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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
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
- Analytical purity: > 96%
- Impurities (identity and concentrations): not determined
- Supplier: Aldrich Chemical Co., Inc. Milwaukee, WI
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Weight at study initiation: 204.49-259.42 g on GD 0
- Housing: individually in solid-bottom polycarbonate cages with stainless steel wire lids (Laboratory Products, Rochelle Park, NJ) and Ab-Sort-Dri cage litter (Laboratory Products, Garfield, NJ)
- Diet: Purina Certified Rodent Chow # 5002, ad libitum
- Water: deionized filtered water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 72 F
- Humidity (%): 54%
- Photoperiod (hrs dark / hrs light): 12 /12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations were stored at room temperature in amber glass bottles and used within the demonstrated period of stability
VEHICLE
- Deionized water
- Concentration in vehicle: 0, 160, 400 and 1000 mg/ml (target concentration)
- Pre-dose analysis of dosing solution demonstrated the dose concentrations to be within a range of 93-106% of target concentrations.
- Amount of vehicle (if gavage): 5 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1
- Length of cohabitation: overnight
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal lavage referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Gestation days 6-15
- Frequency of treatment:
- Once daily
- Duration of test:
- Till gestation day 20
- No. of animals per sex per dose:
- 20-25 females/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on previous studies, the concentrations of DPG were anticipated to cause some maternal toxicity at the higher dose while the lowest dose was expected to produce no maternal or developmental toxicity.
- Rationale for animal assignment (if not random): stratified randomization so that mean GD 0 body weights did not differ significantly among dose groups.
- Other: the study was performed in two replicates with one breeding date in the first replicate and three consecutive breeding dates in the second replicate. The brereding date for the first replicate and the first breeding date of the second replicate were 28 days apart.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily from GD 6
BODY WEIGHT: Yes
- Time schedule for examinations: in the mornings of GD 0, 3, 6, 9, 12, 15, 18 and 20
FOOD AND WATER CONSUMPTION: Yes
Food and water weights were reported in the mornings of GD 0, 3, 6, 9, 12, 15, 18 and 20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: the maternal body, liver and intact uterus were weighed.
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes, all per litter
- Soft tissue examinations: Yes, all per litter
- Skeletal examinations: Yes, all per litter
- Head examinations: Yes, half per litter - Statistics:
- Maternal and fetal parameters: general linear models ANOVA.
Prior to GLP-ANOVA analysis, an arcsine-square root transformation was performed on all litter-derived percentage data to normalize the means and Bartlett's test for homogeneity of variance was performed on all data to be analyzed by ANOVA. When ANOVA revealed a significant (p < 0.05) dose effect, Dunnett's Multiple Comparison Test was used to compare treated to control groups. One-tailed tests were used for all pair-wise comprisons except maternal body and organ weights and fetal body weight. Nominal scale measures were analyzed by a X-square test for independence and by a test for linear trend on proportions. When a X-2 test showed significant experiment-wise differences, a one-tailed Fisher's exact probability test was used for pair-wise comparisons of treatment and control groups.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
One animal in the 2000 mg/kg bw/day and 2 animals in the 5000 mg/kg bw/day died after dosing on GD 14.
Clinical signs observed in confirmed-pregnant animals during and after exposure to 2000 and 5000 mg/kg bw/day of dipropylene glycol included ataxia, weight loss, lethargy, unstable gait, piloerection, morbidity and/or mortality). Significant reduction of body weight after the onset of dosing occurred exclusively in the high dose group from GD 9 through GD 20. Body weight gain of the high dose group animals paralleled control at significantly reduced levels from GD 9 through GD 20. The decreased body weights in the high dose group animals caused a significant decrease in maternal body weight gain throughout gestation (GD 0 -20) and during treatment (GD 6-15). Corrected maternal weight gain was still significantly reduced in the 5000 mg/kg bw/day group even after correction for the weight of the gravid uterus.
Relative (g/kg bw/day) maternal water intake was significantly increased over controls in the 5000 mg/kg/day group from GD 9-12, GC 12-15 and GD 15-18.
Animals exposed to 5000 mg/kg bw/day of dipropylene glycol consumed significantly less food from GD 6 to 9 and GD 9 to 12. As a result, relative food consumption was also decreased in these animals during the same periods, and body absolute and relative food consumption were decreased during treatment and throughout gestation. Absolute food consumption was decreased in the animals from the 2000 mg/kg bw/day group from GD 6 to 9, but relative food consumption was unaffected.
Necropsy of maternal animals on GD 20 showed significantly increased relative liver weights when compared to controls.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no significant differences between the exposed groups and the control in the average number of corpora lutea, implants, live fetuses, early deaths (resorptions), late deaths, or non-live implants per litter. The percent pre- and post-implantation losses per litter were not significantly different from control values.
A significant decreasing linear trend from the control to high dose group was observed for mean fetal weight. The male and female body weights in the DPG exposed groups were not significantly different from control. Although not significant, the mean male and female body weights per litter from the 5000 mg/kg bw/day were decreased to about 95% of control values (males 3.69 vs. 3.90 and females 3.47 vs. 3.67 g/fetus/litter, respectively). There were no other treatment-related effects evident at laparotomy.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- NOAEL is the highest dose
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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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