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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 February 1992 - 11 November 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- 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, PO Box 8, Common lane, Knottingley, West Yorkshire, WF11 8BW; 370101
- Purity: 99.54%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at ambient temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 4 weeks
- Weight at study initiation: 60 g (female); 85 g (male)
- Housing: Rats were housed 2 or one per cage by sex and dose group in suspended polypropylene cages (overall dimensions ca 420 x 270 x 200 mm) with stainless steel wire grid tops and bottoms. Beneath each cage was suspended a polypropylene tray containing absorbent paper. Tray paper was changed twice each week during the study. Each cage had a polypropylene water bottle (total capacity 300 ml) with rubber washer and melamine cap. Water bottles were changed once each week during the course of the study
- Diet (e.g. ad libitum): SQC Expanded Rat and Mouse No. 1 Maintenance Diet, supplied by Special Diets Services Limited, Stepfield, Witham, Essex, CMB 3AD ad libitum.
- Water: tap water ad libitum
- Acclimation period: 9 days
DETAILS OF FOOD AND WATER QUALITY: Analysis of the batch of diet used for the majority of the study and analysis of water sampled during the course of the study are presented in Appendices 2 and 3.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%):50% ± 15%
- Air changes (per hr): 15-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing the surfactant Tween 80 (2%)
- Details on oral exposure:
- - PREPARATION OF DOSING SOLUTIONS:
DEP was administered once each day for 28 consecutive days orally via a steel cannula at a constant dose volume of 10 ml dosing suspension/kg of bodyweight. To achieve this animals were weighed each day and this weight used to derive the correct volume of dosing suspension to be administered. Control rats received the vehicle at the same dose volume.
Dosing suspensions of 1 (low), 10 (Intermediate) and 100 (High) mg/ml were prepared fresh daily be serial dilution of the highest concentration. The highest concentration of dosing suspension was prepared by direct admixture, using distilled water containing the surfactant Tween 80 (2%) as vehicle. Dosing suspensions for Control animals were also prepared fresh daily, using distilled water containing Tween 80.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses of dosing suspensions were undertaken on samples prepared during the first and fourth weeks of dosing, a summary of results is included in Appendix 5. Analyses of dosing suspensions prepared for one day during Weeks 1 and 4 of dosing showed all values to be acceptable for accuracy of preparation (-7.6% to -2.1%).
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses for the study were selected based on the results of the 7 day DRF study (Supporting, RL2, rat (DRF)/Shell, 1992/Repeated dose toxicity: oral.001).
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All animals were examined for reaction to treatment during each day. The onset, intensity and duration of these signs were recorded.
All animals received a detailed clinical examination once each week, including appearance, movement, and behaviour patterns, skin and hair condition, eyes and mucous membranes, respiration and excreta.
BODY WEIGHT: Yes
- Time schedule for examinations: The weight of each animal was recorded twice each week commencing one week before the start of treatment up until the end of the study.
FOOD CONSUMPTION AND COMPOUND INTAKE:
The quantity of food consumed by each cage of animals was recorded twice each week, commencing one week before the start of treatment up until the end of the study.
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: Water consumption was monitored by visual inspection on a weekly basis throughout the study.
HAEMATOLOGY: Yes
Samples were taken from all rats from each group during Week 4 of dosing without overnight deprivation of food. Blood samples were collected from the orbital sinus under light ether anaesthesia except for the Hepato Quick test (a measure of clotting time) which was sampled by tailsnip without anaesthesia. Haematology parameters were measured on 0.5 ml of whole blood taken into tubes containing EDTA.
CLINICAL CHEMISTRY: Yes
Samples were taken from all rats from each group during Week 4 of dosing without overnight deprivation of food. Blood samples were collected from the orbital sinus under light ether anaesthesia except for the Hepato Quick test (a measure of clotting time) which was sampled by tailsnip without anaesthesia. Clinical chemistry parameters were measured on plasma from 1.5 ml of whole blood taken into tubes containing heparin. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Weights and histology: Liver, Heart, Kidney, Spleen, Adrenals, Testes & epididymides. The tissues examined histologically were from all animals in the Control and High dose groups.
Fixed: Liver, Heart, Kidney, Spleen, Adrenals, Testes, Ovaries, Abnormal Tissue. - Statistics:
- Haematology, clinical chemistry, organ weight and body weight data were statistically analysed for homogeneity of variance using the 'F-max' test. If the group variances appeared homogeneous a parametric ANOVA was used and pairwise comparisons made via Student's t-test using Fisher's F-protected LSD. If the variances were heterogeneous log or square root transformations were used in an attempt to stabilise the variances. If the variances remained heterogeneous, then a non-parametric test such as Kruskal-Wallis ANOVA was used.
Organ weights were also analysed conditional on body weight (i.e. analysis of covariance).
Histology data were analysed by Fisher's Exact Probability test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Notable clinical signs (piloerection and sleepy and/or subdued behaviour) were seen in 5/5 High dose males and 5/5 High dose females from Day 1 to Day 9 of the study. These signs were evident post dose and generally lasted for only part of the day. Clinical signs (piloerection and subdued behaviour) were also seen in 4/5 Intermediate dose females on Day 3 only. These signs were graded as mild and as with those seen in the High dose group were evident post dose for only part of the day.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no premature deaths.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males: The Low dose group showed a slight (12%) reduction in body weight gain. Due to the lack of effect in the Intermediate or High dose groups this reduction is considered to be due to chance.
Females: There were no notable intergroup differences. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no notable intergroup differences.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- Visual assessment of water bottles revealed no notable intergroup differences.
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In males, there were no notable intergroup differences. In females, Hepato Quick (pro-thrombin time) was slightly increased in the Low (10%, P<0.05) and Intermediate (14%, P<0.01) dose groups. Due to the lack of effect in the High dose group, these changes are considered to be due to chance.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In males, there were no notable intergroup differences. In females, ALT was reduced in the Intermediate dose group (18%, P<0.01). Due to the lack of effect in the High dose group this reduction is considered to be due to chance.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- In males, liver and kidney weight were increased in the High dose group after covariance analysis (18%, P<0.01 and 10%, P<0.01) respectively). Kidney weight was also slightly decreased in the Intermediate dose group after covariance analysis (6%, P
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no notable findings.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Centrilobular hepatocyte hypertrophy, graded as very mild was seen in 5/5 High dose males and 2/5 Control males. This finding was not seen in any females.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a 28 day repeated dose toxicity study in rats, the NOAEL (male/female) was 100 mg/kg bw/day based on changes in the liver.
- Executive summary:
In a sub-acute toxicity study (7804), 1,2-Diethoxypropane (99.54%) was administered by gavage to Sprague-Dawley rats (5/sex/group) in distilled water with 2% Tween 80 at 0, 10, 100 or 1000 mg/kg bw/day for 28 days.
Analyses of dosing suspensions prepared for one day during Weeks 1 and 4 of dosing showed all values to be acceptable for accuracy of preparation (-7.6% to -2.1% difference from nominal concentrations).
There were no premature deaths. Clinical reaction to treatment which included piloerection and sleepy and/or subdued behaviour was seen in High dose males and females post dose from Day I to Day 9 of the study. Piloerection and subdued behaviour were also noted in Intermediate dose females post dose on one day only. Since the reactions recorded in this 'group were graded as mild and were evident for only a short period of time they are not considered to be of toxicological significance and their reproducibility is doubtful. There were no notable intergroup differences in either sex in body weights, food consumption, haematological or clinical chemistry parameters. A slight, equivocal increase in kidney weight was seen in High dose males and females; there were no related histological changes. Centrilobular hepatocyte hypertrophy in the liver was increased in incidence but not severity in High dose males, this change may relate to the slight, equivocal increase in liver weight seen in High dose males and females. Since the centrilobular hepatocyte hypertrophy was graded as very mild and seen in males only its reproducibility is considered to be doubtful.
The changes noted in the male livers are more than likely adaptive but as the dosing interval was 10-fold, a NOAEL of 100 mg/kg bw/day was selected, as a conservative approach.
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