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EC number: 246-770-3 | CAS number: 25265-71-8
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 1,1-Oxydi-2-Propanol
- Details on test material:
- - Name of test material (as cited in study report): Dipropylene glycol (DPG)
- Physical State: Liquid
- Source: The Dow Chemical Company, Freeport TX
- Lot/batch #: MF2501N6HS)
-Purity: 99.9%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: 8 weeks
- Housing: 2-3 per cage, in stainless steel cages
- Diet (e.g. ad libitum): Purina Certified Rodent Lab Diet #5002 (Purina Mills, Inc., St. Louis, MO) in pelleted form, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
- Acclimation period: 7days
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): 12-15 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The dosing solutions were prepared before dosing on day 1 of study and used for both consecutive days of dose administration. The concentrations of the test material in dosing solutions were verified using liquid chromatography with refractive index detection and external standard quantification - Duration of treatment / exposure:
- Single administration
- Frequency of treatment:
- Two consecutive days
- Post exposure period:
- All treated animals were sacrificed at 24 hours after the last administered dose for the collection of bone marrow sample.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 500, 1000 and 2000 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 50, 100 and 200 mg/ml
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
51.4, 104 and 197 mg/ml
Basis:
analytical conc.
- No. of animals per sex per dose:
- 6 males/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: cyclophosphamide monohydrate (CP)
- Source: Sigma, St. Louis, MO
- Route of administration: single oral gavage
- Doses / concentrations: 120 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The limit dose of 2000 mg/kg bw was selected as the high dose, based on the range-finding study in which groups of mice (4/sex/dose) were treated with target doses of 1000 and 2000 mg/kg bw of the test material on 2 consecutive days and observed for at least 72 h after dosing for any signs of toxicity. No remarkable observations of toxicity or mortalities among the treated animals during the in-life portion of the range-finding test were observed. Only males were used in the main test, as no difference between sexes was observed in the range-finding test.
DETAILS OF SLIDE PREPARATION: All slides were coded, scored an decoded upon completion to control for bias. Two thousand PCE were examined from each animal and the number of micronucleated polychromatic erythrocytes (MN-PCE) was recorded. Micronuclei were identified as darkly stained bodies with smooth contours and varying shapes such as round, almond, or ring. The ratio of PCE to NCE in the bone marrow was determined in the micronecleus test by examining 200 erythrocytes. The ratio was expressed as PCE * 100/ PCE +NCE - Evaluation criteria:
- The final interpretation of biological significance of the responses was based on both statistical outcome and scientific judgment.
- Statistics:
- The raw data on the counts of MN-PCE for each animal was first transformed by adding 1 to each count and then taking the natural log of the adjusted number. Depending on the results of the sex effect in the range-finding study, the transformed MN-PCE data and the data on percent PCE were analyzed by a two-way analysis of variance (when both sexes were used in the study) or a one-way variance (when only males were used). The sex by dose interaction in the two-way analysis was reviewed and if significant, a one-way analysis of variance was performed for each sex. If different dose levels of test material were used for each sex, the data was separated by sex prior to statistical analysis. Pairwise comparisons of treated vs. controle groups were done, if the dose effect was significant, by Dunnett's t-test, one sided (upper) for MN-PCE and twosided for the percent PCE. Linear dose-related trend tests were performed if any of the pairwise comparisons yielded significant differences. The alpha level at which all the tests were conducted was 0.01.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 1000 and 2000 mg/kg bw
- Clinical signs of toxicity in test animals: none
Any other information on results incl. tables
Table 1. Summary of the data on the frequencies of micronucleated polychromatic erythrocytes (MN-PCE), % polychromatic erythrocytes (% PCE), and body weight in mice treated with the vehicle (negative control), test material or cyclophosphamide monohydrate (positive control)
Dose (mg/kg/day) |
MN-PCE (mean ± SD)a |
% PCE (mean± SD) |
0b |
2.8 ± 2.5 |
60.7 ± 4.7 |
500 |
2.8 ± 1.9 |
57.6 ± 8.7 |
1000 |
1.3 ± 0.5 |
58.7 ± 4.5 |
2000 |
1.5 ± 1.4 |
52.0 ± 8.2 |
120 CPc |
40.0 ± 16.9d |
50.2 ± 6.7d |
a 2000 PCE were examined/animal for MN/PCE incidence and expressed as MN-PCE/2000 PCE
b Mice were dosed with the vehicle (distilled water)
c CP = Cyclophosphamide monohydrate (positive control)
d The MN-PCE and % PCE values were significantly different from the negative control (alpha = 0.01)
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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