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EC number: 247-045-4 | CAS number: 25498-49-1
- 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
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:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to GLP and equivalent to OECD guideline 471.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver homogenate
- Test concentrations with justification for top dose:
- 0, 0.01, 0.1, 1, 10, or 100 mg per plate (or 0, 10, 100, 1000, 10000, or 100000 µg/plate)
- Vehicle / solvent:
- none (test material solutions were prepared in distilled water)
All positive controls were prepared in DMSO. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosogluanidine (TA100, TA1535/-S9); 2-nitrofluorene (TA98, TA 1538/-S9); Quinacrine mustard (TA1537/-S9) ; 2-anthramine (TA100, TA1535/+S9); 2-acetylaminofluorene (TA98, TA 1538/+S9); 8-aminoquinoline (TA1537/-S9)
- Details on test system and experimental conditions:
- Type: Ames test
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 30 min
- Incubation period: 48 hours
NUMBER OF REPLICATIONS:
3 replicates per dose
DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn evaluation
- Evaluation criteria:
- Concentrations of the test chemical which are overtly toxic are easily visualized as showing no bacterial growth on the plate (i.e. absence of background lawn). Lower levels of toxicity may be seen as a thin or sparse bacterial lawn, a reduction in the number of revertants, or the appearance of microcolonies (overgrown background lawn). Positive and negative controls were run concurrently with the test chemical, and appropriate responses for these controls are prerequesites for evaluating the response of the bacteria to the test chemical.
A test chemical is considered a bacterial mutagen if both the mean number of revertant colonies observed is at least three times higher than the mean of the negative (solvent) control and at the same time it produces a dose response relationship over several concentrations. If a chemical produces reproducible reversion rates in excess of 3x over background, but no definitive dose response relationship, it is considered to be a presumptive bacterial mutagen. If a chemical produces reproducible reversion rates greater than 2x but less than 3x over the negative controls, the results are considered to be equivocal or inconclusive. Test substances failing to meet the above criteria are considered non-mutagenic in this system. - Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: in the absence of S9 cytotoxicity was observed at 100mg/plate in all the strains and at 10mg/plate in TA 98 and TA 1538. in the presence of S9 cytotoxicity was observed at 100mg/plate in TA 98, TA 100 and TA 1535.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Tripropylene glycol methyl ether did not cause mutations in the pre-incubation Ames plate assay with or without S-9 metabolic activation. - Executive summary:
Dowanol TPM (tripropylene glycol methyl ether) was evaluated for genetic activity in the Ames test with and without the addition of a metabolic activation preparation using a pre-incubation assay. The studies were conducted using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538.Frozen stock cultures of Salmonella typhimurium (from Bruce Ames, U California, Berkeley) were transferred to nutrient rich broth and incubated at 37C until reaching a prespecified optical density at 650 nm (108 to 109 cells/ml). This was done for each of the four tester strains (TA98, TA100, TA1535, & TA1537). To optimize contact between the bacteria and TPM, the preincubation modification was employed. This entailed 1) mixing TPM, the S-9 activation system (when appropriate), and the bacteria in a tightly capped culture tube, 2) incubating this mixture for 30 minutes at 30°C, 3) adding supplemental top agar, then 4) pouring the mixture onto plates. Plates were incubated at 37C for two days during which time histidine independent revertant colonies developed. TPM concentrations of 0, 10, 100, 1000, 10000, or 100000 µg/plate in distilled water were tested.The activation system consisted of the 9000 x G supernatant of Aroclor 1254 induced rat liver homogenate (Litton Bionetics). Positive control substances were included in the study design to verify the sensitivity of the test organisms. Under conditions without activation, positive control substances included 1) N-methyl-N’-nitronitrosoguanidine for strains TA100 and TA1535 (10 µg/plate), 2) 2notrofluorene for strains TA98 and TA1538 (100 µg/plate), and 3) quinacrine mustard dihydrochloride for strain TA1537 (10 µg/plate). Under conditions with activation, positive control substances included 1) 2-anthramine for strains TA100 and TA1535 (10 µg/plate), 2) 2-acetylaminofluorene for strains TA98 and TA1538 (100 µg/plate), and 3) 8-aminoquinoline for strain TA1537 (25 µg/plate).
Colonies were counted with an Arteck Model 880 colony counter. Results were considered positive if the number of colonies exceeded three times background for any of the strains at any dose and if a dose response relationship was observed over several doses in any strain, with or without S-9 activation. In addition the positive response had to be reproducible in a second experiment. Results were considered negative if the revertant counts did not exceed background for any tester strain and the negative response was reproducible in a second experiment.
The validity of the assay was assessed by determining that 1) negative and positive control revertant counts fell within historical control counts and 2) toxicity did not interfere with interpretation of results.Toxicity was elicited in all tester strains without activation at 100 mg/plate (100000 µg/plate) and at 10 mg/plate (10000 µg/plate) in strains TA98 and TA1538. With activation, toxicity occurred at the highest concentration only 100 mg/plate (100000 µg/plate) in strains TA98, TA100,& TA1535.
TPM did not cause mutations in the plate assay with or without S9 metabolic activation. A repeat experiment with the five tester strains confirmed these results.
Cytotoxis concentration:
Without activation:
100 mg/plate (100000 µg/plate) in all strains and at 10 mg/plate (10000 µg/plate) in strains TA98 and TA1538
With activation:
100 mg/plate (100000 µg/plate) in strains TA98, TA100, & TA1535TPM was not mutagenic in any of the strains of bacteria, in either the avtivated or nonactivated assays.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
All in vitro genoxicity studies conducted with tripropylene glycol methyl ether are of high quality and reliable without restrictions. The results of all studies were consistent. Tripropylene glycol methyl ether did not induce gene mutations in bacterial and mammalian cells. No increase in UDS or SCE was observed with this test material.
No chromosome aberration study in mammalian cells is available for tripropylene glycol methyl ether (TPGME). Therefore, studies on propylene glycol methyl ether (PGME) and dipropylene glycol methyl ether (DPGME) are used as surrogates for TPGME. The glycol ethers PGME, DPGME and TPGME are closely related in molecular structure and physicochemical properties and thus, the potential for toxicological effects. These are liquids with similar boiling points, moderate volatility, and high water solubility. Increasing boiling point and vapor pressure are consistent with increasing molecular weight. No differences in gene mutation potential have been observed between other glycol ethers families (e.g. mono- and di-propylene glycol n-propyl ethers and mono-, di- and tri-propylene glycol n-butyl ethers). The results obtained with propylene glycol ethers in gene mutation studies were consistently negative. Therefore, it is justified to use the gene mutation studies conducted with PGME and DPGME for read-across purposes to fill the data gap for TPGME. Negative results were obtained in the chromosome aberration studies in mammalian cells conducted with PGME and DPGME. These results are supported by the negative findings in the CHO/SCE study conducted with TPGME.
No in vivo studies are available.
Justification for selection of genetic toxicity endpoint
This study was conducted according to GLP and equivalent to OECD guideline 471
Justification for classification or non-classification
Tripropylene glycol methyl ether was not mutagenic in bacteria (Salmonella typhimuriumTA 1535, TA 1537, TA 1538, TA 98, and TA 100) and in mammalian cells, and no cytogenetic effect were observed in mammalian cells. The data available indicates that tripropylene glycol methyl ether is not genotoxic.
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