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EC number: 208-021-9 | CAS number: 505-84-0
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date: 5 April 2016, Experimental completion date: 20 May 2016.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX protocol no. 123.
- Deviations:
- yes
- Remarks:
- please see any other information on methods and materials section
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vitro
Test material
- Reference substance name:
- Dipropoxymethane
- EC Number:
- 208-021-9
- EC Name:
- Dipropoxymethane
- Cas Number:
- 505-84-0
- Molecular formula:
- C7H16O2
- IUPAC Name:
- 1-(propoxymethoxy)propane
Constituent 1
- Specific details on test material used for the study:
- Test substance: Propylal
Test substance identity (including alternative names): Dipropoxymethane
CAS number: 505-84-0
Intended use: solvent
Appearance: Colourless liquid
Storage conditions: Refrigerated (2-8°C), protected from light.
Batch number: 1602181700R
Expiry date: 18 February 2017
Purity: 99.6658%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Details on test animals or test system and environmental conditions:
- Animal supply, acclimatisation and allocation
Strain/Species Crl:CD(SD) rat.
Supplier Charles River (UK) Ltd.
Number of animals ordered 80 females.
Duration of acclimatisation At least 1week before commencement of pairing.
Age of the animals ordered Approximately 9 weeks old.
Mating
Male/female ratio 1:1 with identified stock males.
Daily checks for evidence of mating Ejected copulation plugs in cage tray and vaginal smear.
Day 0 of gestation When positive evidence of mating was detected.
Allocation and identification
Allocation On the day of positive evidence of mating (Day 0).
Identification of animals Each animal was assigned a number and identified uniquely within the study by a tail tattoo.
Environmental control
Rodent facility Full barrier - to minimise entry of external biological and chemical agents and to minimise the transference of such agents between rooms.
Air supply Filtered fresh air which was passed to atmosphere and not recirculated.
Temperature and relative humidity Monitored and maintained within the range of 19-23ºC and 40-70%, respectively.
There were no deviations from these ranges.
Lighting Artificial lighting, 12 hours light : 12 hours dark, with lights on at 01:00 GMT.
Window blinds remained open for the first three days allowing light ingress during the dark period. Blinds were closed prior to 13:00 GMT on 1st April 2016.
Electricity supply Public supply with automatic stand-by generators.
Animal accommodation
Cages Cages comprised of a polycarbonate body with a stainless steel mesh lid; changed at appropriate intervals.
Solid (polycarbonate) bottom cages were used during the acclimatisation and gestation periods.
Grid bottomed cages were used during pairing. These were suspended above absorbent paper which was changed daily during pairing.
Bedding (solid bottom cages) Wood based bedding which was changed at appropriate intervals each week.
Environmental enrichment
Aspen chew block Provided to each animal throughout the study and replaced when necessary.
Plastic shelter Provided to each cage throughout the study and replaced when necessary.
Diet supply
Diet SDS VRF1 Certified pelleted diet.
The diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
Availability Non-restricted.
Water supply
Supply Potable water from the public supply via polycarbonate bottles with sipper tubes. Bottles were changed at appropriate intervals.
Availability Non-restricted.
Administration / exposure
- Route of administration:
- other: Roller bottle culture technique
- Vehicle:
- corn oil
- Details on exposure:
- The roller bottle culture technique was used (New 1978). Embryos were cultured in the presence of each test substance for a period of approximately 48 hours at a temperature of 37.0 ± 1.0°C.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 48 hours
- Duration of test:
- 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: µg/mL
- Dose / conc.:
- 30 other: µg/mL
- Dose / conc.:
- 100 other: µg/mL
- Dose / conc.:
- 300 other: µg/mL
- Dose / conc.:
- 1 000 other: µg/mL
- No. of animals per sex per dose:
- 3 embryos per dose for preliminary study.
7 embryos per dose for main study - Control animals:
- yes, concurrent vehicle
- Details on study design:
- A preliminary test (0, 1, 10, 100 and 1000 µg/mL) was used to establish suitable treatment levels for the Main study. Propylal and Butylal showed little or no adverse effect on embryonic growth or development at dose levels up to 1000 μg/mL
Culture medium
The culture medium consisted of equal volumes of homologous rat serum, heat inactivated at 56.0 ± 0.5°C for 40 minutes, and HEPES-buffered Eagle’s minimum essential medium.
Maternal euthanasia
Dams were anaesthetised with a mixture of isofluorane and oxygen on the afternoon of the ninth day of gestation and, after removal of the uterus, were killed by exsanguination and/or cardiac section.
Embryo preparation
Decidua were subsequently released from the uterus and the embryos dissected out. The parietal yolk sac was torn open and removed. Only overtly healthy embryos with the visceral yolk sac and ectoplacental cone intact were cultured.
Culture methods
Embryos were incubated at 37.0 ± 1.0°C in 30 mL glass bottles which were rotated continuously at 60 rev/min throughout the period of culture. Each bottle contained up to five embryos with 1 mL of culture medium per embryo and a gas phase. The gas phase was 5% O2, 5% CO2 and 90% N2 for approximately 20 hours followed by 20% O2, 5% CO2 and 75% N2. Each bottle was identified by indelible marker pen showing group number, compound name and dose level. Cultures were terminated after approximately 48 hours.
Temperature was monitored continuously but recorded daily. Since these data show that there were no significant deviations from target values they are not presented.
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 other: μg/mL
- Based on:
- test mat.
- Basis for effect level:
- other: embryonic growth, development and morphology
Any other information on results incl. tables
Preliminary study
Embryos cultured in the presence of Propylal at doses up to 1000 μg/mL exhibited no adverse effect on embryonic growth, development or morphology. Findings at 1 μg/mL were not attributed to treatment.
Main Study
Embryos cultured in the presence ofPropylalat doses up to 1000 μg/mL exhibited no adverse effect on embryonic growth, developmentor morphology. Morphological observations were generally of a minor nature and were therefore considered incidental.
Discussion
Low incidences of minor morphological observations were recorded; these were mostly haemorrhages and common pericardial defects, which were considered unlikely to be related to treatment.
For preliminary study cultures started on 19 April 2016, stoppers had fallen out of four bottles prior to the start of culture. The medium within these bottles appeared bright pink. Since there was insufficient time to prepare fresh medium these bottles were assigned to the lowest concentration level for material dosed on that day. Effects seen could be attributed to the change in the culture medium as they were not seen at the higher dose levels; hence for propylal, findings at 1 μg/mL were not attributed to treatment
No other effects were seen following treatment with propylal, hence this material was considered not to show developmental toxicity in vitro.
Applicant's summary and conclusion
- Conclusions:
- It was observed from this exploratory investigation that embryos cultured in the presence of propylal exhibited no adverse effects on growth, development or morphology. It was concluded, therefore, that propylal showed no potential embryo toxicity or teratogenicity.
- Executive summary:
Summary
The influence of Propylal, upon growth and development in vitro was assessed in Day 9.5 embryos from rats of the CD strain. Each test substance was added to the culture medium at concentrations of 1, 10, 100 and 1000 mg/mL in groups of 3 embryos in the preliminary study. In the main study groups of 7 embryos were administered each test substance at concentration levels of 30, 100, 300 and 1000mg/mL. The negative Control group received the vehicle corn oil at the same volume-dose. All embryos were evaluated after approximately 48 hours in culture.
Results
Propylal: No adverse effect on embryonic growth, development or morphology was observed at doses up to 1000 μg/mL.
Conclusion
It was observed from this exploratory investigation that embryos cultured in the presence of propylal exhibited no adverse effects on growth, development or morphology. It was concluded, therefore, that propylal showed no potential embryo toxicity or teratogenicity.
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