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EC number: 412-180-1 | CAS number: 10221-57-5 1,2-DIETHOXYPROPANE; DIETHOXY-1,2-PROPANE
- 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
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 August 1991 - 14 January 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline Chernoff/Kavlock preliminary screening developmental toxicity test
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:
- other: Chernoff/Kavlock preliminary screening developmental toxicity test
- Principles of method if other than guideline:
- Ten female Sprague-Dawley rats were dosed from DG6-16 orally (gavage) at doses of 0, 1000 and 1600 mg/kg bw/day DEP. The vehicle was distilled water with 2% Tween 80. The positive control was ethylene glycol diethyl ether. They were then monitored throughout gestation, parturition and until Day 4 of lactation, for clinical signs of toxicity, body weight and food consumption changes, signs at necropsy, duration of gestation and overall pup survival, litter and pup weights.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-diethoxypropane
- EC Number:
- 412-180-1
- EC Name:
- 1,2-diethoxypropane
- Cas Number:
- 10221-57-5
- Molecular formula:
- C7H16O2
- IUPAC Name:
- 1,2-diethoxypropane
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Synthetic Chemicals Limited, Four Ashes, West Midlands, England; 9059
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in the dark at ambient temperature
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley (Charles River CD strain; outbred albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, UK
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 280 g for males and ca 210 g for females
- Housing: Prior to mating, the females were housed 2 per cage in polypropylene cages measuring 42 x 27 x 20 cm, with stainless steel grid bottoms and mesh tops. A separate, stainless steel food hopper and a water bottle will be provided for each cage. The cages were suspended on racks, each containing 6 rows of 4 cages. On detection of mating, each female was re-housed in an individual solid bottomed cage of similar design. Sterilised white wood shavings were provided as bedding and white tissue paper was provided as nesting material. Males were housed singly in larger cages (58 x 38.5 x 20 em) of a similar design. The cages were suspended on racks, each containing 5 rows of 3 cages.
- Diet: Rat and Mouse Breeder Diet No.3 SQC Expanded, supplied bySpecial Diets Services Ltd, Stepfield, Witham, Essex, UK ad libitum (Appendix 1)
- Water: domestic mains water ad libitum (Appendix 2)
- Acclimation period: 4 days prior to pairing for mating.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 5O%± 15%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hrs
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water with 2% Tween 80
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The 2 materials (DEP and EGDE) were formulated as suspensions, the vehicle being distilled water containing 2% by volume of the surfactant Tween 80. Fresh suspensions were prepared daily, each concentration being prepared separately. The requisite quantity of vehicle was added to pre-weighed test material and mixed by inversion. The dosing suspensions were maintained in the animal room during dosing procedures using a magnetic stirrer.
- Details on mating procedure:
- Pairing was on the basis of 2 females to each male. For each female, cohabitation with a male was continuous until mating was detected. A vaginal lavage was examined each morning and the day of detection of sperm in the lavage, or of a copulatory plug in situ was considered to be Day 0 of gestation. A record was kept of the male which inseminated each female.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses for concentration, homogeneity and stability of dosing formulations were performed (Report No. 8246) prior to commencement of this study. Concentration and homogeneity were also analysed during this study. Triplicate 1 ml samples were taken from each test material and Control formulation on the first and eighth days of treatment. The results of the analyses conducted prior to this study, Report No. 8246, are presented in Appendix 3. These analyses demonstrated that adequately homogeneous formulations of both test materials could be prepared, and that those formulations were stable for 48 h when stored at 4 in the dark. The results of the analyses for concentration and homogeneity performed during this study are presented in Appendix 4. These results showed deviations from nominal concentration not exceeding 6%, indicating a satisfactory standard of accuracy in formulation.
- Duration of treatment / exposure:
- DG 6-16
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent vehicle
- other: Ethylene glycol diethyl ether (EGDE), a known developmental toxin.
- Details on study design:
- - Dose selection rationale: Doses were selected based on the results of the DRF study (Supporting, RL2, rat (DRF)/Shell, 1991/Toxicity to reproduction (Screening).001). Maternal toxicity was demonstrated at 1600 mg/kg bw/day DEP and at 1000 mg/kg bw/day EGDE, and to a lesser magnitude at 1000 mg/kg bw/day DEP.
- Positive control:
- Ethylene glycol diethyl ether (EGDE), a known developmental toxin was used. One group were allocated for EGDE administration. These animals were dosed once daily by gavage, with 1000 mg/kg bw/day from DG6-16.
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:All the animals were examined for reaction to treatment on each day. The nature, onset, duration and intensity of any signs were recorded. During the dosing period, the animals were. obServed at frequent intervals throughout the day, commencing approximately 5 min after dosing. In addition to the above, all the animals were checked for viability at the beginning of each day and again as late as possible on each day.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded on Days 0, 3, 6, 9, 13, 17 and 20 of gestation, and Days 1.and 4 of lactation (Day 0 of lactation = day of birth of the litter).
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes; The weight of food consumed by each mated female was recorded over the periods 0-3, 3-6, 6-9, 9-13, 13-17 and 17-20 of gestation. - Litter observations:
- Litters of pups were weighed en masse on Days 1 and 4 of lactation. The pups were counted and examined for the presence of milk in the stomach, and for any externally visible abnormalities daily until termination.
- Postmortem examinations (parental animals):
- The dams and their litters were killed between Day 4 and 9 of lactation. Animals which did not deliver a litter were killed after their (theoretical) 24th day of gestation.
Premature Decedents
Adult animals were necropsied with a view to diagnosis, from macroscopic findings, of the cause of the animal's condition or cause of death. An external examination was followed by inspection of the cranial, thoracic and abdominal cavities. The uterus was examined to determine the status of pregnancy.
Scheduled Termination
Animals which did not deliver a litter were killed after their (theoretical) 24th day of gestation, to determine the status of their pregnancies. Necropsy, for other animals completing the study timecourse, was restricted to a count of the number of implantation sites in the uterus. - Postmortem examinations (offspring):
- The dams and their litters were killed between Day 4 and 9 of lactation. Pups killed or found dead were discarded.
- Statistics:
- In evaluating and interpreting the data from this study it was not considered necessary to conduct any formal statistical analyses. Interpretation was based on inspection of the individual and group values.
- Reproductive indices:
- Gestation Index as %
Post implantation loss as % - Offspring viability indices:
- Birth Index
Live Birth Index
Viability Index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The majority of animals in the 1,2 DEP and EGDE treated groups demonstrated clinical signs of toxicity after dosing. These signs included subdued behaviour, ataxia, increased salivation, piloerection and red staining from the nose and on the face. For both test materials, the duration of the clinical signs varied between animals, with the onset being between approximately 5 and IS min after dosing, and lasting between approximately one and 6 h. The intensity of the clinical signs also varied between animals within the same dose group. The subdued behaviour and ataxia observed.in the EGDE treated group tended to be slightly more pronounced than in the 1,2 DEP treated groups
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- There were 2 premature decedents at 1000 mg/kg bw/day. Necropsy of these animals revealed findings indicative of aspiration of dosing formulation and/or accidental damage during the dosing procedure.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1600 mg/kg bw/day 1,2 DEP, there was a reduction in both mean body weight gain and food consumption over the treatment period, compared to the Negative Control. These effects were most pronounced over Days 6 to 9 of gestation, with a loss in body weight and a 32% reduction in food consumption over this period. At 1000 mg/kg bw/day DEP a similar pattern in body weight performance and food consumption to that seen at 1600 mg/kg bw/day 1,2 DEP was demonstrated. The magnitude of these effects however, was not as marked over Days 6 to 9 of gestation. A reduction in body weight performance and food consumption, comparable to that seen at 1000 mg/kg bw/day DEP, was demonstrated at 1000 mg/kg bw/day EGDE. The depression in body weight gain after Day 13 of gestation at 1000 mg/kg bw/day EGDE, was considered to have been a result of the resorbing litters. Body weight performance up to Day 4 of lactation at 1600 and 1000 mg/kg bw/day 1,2 DEP was similar to the Negative Control.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 1600 mg/kg bw/day 1,2 DEP, there was a reduction in both mean body weight gain and food consumption over the treatment period, compared to the Negative Control. These effects were most pronounced over Days 6 to 9 of gestation, with a loss in body weight and a 32% reduction in food consumption over this period. At 1000 mg/kg bw/day 1,2 DEP a similar pattern in body weight performance and food consumption to that seen at 1600 mg/kg bw/day 1,2 DEP was demonstrated. The magnitude of these effects however, was not as marked over Days 6 to 9 of gestation. A reduction in body weight performance and food consumption, comparable to that seen at 1000 mg/kg bw/day DEP, was demonstrated at 1000 mg/kg bw/day EGDE. The depression in body weight gain after Day 13 of gestation at 1000 mg/kg bw/day EGDE, was considered to have been a result of the resorbing litters. Body weight performance up to Day 4 of lactation at 1600 and 1000 mg/kg bw/day 1,2 DEP was similar to the Negative Control.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- At 1000 mg/kg bw/day EGDE, all 9 pregnant animals resorbed their litters. Duration of gestation, gestation indices and overall pup survival were considered to have been unaffected by treatment with 1,2 DEP.
Effect levels (P0)
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- clinical signs
- body weight and weight gain
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Occasional pups in all the groups with litters, showed minor changes (e.g. cold, bruised, agalactic) that are typical in these laboratories. No association with treatment was indicated
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- Overall pup survival were considered to have been unaffected by treatment with 1,2 DEP.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 1600 mg/kg bw/day 1,2 DEP, mean pup weight on Day 4 of lactation was slightly lower than the Negative Control. At 1000 mg/kg bw/day 1,2 DEP, mean pup weight was slightly reduced. This however, was a result of litter 19 which had a low mean pup weight and poor survival to Day 4 of lactation. Exclusion of this unrepresentative litter gave mean pup weight values which were similar to the Negative Control.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- In a Chernoff/Kavlock preliminary screening developmental toxicity test, maternal toxicity was demonstrated at the 2 doses tested (1600 and 1000 mg/kg bw/day DEP). Effects on the offspring of the 1,2 DEP treated animals were limited to a slight reduction in pup weight on Day 4 of lactation, at 1600 mg/kg bw/day.
- Executive summary:
In a non-guideline Chernoff/Kavlock preliminary screening developmental toxicity test (7721), 1,2-Diethoxypropane in distilled water with 2% Tween 80 was administered to 10 female Sprague-Dawley rats/dose by gavage at dose levels of 0, 1000 or 1600 mg/kg bw/day from days 6 through 16 of gestation. Ethylene glycol diethyl ether (EGDE), a known developmental toxin was used as a positive control (1000 mg/kg bw/day).
Maternal toxicity was demonstrated at 1600 and 1000 mg/kg bw/day 1,2 DEP and at 1000 mg/kg bw/day EGDE, by a reduction in body weight and food consumption, and by clinical signs of toxicity. The toxicity observed at 1000 mg/kg bw/day 1,2 DEP and at 1000 mg/kg bw/day EGDE was of a comparable magnitude. Marked embryotoxicity was demonstrated at 1000 mg/kg bw/day EGDE with the 9 pregnant animals resorbing their litters. At 1000 mg/kg bw/day 1,2 DEP, however, the offspring were considered to have been unaffected. Effects on the offspring of the 1,2 DEP treated animals were limited to a slight reduction in pup weight on Day 4 of lactation, at 1600 mg/kg bw/day 1,2 DEP.
The maternal LOAEL was 1000 mg/kg bw.day. The NOAEL (offspring) was 1000 mg/kg bw/day.
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