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EC number: 250-705-4 | CAS number: 31566-31-1
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- 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: Acceptable, well documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- The genotoxic activity of glycerol in an in vitro test battery
- Author:
- Doolittle, D.J. et al.
- Year:
- 1 988
- Bibliographic source:
- Food Chem Toxicol. 1988 Jul;26(7):631-5
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- limited documentation; the highest concentration was 1000 µg/mL without evidence of precipitate and/or cytotoxicity.
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
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:
- - Name of test material (as cited in study report): glycerol
- Analytical purity: > 99.5%
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S-9
- Test concentrations with justification for top dose:
- 100, 200, 400, 600, 800 and 1000 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: ethyl methanesulphonate; +S9: dimethylbenzanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 5h
- Expression time (cells in growth medium): not reported
- Selection time: not reported
- Fixation time (start of exposure up to fixation or harvest of cells): not reported
SELECTION AGENT: not reported
STAIN: not reported
NUMBER OF REPLICATIONS: 1
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A test result was considered positive if the test material induced at least a three-fold increase in mutation frequency above the solvent control in a dose-dependent manner.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
The increase in mutation frequency observed at 800 and 1000 µg/mL in the absence of metabolic activation were not considered biologically significant and did not fulfil the criteria set for a positive response due to the lack of a dose-response relationship. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Results of the HGPRT assay
Cloning efficiency (%) |
No. of mutants |
Mutation Frequency (x10(-6)) |
|
Without metabolic activation |
|||
Negative control |
75 |
4 |
5 |
Solvent control |
84 |
2 |
2 |
Glycerol (µg/mL) |
|||
100 |
87 |
0 |
0 |
200 |
85 |
1 |
1 |
400 |
85 |
1 |
1 |
600 |
79 |
4 |
5 |
800 |
83 |
20 |
24* |
1000 |
83 |
5 |
6* |
Ethyl methanesulphonate (100 µg/mL) |
79 |
122 |
153* |
With metabolic activation |
|||
Negative control |
96 |
2 |
2 |
Solvent control |
76 |
6 |
7 |
Glycerol (µg/mL) |
|||
100 |
65 |
6 |
7 |
200 |
66 |
0 |
0 |
400 |
77 |
2 |
3 |
600 |
63 |
3 |
4 |
800 |
72 |
7 |
9 |
1000 |
80 |
12 |
15 |
Dimethylbenzanthracene (5 µg/mL) |
77 |
178 |
200* |
* At least three-fold increase compared with the solvent control
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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