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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 200-289-5 | CAS number: 56-81-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
- Principles of method if other than guideline:
- Two week aerosol study to set dose levels for a 13 week study. Study design appears to follow intent of OECD 412 but publication does not indicate that OECD 412 was followed.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: MMAD <1.5 um (respirable)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 6 hours/day
- Frequency of treatment:
- 5 days/week
- Remarks:
- Doses / Concentrations:
1000, 2000 and 4000 mg/m3
Basis:
nominal conc. - No. of animals per sex per dose:
- 10/sex/dose level
- Control animals:
- yes
- Dose descriptor:
- LOAEC
- Effect level:
- 1 000 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on local effects on the epithelium of the upper respiratory tract.
- Critical effects observed:
- not specified
- Conclusions:
- The LOAEL was 1000 mg/m3 based on local effects on the epithelium of the upper respiratory tract.
- Executive summary:
The subacute toxicity of glycerol was examined following aerosol exposure. The LOAEL was 1000 mg/m3 based on local effects on the epithelium of the upper respiratory tract.
ANALYSES:
- Actual dose level: 1000, 1930 and 3910 mg/m3 (98-100% of target)
- Homogeneity (uniformity): relative standard deviation 1.6-2.5% of mean
value
TOXIC
RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality: 2 males at 1000 mg/m3 and 1 male and 1 female at 2000 mg/m3
- Clinical signs: no treatment related effects
- Body weight gain: decreased in males and females at all concentrations
(58-28% in females)
- Food consumption: no treatment related effects
- Clinical chemistry: glucose decreased in females at all concentrations
(28-19%)
- Haematology: no treatment related effects
- Organ weights: no treatment related effects
- Gross pathology: no treatment related effects
- Histopathology: minimal to mild squamous metaplasia of the epiglottis
in males and females at 0, 1000, 1930 and 3910 mg/m3 (1/10, 13/18, 16/19
and 13/14, respectively). Although a dose-related increase in the
frequency of squamous metaplasia was not apparent, the frequency of mild
metaplasia was greatest at the top dose (7 animals with minimal and 6
with mild).
STATISTICAL RESULTS: all effects mentioned showed statistical
significance, except the decreased weight gain in males
Data source
Reference
- Reference Type:
- publication
- Title:
- 2-week and 13-week inhalation studies of aerosolized glycerol in rats
- Author:
- Renne R.
- Year:
- 1 992
- Bibliographic source:
- Inhal Toxicol 4:95-111
Materials and methods
- Principles of method if other than guideline:
- Two week aerosol study to set dose levels for a 13 week study. Study design appears to follow intent
of OECD 412 but publication does not indicate that OECD 412 was followed. - 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:
- propane-1,2,3-triol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remark on MMAD/GSD:
- MMAD / GSD: MMAD <1.5 um (respirable)
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 6 h
- Concentrations:
- 1000, 2000 and 4000 mg/m3
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 5 850 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: re-calculated from a 6 h exposure period
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 850 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality in any of the doses during the initial 6 h of exposure (day 1).
Mortality during the 14-day exposure period: 2 males at 1000 mg/m3 and 1 male and 1 female at 2000 mg/m3 (time of death not reported), all animals in the high concentration group survived the 14-day exposure period. - Clinical signs:
- other: no treatment related effects
- Body weight:
- Body weight gain: decreased in males and females at all concentrations (58-28% in females)
- Gross pathology:
- no treatment related effects
Any other information on results incl. tables
The 14 day inhalation study without mortality which used a high dose of 3900 mg/m3 for 6 hr/day 5 d/wk. Using Haber’s rule that purports that toxicity is a function of total exposure suggests that a 6 hr exposure to 3900 mg/m3 a value of 23400 mgxhr/m3 is derived. This can then be used to derive the concentration that would yield the same outcome if only 4 hr exposure, 5850 mg/m3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute inhalation toxicity of glycerin was examined in rats. An inhalation LC50 was not determined as there were no mortalities at the highest tested concentration ( 5.85 mg/L) which was above the limit concentration of 5 mg/L for aerosols as defined by the OECD guideline 403.
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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