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EC number: 701-316-8 | 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- This endpoint study record is part of a Weight of Evidence approach comprising of read-across from four analogue source substance studies. The results of the read-across studies agree as to the repeated dose toxicity potential and are sufficient to fulfil the information requirements as further explained in the provided repeated dose toxicity endpoint summary.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative toxicity of synthetic and natural glycerin
- Author:
- Hine CH, Anderson HH, Moon HD, Dunlap MK, Morse MS
- Year:
- 1 953
- Bibliographic source:
- Arch Ind Hyg Occup Med 7:282-291
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Version / remarks:
- Test material was administered in the diet for up to 2 years. Study design followed intent of OECD 452. The number of animals/dose level used was less than required and minimal histopathology was conducted.
- GLP compliance:
- no
- 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:
- Propane-1,2,3-triol
- Details on test material:
- GLYCERINE USP grade
Constituent 1
- Specific details on test material used for the study:
- Reported as: glycerin
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)
- Number of animals: 22/sex/treatment, 26/sex for controls
- Source: Institute of Experimental Biology of University of California
Upon arrival at the laboratory, each rat was assigned to an individual numbered cage. Distribution among the experimental groups was accomplished by reference to a standard random number table.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION / EXPOSURE
- Exposure period: 2 year (1 year for the high dose group)
- Route of administration: oral in diet. Diet consisted of a standard dog-food meal with which the glycerin was thoroughly mixed. Feed was prepared once a week and stored in stoneware crocks. The crocks were weighed and refilled weekly, and the unconsumed feed was discarded.
- Doses: 5, 10 and 20% in diet; males 2000, 4000 and 8000 mg/kg bw, females 2500, 5000 and 10000 mg/kg bw
- Water was allowed freely. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Continuous
- Frequency of treatment:
- Daily for up to two years
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- males: 5% nominal in diet
- Dose / conc.:
- 2 500 mg/kg bw/day (nominal)
- Remarks:
- females: 5% nominal in diet
- Dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- Remarks:
- males: 10% nominal in diet
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- Remarks:
- females: 10% nominal in diet
- Dose / conc.:
- 8 000 mg/kg bw/day (nominal)
- Remarks:
- males: 20% nominal in diet
- Dose / conc.:
- 10 000 mg/kg bw/day (nominal)
- Remarks:
- females: 20% nominal in diet
- No. of animals per sex per dose:
- 22/sex/treatment
26/sex for controls - Control animals:
- yes, concurrent no treatment
- Details on study design:
- No additional information available
- Positive control:
- No Data
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 hr 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:
- glycogen and lipid content of the liver of surviving rats at 0 and 20% glycerol
- Statistics:
- Chi-square test, student t-test, ANOVA (Fisher) were used as appropriate
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- slightly increased (significant) in males at 5 and 10% natural glycerin
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- 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 abscesses, 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
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- 1 Year
- Effect level:
- 10 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: 20% in diet for 1 year
- Dose descriptor:
- NOEL
- Remarks:
- 2 year
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: 10% in diet for 2 years
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The study authors concluded that the administration of 10% (equivalent to 5,000 mg/kg bw/day) of SS1 via the diet for two years did not induce any adverse effects in rats. Based on the results, a no observed effect level (NOEL) was determined to be 10,000 mg/kg bw/day (20% in diet) for 1 year.
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