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EC number: 939-516-4 | 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to guideline and/or standard method but was non-GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- No cytotoxicity was observed at 1000 ug/ml, the highest concentration tested.
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HGPRT gene
- 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 ug/mL
- Vehicle / solvent:
- water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without S-9 ethyl methanesulphonate; with S-9 dimethylbenzanthracene
- Details on test system and experimental conditions:
- SYSTEM OF TESTING
- Cell type: CHO-K1-BH4
- Proficiences: HGPRT gene
- Metabolic activation system: rat S-9
ADMINISTRATION:
- Dosing: 100, 200, 400, 600, 800 and 1000 ug/mL
- Number of replicates: not indicated
- Negative control: water (solvent)
- Positive control groups: without S-9 ethyl methanesulphonate; with S-9 dimethylbenzanthracene
- Treatment: 5 hours - Evaluation criteria:
- CRITERIA FOR EVALUATING RESULTS:
At least a three-fold increase in mutation frequency above controls in a dose dependent manner. - Statistics:
- No additional information available.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no evidence of cytotoxicity at 1000 ug/ml, the highest concentration tested
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - With metabolic activation: negative
- Without metabolic activation: negative
At 800 and 1000 ug/mL the mutation frequency was increased >= 3 fold (24E-06 and 6E-06, respectively) compared to controls (2E-06).
PRECIPITATION CONCENTRATION: not indiated
CYTOTOXIC CONCENTRATION: Not observed - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material did not meet the criteria set for a positive response set by the author of the report and was considered to be negative by the author. - Executive summary:
The test material was evaluated in the Chinese hamster ovary assay with and without metabolic activation. The test material did not meet the criteria set for a positive response set by the author of the report and was considered to be negative by the author.
Reference
The increased mutation frequency seen at the two highest concentrations (800 and 1000 ug/mL) in absence of a concentration response relationship are not considered biologically significant and do not fulfil the criteria for a positive response due to the absence of a dose-response relationship.
Table 1
Treatment and Concentration (ug/ml) | Cloning efficiency (%) | No. of mutants | Mutation Frequency (x10(-6)) |
Activation assay | |||
Negative control | 96 | 2 | 2 |
Solvent control (H2O) | 76 | 6 | 7 |
Positive control | 77 | 178 | 200* |
Glycerol | |||
100 | 65 | 6 | 7 |
200 | 66 | 0 | 0 |
400 | 77 | 2 | 3 |
600 | 63 | 3 | 4 |
800 | 72 | 7 | 9 |
1000 | 80 | 12 | 15 |
Non-activation assay | |||
Negative control | 75 | 4 | 5 |
Solvent control (H2O) | 84 | 2 | 2 |
Positive control | 79 | 122 | 153* |
Glycerol | |||
100 | 87 | 0 | 0 |
200 | 85 | 1 | 1 |
400 | 85 | 1 | 1 |
600 | 79 | 4 | 5 |
800 | 83 | 20 | 24* |
1000 | 83 | 5 | 6* |
* Values are at least three times that for the solvent control.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
There are no data for polyglycerine. Data are available for glycerol, the major component of target substance. Glycerol was negative in two separate Ames tests, a Chinese hamster ovary HGPRT assay, a Chinese hamster ovary SCE assay and an Unscheduled DNA Synthesis assay using rat hepatocytes. Given the lack of a mutagenic response in all the in vitro studies with glycerol, and the lack of a carcinogenic response in a chronic tox/carcinogenicity study with glycerol and with polyglycerol (as part of polyglycerol polyricinoleate) (the relevant read-across analogues), conduct of an in vivo mutagenicity study is not required since according to Column 2 of Annex VIII and IX, further genotoxicity testing in vivo is only required if there are positive findings in the in vitro studies. For more read-across justification and support, please refer to the attached justification document.
Justification for selection of genetic toxicity endpoint
Data from glycerol, the major component of polyglycerine target substance.
Justification for classification or non-classification
Classification for genetic toxicity according to GHS and the Directive 67/584/EEC (DSD) is not warranted. Data on the major component, glycerol, indicated no genotoxic responses. In addition, data from rodent cancer bioassays with glycerol and polyglycerol (as part of polyglycerol polyricinoleate) indicated no evidence of carcinogenic potential.
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