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EC number: 203-539-1 | CAS number: 107-98-2
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study similar to OECD guideline 474.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxic and/or Epigenetic Effects of some Glycol Ethers: Results of different short-term tests
- Author:
- Elias, Z. et al.
- Year:
- 1 996
- Bibliographic source:
- Published inOccupational Hygiene, 2: 187-212
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1-methoxypropan-2-ol
- EC Number:
- 203-539-1
- EC Name:
- 1-methoxypropan-2-ol
- Cas Number:
- 107-98-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 1-methoxypropan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-propylene glycol-1-methyl-ether
- Analytical purity: 98%
- Impurities (identity and concentrations): 0.0 mg/l peroxide
- Composition of test material, percentage of components: alpha isomer: 98.1%, beta isomer: 1.2%
- Isomers composition: as described above
- Purity test date: not specified in the report
- Lot/batch No.: not specified in the report
- Expiration date of the lot/batch: not specified in the report
- Stability under test conditions: not specified in the report
- Storage condition of test material: not specified in the report
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at receipt: 7-10 weeks old
- Weight at receipt: approximately 25 g
- Housing: not specified in the publication
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: according to guideline
ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard conditions
- Humidity (%): standard conditions
- Air changes (per hr): standard conditions
- Photoperiod (hrs dark / hrs light): standard conditions
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- alpha-PGME was diluted in Hank's balanced salt solution (HBSS), pH 7.2
- Details on exposure:
- alpha-PGME was diluted in Hank's balanced salt solution (HBSS), pH 7.2 and the test doses were administered at a volume of 0.2 ml, intraperitoneally (single injection). The negative control animals were treated with HBSS and the positive group with cyclophosphamide at dose of 25 mg/kg body weight.
- Duration of treatment / exposure:
- single injection
- Frequency of treatment:
- once
- Post exposure period:
- 24, 48 and 72 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2500 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
4000 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5000 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
6000 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 4 males + 4 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The positive group with cyclophosphamide at dose of 25 mg/kg body weight.
Examinations
- Details of tissue and slide preparation:
- The 2 femurs were removed from each animal and bone marrows were flushed out with 0.2 ml FCS into a tube containing FCS. The cell suspensions in 2 ml FCS were 1/100 diluted in Hanks PBS, pH 7, and spun down onto the slide at 650 rpm for 5 minutes. Two patches/slide and two slides/animal were made. The slides were air-dried, fixed for 3 minutes in absolute methanol and stained with May-Grunwald's stain.
- Evaluation criteria:
- The slides were coded prior to scoring. At least 1000 polychromatic erythrocytes (PCE) per animal were scored and the micronucleated PCE were counted. In addition, the ratio of PCE to mature normochromatic erythrocytes were determined by counting approximately 2000 eryhthrocytes
- Statistics:
- standard statistical methods
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- At the highest dose of 6000 mg/kg, mortality (3/8) was observed at 48 hours.
Any other information on results incl. tables
Table 1: Results of micronucleus test
Compound | Dose | Micronucleated PCE (ppt) | PCE/NCE ratio | ||||
P GME | 24 hours | 48 hours | 72 hours | 24 hours | 48 hours | 72 hours | |
2500 | 0.11 (0.10) | 0.54 (0.28) | - | 1.17 (0.07) | 1.30 (0.07) | - | |
4000 | 0.36 (0.18) | 0.33 (0.16) | - | 1.06 (0.07) | 1.22 (0.09) | - | |
5000 | 0.12 (0.10) | 1.03 (0.33) | - | 1.04 (0.05) | 1.03 (0.23) | - | |
6000 | 0.53 (0.20) | 0.69 (0.42) | - | 0.96 (0.09) | 0.60 (0.20) | - | |
Hanks | - | 0.53 (0.27) | - | - | 1.33 (0.09) | - | - |
CP | 25 | 9.90 (1.33) | - | - | 1.27 (0.07) | - | - |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
There was no increase in the frequency of micronuclei in polychromatic erythrocytes harvested from bone marrow of mice treated with propylene glycol methyl ether and hence the test material was classified as negative - Executive summary:
2-propylene glycol-1-methyl-ether was evaluated for gentoxicity in a micronucleus test in mice at doses from 2500 - 6000 mg/kg and there was no increase in the frequency of micronuclei in polychromatic erythrocytes harvested from bone marrow of mice treated with PGME and hence PGME was classified as negative
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