Haematology: no treatment related effects
- Urinalysis: albumin: no significant treatment related effects (92% incidence in females at 20% natural glycerin compared to 54-64% in controls); glucose, casts, red and white blood cells: no treatment related effects
- Organ weights: incidental increases and decreases were reported without apparent relationship to treatment
- Gross pathology: no lesions related to treatment.
- Histopathology: Incidental bronchiectasis, pneumonia, pulmonary abcesses, taenia infestation of the liver, hydronephosis and pyelonephritis (total 27 rats were affected).
- Other: liver glycogen and lipid did not significantly differ between 0 and 20% glycerin (liver glycogen natural glycerin 4.2-4.3% and synthetic glycerin 3.7-4.2%)
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: absence of adverse effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effect has been reported in an chronic feeding studies in rat at concentrations up to 10.000 mg/kg bw.
- Executive summary:
In a chronic toxicity study glycerol was administered to 22 Long-Evans rats/sex/dose in diet at dose levels of 2000, 4000 and 8000 mg/kg bw for males and 2500, 5000 and 10000 mg/kg bw for females for 2 years (1 year for high dose group).
There were minimal compound related effects in food consumption, urinalysis, organ weights and histopahology and no compound related effects in other measured parameters. The NOAEL is 10000 mg/kg bw based on the lack of adverse effects.
This chronic study in the rat is acceptable and satisfies the guideline requirement for a chronic oral study (OPPTS 870.4100), OECD 452 in rodents. Deficiencies include no individual data included and microscopy was performed on distinct organs only.
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