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A mixture of Propanoic acid, -1-methyl, 2-hydroxy-, (C12-14)-alkyl ester, Propanoic acid, 2-hydroxy-, 2-(C12-14-alkyloxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester and Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester
EC number: 941-488-3 | 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
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- 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
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- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-05-30 to 2007-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Gene of histidine-requiring S. typhimurium bacterial strains resulting in histidine-indpendant strains, and a gene of tryptophan-requiring E.coli bacterial strain resulting in a tryptophan-independent strain.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa: deep rough (defective lipopolysaccharide cellcoat), gal: mutation in the galatose metabolism, chl: mutation in notrate reductase, bio: defective biotin synthesis, uvrB: loss of the excision repair system (deletion of the ultraviolet-repair B gene).
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Dose range finding (+/- S9): 3 to 5000 µg/plate
Ist Expt (+/- S9): 3 - 1000 µg/plate
2nd Expt (+/- S9): 10 - 1000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not specified - Untreated negative controls:
- yes
- Remarks:
- Vehicle, DMSO, only
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO only (negative control)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See attached document: 07-006A; Positive control data
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: Not applicable
- Exposure duration: 48 h
- Expression time (cells in growth medium): 10E09 cells/mL
- Selection time (if incubation with a selection agent): Not applicable
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: reduction in bacterial background lawn, increase in size of the microcolonies and reduction of revertant colonies - Evaluation criteria:
- A response is considered negative if:
- the total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 and WP2uvrA is not greater than three (3) times the concurrent control.
- the negative response should be reproducible in at least one independently repeated experiment.
A response is considered positive if
- The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
- In case a positive response will be repeated, the positive response should be reproducible in at least one indepentently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- Not stated.
- 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:
- cytotoxicity
- Remarks:
- See attached document; 07-006A cytotoxicity data
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- See attached document; 07-006A cytotoxicity data
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitaion of the test material on the plates was observed at the start of the incubation period at concentrations of 333 µg/plate and upwards and at 1000 µg/plate and upwards at the end of the incubation period.
RANGE-FINDING/SCREENING STUDIES:
The test material was tested up to 5000 µg/plate, +/- S9 in the strains TA100 and WP2uvrA. In tester strain TA100, toxicity was observed at dose levels of 100 µg/plate, with and without S9. With WP2uvrA, no toxicity was observed at any dose levels tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
All control values were within laboratory historical control data ranges confirming that the test conditions were adequate and that the metabolic activation system functioned properly. - 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 is not mutagenic with or without metabolic activiation in bacteria under the conditions of the study. - Executive summary:
The test material dissolved in dimethyl sulfoxide (DMSO) was evaluated in the Salmonella typhimurium (strains TA1535, TA1537, TA98 and TA100) reverse mutation assay and the Escherichia coli (WP2uvrA) reverse mutation assay (with independent repeat) in the absence and presence of phenobarbital and beta-naphthoflavone induced rat liver S9 following OECD 471 and EC B13/14 Guidelines.
In a dose range-finding study the test material was tested up to 5000 µg/plate, +/- S9 in the strains TA100 and WP2uvrA. In tester strain TA100, toxicity was observed at dose levels of 100 µg/plate, with and without S9. With WP2uvrA, no toxicity was observed at any dose levels tested.
The test material precipitated at dose levels of 1000 µg/plate and above.
In the first experiment the test material was tested at a concentration range of 3 to 1000 µg/plate with and without 5% (v/v) S9 in strains TA1535, TA1537 and TA98. Toxicity was only observed in the tester strain TA1535 with and without S9 and in TA1537 without S9.
In the repeat assay with additional parameters the test material was tested in the concentration range 10 to 1000 µg/plate in the absence and presence of 10% (v/v) S9 -mix in strains TA1535, TA1537, TA98 and WP2uvrA and at 3 to 666 µg/plate (+/- S9) in tester strain TA100. Toxicity was observed in tester strains TA1535 without S9, and TA1537 and TA100 with and without S9.
The test material did not induce a signficant dose-related increase in the number of revertant (His+) colonies in each of the four S typhimurium tester strains and in the number of revertant (Trp+) colonies in the E.coli tester strain both with and without S9.
All control values were within laboratory historical control data ranges confirming that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that the test material is not mutagenic in vitro in bacteria with or without metabolic activation.
Reference
See attached document: 07-006A; Mutagenicity Response Tables
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro gene mutation in bacteria:
The substance, dissolved in dimethyl sulfoxide (DMSO) was evaluated in the Salmonella typhimurium (strains TA1535, TA1537, TA98 and TA100) reverse mutation assay and the Escherichia coli (WP2uvrA) reverse mutation assay (with independent repeat) in the absence and presence of phenobarbital and beta-naphthoflavone induced rat liver S9 following OECD TG 471 and EU Method B13/14.
In a dose range-finding study the substance was tested up to 5000 µg/plate, +/- S9 in the strains TA100 and WP2uvrA. In tester strain TA100, toxicity was observed at dose levels of 100 µg/plate, with and without S9. With WP2uvrA, no toxicity was observed at any dose levels tested.
The substance precipitated at dose levels of 1000 µg/plate and above.
In the first experiment the substance was tested at a concentration range of 3 to 1000 µg/plate with and without 5% (v/v) S9 in strains TA1535, TA1537 and TA98. Toxicity was only observed in the tester strain TA1535 with and without S9 and in TA1537 without S9.
In the repeat assay with additional parameters the substance was tested in the concentration range 10 to 1000 µg/plate in the absence and presence of 10% (v/v) S9 -mix in strains TA1535, TA1537, TA98 and WP2uvrA and at 3 to 666 µg/plate (+/- S9) in tester strain TA100. Toxicity was observed in tester strains TA1535 without S9, and TA1537 and TA100 with and without S9.
The substance did not induce a signficant dose-related increase in the number of revertant (His+) colonies in each of the four S typhimurium tester strains and in the number of revertant (Trp+) colonies in the E.coli tester strain both with and without S9.
All control values were within laboratory historical control data ranges confirming that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that the substance is not mutagenic in vitro in bacteria with or without metabolic activation.
Justification for selection of genetic toxicity endpoint
Only study available at Annex VII. It is a GLP guideline study.
Justification for classification or non-classification
On the basis of the available data (i.e. an in vitro gene mutation assay in bacteria) the substance does not require classification. The classification will be revisited when Annex VIII data are available.
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