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EC number: 256-367-4 | CAS number: 49553-76-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 21 March - 4 April 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles (14 day study for dose selection for 3 month and 2 year studies).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Principles of method if other than guideline:
- Rats are exposed to the test substance for 14 days by a relevant route to identify potential toxicities and target organs and to assisst in setting doses for 90 day studies. 5 treatment groups with 5 animals per sex (male and female) and a control group recieving the vehicle are treated, observed, weighed and necropsied at the end of treatment.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- IUPAC Name:
- 1,1'-oxydipropan-1-ol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): dipropylene glycol
- Physical state: clear colorless liquid
- Analytical purity: 99 %
- Impurities (identity and concentrations): 0.08 % ± 0.01 % water
- Isomers composition: diastomer ratios - 35:52:13 (1,1'-oxybis(2-propanol):2-(2-hydroxypropoxy)-1-propanol:2,2'-oxybis(1-propanol))
- Lot/batch No.: 0365
- Stability under test conditions: stable up to 96 hours as dose formulations stored exposed to light in drinking water bottles fitted with Teflon-lined septa and sipper tubes at room temperature
- Storage condition of test material: at room temperature protected from light in amber glass containers
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: 7 weeks
- Weight at study initiation: mean - 130.5 g (male), 107.2 g (female)
- Housing: 5 animals per cage in solid-bottom polycarbonate cages (Lab products Inc., Maywood), changed twice weekly containing hardwood chips
- Diet: NIH-07 open formula pelleted diet (Zeigler brothers Inc. Gardeners, PA), ad libitum
- Water: Charcoal-filtered deionized water via amber glass bottles with plastic Teflon-lined caps and stainless steel sipper tubes, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: mixing dipropylene glycol with deionized water
DIET PREPARATION
- Rate of preparation of diet (frequency): at least every 2 weeks
- Mixing appropriate amounts with: deionized water
- Storage temperature of formulations: stored in carboys, protected from light, at room temperature for up to two weeks - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of the dose formulations were conducted using GC. During the 2 week study the dose formulations were analyzed twice (prepared formulations and samples taken from animal rooms).
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once daily, 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
5000, 10000, 20000, 40000, 80000 ppm
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
635, 1450, 2650, 5850, 13000 mg/kg bw (male)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
850, 1670, 2860, 5420, 11100 mg/kg bw (female)
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: recorded daily
BODY WEIGHT: Yes
- Time schedule for examinations: initially, on day 8 and at the end of the study
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: measured over a 24 hour period on days 5, 7 and 10 - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes; on all animals, organs weighed were the right kidney and liver
HISTOPATHOLOGY: Yes; performed on the brain, kidney, liver and testes and from all organs that showed evidence of gross lesions - Statistics:
- Organ and body weights were analyzed using the parametric multiple comparison procedures of Dunnett (Dunnett, C.W. (1955). A multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 50, 1096-1121) and Williams (Williams, D.A. (1971). A test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics 27, 103-117; (1972). The comparison of several dose levels with a zero dose control. Biometrics 28, 519-531).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- in some male rats at highest dose
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- in some male rats at highest dose
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- less compared to control in highest dose group in males and females
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- increased liver and kidney weights
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- minimal focal fatty change in livers of males
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
no animal died during the study, hypoactivity, piloerection and perinasal staining (males only) were observed at 13000 mg/kg bw
BODY WEIGHT AND WEIGHT GAIN
the final mean body weights and body weight ganins of males and females exposed to 13000 and 11100 mg/kg bw, respectively were significantly less than control (see table1)
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
water consumption was similar between all groups, some measurements were inaccurate due to leaking water bottles
ORGAN WEIGHTS
liver and kidney weights of males and females generally increased with increasing exposure concentrations (liver weights (absolute and relative) - male: 2650 mg/kg bw and greater; female: 5420 mg/kg bw and greater; kidney weights - male: 5850 mg/kg bw (absolute and relative); female: 5420 mg/kg bw (absolute)) (see table2)
HISTOPATHOLOGY: NON-NEOPLASTIC
Microscopically minimal focal fatty change was observed in livers of some males exposed to 2650 mg/kg bw or greater. It consisted of multiple small round clear spaces within the cytoplasm od midzonal hepatocytes (2650 mg/kg bw: 1/5; 5850 mg/kg bw: 2/5; 13000 mg/kg bw: 5/5)
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 450 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: liver and kidney weights, histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 2 860 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: liver and kidney weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table1: Survival and body weights
Concentration | Mean body weight in (g) | Final weight relative to controls | |||
(mg/kg bw) | Survival | Initial | Final | Change | (%) |
Male | |||||
0 | 5/5 | 133 ± 3 | 198 ± 5 | 66 ± 2 | |
635 | 5/5 | 130 ± 2 | 196 ± 3 | 66 ± 2 | 99 |
1450 | 5/5 | 128 ± 3 | 197 ± 4 | 69 ± 1 | 99 |
2650 | 5/5 | 131 ± 4 | 199 ± 5 | 69 ± 1 | 99 |
5850 | 5/5 | 128 ± 4 | 192 ± 4 | 64 ± 2 | 97 |
13000 | 5/5 | 133 ± 3 | 158 ± 2** | 24 ± 2** | 79 |
Female | |||||
0 | 5/5 | 107 ± 2 | 140 ± 2 | 33 ± 1 | |
850 | 5/5 | 109 ± 3 | 142 ± 2 | 33 ± 1 | 102 |
1670 | 5/5 | 108 ± 2 | 142 ± 2 | 34 ± 2 | 102 |
2860 | 5/5 | 107 ± 2 | 142 ± 2 | 35 ± 4 | 102 |
5420 | 5/5 | 106 ± 3 | 136 ± 3 | 30 ± 1 | 97 |
11100 | 5/5 | 106 ± 2 | 120 ± 3** | 13 ± 1** | 86 |
**Significant different (P<0.01) from the control group by Williams' or Dunnett's test
Table2: Organ weights and Organ-weight-to-body-weight Ratios
mg/kg bw (male) | 0 | 635 | 1450 | 2650 | 5850 | 13000 |
n | 5 | 5 | 5 | 5 | 5 | 5 |
necropsy body weigth | 194 ± 5 | 192 ± 3 | 194 ± 5 | 195 ± 4 | 190 ± 4 | 157 ± 2** |
Kidney | ||||||
absolute | 0.902 ± 0.019 | 0.912 ± 0.024 | 0.926 ± 0.037 | 0.990 ± 0.040 | 1.054 ± 0.021** | 1.206 ± 0.034** |
relative | 4.644 ± 0.091 | 4.756 ± 0.173 | 4.773 ± 0.100 | 5.069 ± 0.158 | 5.567 ± 0.151** | 7.680 ± 0.194** |
Liver | ||||||
absolute | 10.066 ± 0.475 | 10.580 ± 0.490 | 11.062 ± 0.457 | 12.290 ± 0.494** | 14.788 ± 0.610** | 15.692 ± 0.338** |
relative | 51.668 ± 1.384 | 55.011 ± 1.940 | 57.011 ± 1.294 | 62.868 ± 1.284** | 77.957 ± 2.559** | 99.933 ± 1.961** |
mg/kg bw (female) | 0 | 850 | 1670 | 2860 | 5420 | 11100 |
necropsy body weight | 138 ± 2 | 141 ± 2 | 141 ± 2 | 139 ± 2 | 134 ± 3 | 121 ± 3** |
Kidney | ||||||
absolute | 0.678 ± 0.027 | 0.692 ± 0.018 | 0.696 ± 0.022 | 0.706 ± 0.007 | 0.716 ± 0.020 | 0.766 ± 0.010 |
relative | 4.900 ± 0.143 | 4.903 ± 0.080 | 4.949 ± 0.117 | 5.101 ± 0.118 | 5.328 ± 0.103* | 6.351 ± 0.165** |
Liver | ||||||
absolute | 6.716 ± 0.259 | 7.034 ± 0.163 | 6.976 ± 0.159 | 6.948 ± 0.240 | 7.378 ± 0.118* | 9.244 ± 0.134** |
relative | 48.519 ± 1.178 | 49.865 ± 0.936 | 49.601 ± 0.426 | 50.136 ± 1.542 | 54.937 ± 0.481** | 76.545 ± 0.700** |
*Significant different (p<0.05) from the control group by Williams' test
**Significant different (p<0.01) from the control group by Willams' test
Applicant's summary and conclusion
- Conclusions:
- In the present study the test substance did not induce any treatment related deaths. However, effects on kidneys and liver were visible by increased organ weights observed at the end of the 14 day treatment period. The NOAEL for males anf females were determined to be 1450 and 2860 mg/kg bw, respectively.
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