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EC number: 500-114-5 | CAS number: 52408-84-1 1 - 6.5 moles propoxylated
- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 19 May 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerol, propoxylated, esters with acrylic acid
- EC Number:
- 500-114-5
- EC Name:
- Glycerol, propoxylated, esters with acrylic acid
- Cas Number:
- 52408-84-1
- Molecular formula:
- (C3H6O)m(C3H6O)n(C3H6O)oC12H14O6
- IUPAC Name:
- Poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.',.alpha.''-1,2,3- propanetriyltris[.omega.-[(1-oxo-2-propenyl)oxy]]-
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: GK0561/158
Storage: Room temperature
Stability: guaranteed until June 8, 2005
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Aroclor 1254 induced rat liver
- method of preparation of S9 mix: a sufficient amount of S-9 fraction was thawed at room temperature and 1 volume of S-9 fraction is mixed with 9 volumes of S-9 supplement (cofactors). The concentrations of the cofactors in the S-9 mix are:
8 mM MgCl2
33 mM KCI
5 mM Glucose-6-phosphatase
4 mM NADP
15 mM Phosphate buffer (pH 7.4)
The phosphate buffer (6) is prepared by mixing an Na2HPO4 solution with an NaH2PO4 solution in a ratio of about 4 :1.
- S9 in the final culture medium : 0.5 mL
- quality controls of S9: To demonstrate the efficacy of the S-9 mix in this assay, the S-9 batch was characterized with benzo(a)pyrene - Test concentrations with justification for top dose:
- 20 µg - 5 000 µg/plate (Standard plate test)
20 µg - 5 000 µg/plate (Preincubation test) - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle:Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Sterility and Vehicle controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; N-methyl-N'-nitro-N-nitrosoguanidine; 4-nitro-o-phenylendiamine; 9-a minoacridine (AAC); 4-nitroquinoline-N-oxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension (soft agar;amino acid solution;test solution or vehicle;fresh bacterial culture; S-9 mix or phosphate buffer were mixed and poured onto agar plates)
DURATION (Preincubation and Standardtest were performed)
- Preincubation period: 20 min
- Exposure duration: 48h-72h
- Fixation time (start of exposure up cell count): 48h-72h
SELECTION AGENT: histidine
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (number of revertants were counted) - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain.
A test substance is generally considered nonmutagenic in this test if:
-The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.
Toxicity detected by a
- decrease in the number of revertants
- clearing or diminution of the background lawn (= reduced his- or trp- background growth)
- reduction in the titer
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- slight decrease in the number of revertantswas observed depending on the strain and test conditions at doses ≥ 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- slight decrease in the number of revertantswas observed depending on the strain and test conditions at doses ≥ 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: No precipitation was found.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : Please refer to Table 1 to 10.
Ames test:
- Signs of toxicity : A slight decrease in the number of revertants was occasionally observed in the standard plate test depending on the strain and test conditions at 5 000 pg/plate. In the preincubation assay a weak bacteriotoxicity (slight decrease in the number of revertants and / or a slight reduction in the titer) was observed depending on the strain and test conditions at doses > 2500 pg/plate.
- Individual plate counts: Please refer to Table 1 to 10
- Mean number of revertant colonies per plate and standard deviation : Please refer to Table 1 to 10
HISTORICAL CONTROL DATA
- Positive historical control data: Please refer to Table 11 to 15
- Negative historical control data: Please refer to Table 16 to 20
Applicant's summary and conclusion
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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