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EC number: 213-235-0 | CAS number: 931-40-8
- 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

Endpoint summary
Administrative data
Description of key information
Two key studies have been identified: one 90d oral toxicity study (K2, The Dow Chemical Company, 1962) and one subchronic toxicity by inhalation study (K2, Renne R., 1992), both performed with the read-across substance glycerol.
Repeated dose toxicity: oral:
The effect of glycerol following administration for 90 days in a subchronic toxicity study was examined (The Dow Chemical Company, 1962). The test has been performed with the read-across substance glycerol. Animals were exposed orally (via diet) to 0, 5 and 20 % of test substance in diet. A NOAEL of 4850 mg/kg was determined. This study was scored as K2 study (reliable with restrictions) because of read across purposes and was considered as the key study.
Repeated dose toxicity: inhalation:
The subchronic toxicity of glycerol was examined following aerosol exposure. Sprague-Dawley rats were exposed to 33, 165 and 660 mg/m³ (nominal concentration) of test item, during 6 hours/day, 5days a week for 13 weeks. The NOAEL was determined to be 167 mg/m³ (actual dose level) based on local irritant effects on the upper respiratory tract.
Repeated dose toxicity: dermal:
Key studies are available for the oral and inhalation routes of exposure (read across with glycerol). According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 4 580 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 167 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The information requirements of repeated dose toxicity of glycerine carbonate were covered with studies from the read-across substance glycerol.
Repeated dose toxicity: oral:
The effect of glycerol following oral administration was examined in a subchronic toxicity study. Test material was administered via the diet at 5 and 20% for 90 days. Body weights and feed consumption were measured at selected intervals. At necropsy, lung, heart, liver, kidney, spleen and testes absolute and relative weights were obtained. Basic hematologic and clinical chemistry measurements were made. Rats fed 5 or 20% glycerol in the diet gained weight at a faster rate than control animals. There were no adverse treatment related effects noted in male or female rats fed 5% glycerol in the diet. In the male rats which received 20 percent glycerol, there was an increase in the final liver/body weight ratio and upon microscopic examination generalized cloudy swelling and hypertrophy of the parenchymal cells was observed. The only effect in the female rats on this level was some generalized cloudy selling upon microscopic examination of the liver. A 5% glycerol in the diet corresponded to 4580 and 6450 mg/kg/day for male and female rats, respectively, after 4 weeks and a 20% glycerol in the diet corresponded to 18,750 and 25,800 mg/kg/day for male and female rats, respectively, after 4 weeks.
Repeated dose toxicity: inhalation:
Renne R. (1992) examined the subchronic toxicity of glycerol following aerosol exposure, at concentrations 33, 165 and 660 mg/m³ (nominal concentration). Sprague-Dawley rats were exposed to the test item during 6 hours per day, 5 days per week for 13 weeks. The NOAEL was 167 mg/m³ (actual dose level) based on local irritant effects on the upper respiratory tract.
Repeated dose toxicity: dermal:
Two key studies with the read-across substance glycerol are available for the oral and inhalation routes of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal or inhalation route of exposure.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one reliable study available with the read-across substance glycerol. The justification for this read-across is added to Section 13 of this substance dataset.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Only one reliable study available with the read-across substance glycerol. The justification for this read-across is added to Section 13 of this substance dataset.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Only one reliable study available with the read-across substance glycerol. The justification for this read-across is added to Section 13 of this substance dataset.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
A key study is available for the oral and inhalation route of exposure (read-across with glycerol). According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Key studies are available for the oral and inhalation routes of exposure (read across with glycerol). According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure.
Justification for classification or non-classification
The LOAEL (oral route) of the read-across substance glycerol is greater than 4850 mg/kg bw/day and the LOAEC of the read-across substance glycerol is 0.66 mg/l/6 h/d for the inhalation route of exposure (dust/mist/fume). These values are greater than the upper limits of the guidance value range in the CLP Regulation for STOT RE classification category 2 of a 90 day test via the oral and inhalation routes (100 mg/kg and 0.2 mg/l/6h/d respectively). Based on these read-across results, glycerine carbonate should not be classified as STOT RE.
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