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EC number: 500-039-8 | CAS number: 25322-69-4 1 - 4.5 moles propoxylated
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant well-conducted and documented study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
- Principles of method if other than guideline:
- Propylene glycol was administered to pregnant mice at dose levels of 0.5, 5.0 and 10 ml/kg bw/day on gestation days 6 through 15. Mice were sacrificed on gestation day 18 and evaluation of fetuses, uterine weight, number of corpora lutea and implantation sites was performed.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- 1,2-Propanediol
- Reference substance name:
- monopropylene glycol
- IUPAC Name:
- monopropylene glycol
- Details on test material:
- - Name of test material (as cited in study report): propylene glycol
- Molecular formula (if other than submission substance): C3H8O2
- Molecular weight (if other than submission substance): 76.0942
- Smiles notation (if other than submission substance): C([C@@H](C)O)O
- InChl (if other than submission substance): InChI=1/C3H8O2/c1-3(5)2-4/h3-5H,2H2,1H3
- Substance type: organic
- Physical state: slightly viscous colorless liquid
- Analytical purity: 99.9%
- Batch number: 02907TT
- Storage: at room temperature in an environmentally controlled area
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc. (St. Constant, Canada)
- Age at study initiation: males 49 days old upon arrival, females 46 days old upon arrival
- Weight at study initiation: males 26-28 g, females 25-28 g upon arrival
- Housing: males were housed singly in stainless steel, wire mesh cages (23.5 x 40.0 x 18.0 cm); females were housed 2 to a gage in a stainless steel, wire mesh cages (23.5 x 20.0 x 18.0 cm) during acclimation.
- Diet (e.g. ad libitum): Ground, certified Rodent Chow #5002 (Purina Mills, Inc.) was available ad libitum during most of the acclimation period, and then powdered, certified AGWAY PROLAB animal Diet Rat, Mouse, Hamster 3200 (Agway Inc.) was available ad libitum for the duration of the study.
- Water: tap water (Municipal Authority of Westmoreland County, Greensburg, PA), ad libitum
- Acclimation period: ca. 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-77
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Propylene glycol was administered undiluted.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1
- Length of cohabitation: January 30 - February 3, 1991
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal and dropped copulation plug, referred to as day 0 of pregnancy - Duration of treatment / exposure:
- On gestation days 6 through 15
- Frequency of treatment:
- Daily
- Duration of test:
- 18 days
- No. of animals per sex per dose:
- 30 females/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a range-finding gavage study with propylene glycol in CD-1 mice (BRRC project 91-22-23801)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for morbidity and mortality. Prior to the treatment period, animals were observed for clinical signs once daily. During treatment, animals were observed for clinical signs immediately before and during dosing, and approximately 1 hour following each daily dosing period. Subsequent to the treatment period, animals were observed for clinical signs once daily (a.m.)
BODY WEIGHT: Yes
- Time schedule for examinations: gestation days 0, 6, 9, 12, 15, 18
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION: Yes
- Time schedule for examinations: gestation days 0, 3, 6, 9, 12, 15
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 18
- Organs examined: uterus, ovaries (including corpora lutea), cervix, vagina, peritoneal and thoracic cavities were examined grossly; maternal liver and kidneys were weighed and kidneys preserved for possible subsequent microscopic evaluation. - 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:
- Levene's test for equality of variances, analysis of variance (ANOVA) and t-tests. The latter were used when the F value from the ANOVA was significant. When Levene's test indicated equal variances, and the ANOVA was significant, a pooled t-test was used for pairwise comparisons. When Levene's test indicated heterogeneous variances, all groups were compared by an ANOVA for unequal variances followed, when necessary, by a separate variance t-test for pairwise comparisons. Nonparametric data were statistically evaluated using the Kruskal-Wallis test, followed by the Mann-Whitney U test when appropriate. Incidence data were compared using the Fisher's Exact test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Water consumption was increased in the 10.0 ml/kg bw/day groups during gestation days 6 to 9, 9 to 12, 12 to 15, for the combined treatment interval, gestation day 6 to 15, and subsequent to treatment from gestation days 15 to 18. In the 5.0 ml/kg bw/day group, water consumption was increased during treatment from 12 to 15 and subsequent to treatment from gestation days 15 to 18. In addition, though not statistically significant, water consumption values were increased in the middle dose group from gestation days 9 to 12 of treatment and for the combined treatment interval (gestation days 6 to 15) by 6-7% of control values.
No treatment-related clinical signs, effects on maternal body weights and body weight gains, food consumption were observed at any dose level. There were no treatment-related necropsy findings of the dams at the scheduled sacrifice on gestation day 18. There were no effects of treatment on terminal body weight, gravid uterine weight, corrected body weight, corrected weight change, or relative and absolute liver and kidney weight.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 400 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: No adverse effects except of increased water consumption
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no effects of treatment on the number of ovarian corpora lutea, on the number of total, viable or nonviable (early or late resorptions, and dead fetuses) implantations/litter or on sex ratio. There were no effects on fetal body weights/litter which were attributed to treatment. There were no differences in individual external, visceral or skeletal malformations by category, or in total malformations among all groups. There were no treatment related increases in the incidences of individual fetal external or visceral variations. Statistically significant increases in the incidences of fetal atelectasis and poorly ossified supraoccipital bone and an decrease in the incidence of extra ossification site in the nasal fontanel in the 0.5 ml/kg/day group were not considered to be treatment-related due to the lack of a dose-response relationship.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 400 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other:
- Remarks on result:
- other: No adverse effects on development at the highest dose tested. The NOAEL in mg/kg bw/day was calculated based on density of 1.04 g/ml for propylene glycol.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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