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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69/EEC Part B: Methods for the Determination of Toxicity, B.12. Micronucleus Test
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
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:
- - Name of test material (as cited in study report): 1,3-propanediol, trimethylene glycol
- Physical state: Clear, colourless liquid.
- Analytical purity: >= 99.8%
- Stability under test conditions: The stability of the test substance under the given storage conditions was guaranteed by the sponsor throughout the experimental period.
- Storage condition of test material: Tightly closed container under nitrogen at room temperature.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Hsd/Win: NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: males: 30-36 g; females: 25-30 g
- Assigned to test groups randomly: yes (computer generated random numbers)
- Fasting period before study: 16 hours before treatment.
- Housing: Macrolon cages, type II, 1 animal per cage.
- Diet: ad libitum
- Water:ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-21.5°C
- Humidity (%): 50-58%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: The test material was freshly diluted with aqua ad iniectabilia (Ampuwa, batch No. EL 1009, supplied by Fresenius AG, D-61343 Bad Homburg v d Hohe)
- Administration volume: 10.0 mL/kg b.w. - Frequency of treatment:
- single administration
- Post exposure period:
- 24 and 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 470 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 150 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Main test: 28 (14 males and 14 females) at 2150 mg/kg bw
Repetition Test: 12 (6 males and 6 females) each at 1000, 1470 and 2150 mg/kg bw - Control animals:
- other: Main Test: Physiological saline solution; 12 males + 12 females. Repetition Test: 6 males + 6 females.
- Positive control(s):
- Main Test positive control: cyclophosphamide (31.6 mg/kg bw) in physiological saline solution; 6 males + 6 females.
Repeat Test positive control: cyclophosphamide (31.6 mg/kg bw) in physiological saline solution; 6 males + 6 females.
Examinations
- Tissues and cell types examined:
- clinical observation; bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Range finding study identified that 4640 mg/kg bw caused severe toxicity symptoms and death, and at 3160 mg/kg bw distinct toxicity symptoms but no death was observed. Test guideline considers 2000 mg/kg bw to be the maximum single (limit) dose to be administered.
DETAILS OF SLIDE PREPARATION: Mice were sacrificed by CO2 overdose. Both femurs removed from each mouse and the bone marrow cells flushed into a labeled centrifuge tube with approx. 1.5 mL of fetal calf serum. Centrifuged at approx. 180 x g for 5 minutes. Supernatant serum was discarded and bone marrow cells suspended upon a thin layer of serum. A small drop of the marrow serum suspension was smeared on a slide and allowed to dry overnight.
METHOD OF ANALYSIS: Microscopical evaluation; 1000 polychromatic erythrocytes per animal were scored for the incidence of polychromatic erythrocytes with micronuclei. Calculation of PCE/NCE, based on 1000 erythrocytes (PCE+NCE) scored per slide.
- Evaluation criteria:
- If a test material produced neither a statistically significant and reproducible positive response nor a dose related statistically significant response at any one of the test points compared to the negative control group, it is considered non-mutagenic in this system.
- Statistics:
- POISSON test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- non-mutagenic
- Toxicity:
- no effects
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Under the experimental conditions reported, 1,3-Propanediol is considered not to induce chromosomal mutations in mice by damage to the chromosomes or the miotic apparatus at 24 or 48 hour intervals after the animals had received a single oral dose of 2150 mg/kg body weight. However, a weak clastogenic effect cannot be totally excluded due to a statistically significant increase in micronucleated polychromatic erythrocytes at the 48 hour sampling time when calculations were performed for males and females combined. According to the test guideline, a second test (repetition test) was performed to examine the reproducibility of the statistically significant response at the 48 hour sampling time in males and females combined and to assess a possible dose relation in the increase of micronucleated polychromatic erythrocytes. These responses could not be verified during the repetition test using two additional dose levels and is therefore considered to be an incidental finding.
Therefore, 1,3-Propanediol is non-mutagenic in the reported in vivo mouse micronucleus test.
Any other information on results incl. tables
|
Mean PCEs with MN (Males) |
Mean PCEs with MN (Females) |
||
Main Test |
24-Hours |
48-Hours |
24-Hours |
48-Hours |
Negative Control |
1.4 |
1.2 |
1.4 |
1.1 |
2150 mg/kg |
1.0 |
2.2 |
1.8 |
1.5 |
Positive Control |
13.8 |
|
14.7 |
|
Repetition Test |
|
|
|
|
Negative Control |
|
2.0 |
|
2.0 |
1000 mg/kg |
|
0.8 |
|
1.4 |
1470 mg/kg |
|
1.0 |
|
1.0 |
2150 mg/kg |
|
2.0 |
|
1.2 |
Positive Control |
|
6.6 |
|
6.3 |
Applicant's summary and conclusion
- Conclusions:
- 1,3-Propanediol is non-mutagenic in the reported in vivo mouse micronucleus test.
- Executive summary:
This in vivo micronucleus test in mice was performed to assess the potential mutagenic activity, induced by 1,3-propanediol through damage to the chromosomes of to the mitotic apparatus. The main test was performed with three groups, the negative control, the positive control, and the test material group (2150 mg/kg). Half the mice were sacrificed at 24 hours after treatment and the remaining mice were sacrificed 48 hours after treatment. Bone marrow was removed from the femurs for examination. All animals of the positive control group were sacrificed 24 hours after administration. One thousand polychromatic erythrocytes (PCE) per animal were scored for micronuclei. The ratio of polychromatic to normochromatic erythrocytes (NCE) was used to assess the toxicity of the test material. No test substance-related clinical observations were observed in the mice. No mortality was observed. Under the experimental conditions reported, 1,3-Propanediol is considered not to induce chromosomal mutations in mice by damage to the chromosomes or the miotic apparatus at 24 or 48 hour intervals after the animals had received a single oral dose of 2150 mg/kg body weight. However, a weak clastogenic effect cannot be totally excluded due to a statistically significant increase in micronucleated polychromatic erythrocytes at the 48 hour sampling time when calculations were performed for males and females combined.
According to the test guideline, a second test (repetition test) was performed to examine the reproducibility of the statistically significant response at the 48 hour sampling time in males and females combined and to assess a possible dose relation in the increase of micronucleated polychromatic erythrocytes. Dose levels of 1000, 1470, and 2150 were used in the repetition test. The responses of the first test could not be verified during the repetition test using two additional dose levels and is therefore considered to be an incidental finding. Therefore, 1,3-Propanediol is non-mutagenic in the reported in vivo mouse micronucleus test.
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