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EC number: 207-997-3 | CAS number: 504-63-2
- 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
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:
- guideline study
- Remarks:
- ACC PDO panel assigned reliability of 1. PDO from chemical process.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Propane-1,3-diol
- EC Number:
- 207-997-3
- EC Name:
- Propane-1,3-diol
- Cas Number:
- 504-63-2
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propane-1,3-diol
- Details on test material:
- 1,3-Propanediol, Polymer Grade (CAS 504-63-2) - abbreviated to '1,3-Propanediol' in this report.
Physical State: Liquid, colourless, odourless.
Storage Conditions: In a closed container.
Stability: Stable until June 1997.
Purity: 99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hag: SD Breeder: Lippische Versuchstierzucht; HAGEMANN GmbH; D-4923 Extertal 1
- Age at study initiation: Approximately 56 days
- Weight at study initiation: 193-242 grams
- Fasting period before study: No
- Housing: Single MAKROLON cages type III (cleaned/changed once a week).
- Diet (e.g. ad libitum): ALTROMIN 1314 ad libitum
- Water (e.g. ad libitum): Tap (in bottles) ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 50±15%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropyl-methylcellulose gel
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of approx. 10 ml were taken for each dose group immediately after preparation of the test suspensions as well as 8 and 24 hours after storage at room temperature (3 samples/dose-level). These samples were needed for determination of the concentration.
- Details on mating procedure:
- - Impregnation procedure: Co-housed.
- Proof of pregnancy: Sperm in vaginal smear referred to as day 0 of pregnancy.
- M/F ratio per cage: 1/1
Fertile ('proved') 4-12 month old male rats of the same breed served as partners. They were repeatedly employed, at the earliest three days after successful copulation. The female breeding partners were randomly chosen. Matings were monogamous. - Duration of treatment / exposure:
- Treatment from day 6 to 15 of gestation.
- Frequency of treatment:
- Daily.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 (all female).
- Control animals:
- yes
- Details on study design:
- - Rationale for animal assignment (if not random): The rats were assigned to their respective group according to their mating day i.e. in a cyclic way following the listing of positive findings in the vaginal smear.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice/day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice/day
BODY WEIGHT: Yes
- Time schedule for examinations: Daily (morning)
FOOD CONSUMPTION: Yes
- Determined daily by weighing residue.
WATER CONSUMPTION: Yes
- Time schedule for examinations: Visually inspected daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: ovaries, uteri, other internal organs. - 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 and size resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- Fetal exams included:
-Count.
-Sex, viability.
-Weight, length.
-External exams for damages/malformations.
-Dissected and the number and type of possible variations (inc. retardations) or malformations was determined macroscopically.
-Location, size, and condition of the internal organs were determined.
-Skeletal system.
-Variations examined according to WILSON. - Statistics:
- After randomisation of the animals an analysis of variance was carried out.
-Homogeneity of variances (Bartlett chi-square).
-If variances are homogeneous (one way analysis of variance was applied).
-When results indicated significant difference (DUNNETT test).
-Heterogeneity of variances (Student's t-test).
-Comparison of malformation, resorption, retardation and variation rates (Exact test of R.A. FISHER's or chi square test).
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights remained within the normal range at 250 and 1000 mg/kg. Body weight gain showed no distinct influence of the test compound at 250 mg/kg. Body weight gain was slightly (-32%) but not significantly inhibited between gestation days 6 and 9 in the 1000 mg/kg group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Gross pathological findings:
- no effects observed
- Details on results:
- The fertility rate was 90.9% for all three groups.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: no adverse effects noted at highest dose level tested
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Description (incidence and severity):
- In the control, one fetus had shortened hindlimbs and missing toes on the right foot.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- The fetal incidence of all retardations was slightly and significantly increased at the skeletal examination for the 1000 mg/kg, particularly for the skull (retarded ossification). However, the significance observed was due to the low incidence of retarded skull ossification found in the control group in this study which was much below the background incidence. The incidence found for the dose level groups were within the range of the background hence no biological significance was attached to the finding.
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: no adverse effects noted at highest dose level tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Mean
Maternal Body Weight Gain (g)
Gestation Test
Group (mg/kg bw)
Days 0 250 1000
===================================
0-3 12.4 11.0 11.6
3-6 13.8 14.6 13.2
6-9 11.1 9.2 7.5
9-12 14.5 15.4 15.3
12-15 15.9 14.8 15.9
15-18 35.1 36.2 31.9
18-20 27.9 30.5 31.0
====================================
Fetal
Skeletal Retardations
Test
Group (mg/kg bw)
Parameter 0 250 1000
====================================
Total
Retardations
Fetal
Incidence (%) 63.9 63.5 77.4*
Litter
Incidence (%) 90.0 95.0 100.0
Incomplete
ossification of
the skull
Fetal
Incidence (%) 26.9 41.3* 41.9**
Litter
Incidence (%) 75.0 85.0 80.0
===================================
* p =< 0.05
** p =< 0.01
Applicant's summary and conclusion
- Conclusions:
- 1,3-Propanediol did not possess teratogenic properties.
- Executive summary:
1,3 -Propanediol was administered to pregnant rats at concentrations of 0, 250, or 1000 mg/kg by oral gavage on gestation days 6-15. Maternal toxicity was evaluated via clinical observations, body weight, and food consumption. On gestation day 20, the surviving rats were laparotomized under ether narcosis. The ovaries and uterus were removed and a macroscopic examination of the internal organs was conducted. The number and size of resorptions were determined. The corpora lutea in the ovaries, implantations and location of the fetuses in the uterus were recorded. The gravid uterus weight and the weight of the placentae was recorded. The fetuses were removed from the uterus and were counted, sexed, assessed for viability, weighed and length measured, examined externally for malformations and dissected and examined for macroscopic malformations. In 50% of the fetuses/litter, the thoracic and peritoneal cavities were opened and the location, size and condition of the internal organs were determined. The skeletons were stained with Alizarin and the skeletal system was evaluated according to. Retardations, variations and/or malformations were examined and the number of occurrences recorded. In the remaining 50% of fetuses/litter, body sections were prepared and examined for variations according to.
No substance related mortality or clinical signs were observed in the dams. Body weights remained within the normal range at 250 and 1000 mg/kg. Body weight gain showed no distinct influence of the test compound at 250 mg/kg. Body weight gain was slightly (-32%) but not significantly inhibited between gestation days 6 and 9 in the 1000 mg/kg group. Treatment did not influence drinking water or food consumption. No substance-related pathological changes were detected at autopsy. No distinct influence on the prenatal development was detected. All fetal parameters were within the normal range of the control group. No substance-related variations and/or retardations were found. No malformed fetuses were detected in the substance-treated groups. No dead fetuses occurred in the substance treated and control dams. Therefore, the maternal and fetal NOAELs were determined to be 1000 mg/kg.
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