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EC number: 405-820-6 | CAS number: 30025-38-8
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1993-01-07 to 1193-05-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study - original study report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- Dipropylene Glycol Monoethyl Ether
- IUPAC Name:
- Dipropylene Glycol Monoethyl Ether
- Reference substance name:
- Propanol, (2-methoxy-methylethoxy)-
- IUPAC Name:
- Propanol, (2-methoxy-methylethoxy)-
- Reference substance name:
- -
- EC Number:
- 405-820-6
- EC Name:
- -
- Cas Number:
- 30025-38-8
- Molecular formula:
- C8H18O3
- IUPAC Name:
- reaction mass of 5-methyl-4,7-dioxa-2-nonanol and 6-methyl-4,7-dioxa-2-nonanol
- Details on test material:
- - Name of test material (as cited in study report): Dipropylene Glycol Monoethyl Ether
- Substance type: Glycol ether
- Physical state: Colourless liquid
- Analytical purity: 90.15%
- Lot/batch No.: EDP
- Storage condition of test material: Room temperature in opaque plastic container and brown glass bottle
- Other:
Constituent 1
Constituent 2
Constituent 3
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) Ltd, Manston, UK
- Age at study initiation: (P) 6-7 wks
- Weight at study initiation: (P) Males:183-186 g; Females: 148-151 g
- Housing:
- Diet : Pelleted rat and mouse diet ad libitum.
- Water : Tap water via bottle ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-75
- Air changes (per hr): >=15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1993-01-07 To: 1993-05-21
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Concentration in vehicle: Adjusted to achieve dosages of 0, 50, 225 or 1000 mg/kg in a 4 ml gavage dose
- Amount of vehicle (if gavage): 4 ml
Vehicle: Distilled water. - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: up to 21 days
- Proof of pregnancy: copulation plug and sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy
- After successful mating each pregnant female was caged individually and males returned to holding cage.
- Any other deviations from standard protocol: - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of test material formulation were taken weekly for analysis for achieved concentration using gas chromatography by an external standard technique.
- Duration of treatment / exposure:
- Parental animals treated for 74 days and during breeding; dams through gestation and lactation.
- Frequency of treatment:
- Once daily.
- Details on study schedule:
- - Age at mating of the mated animals in the study: [17-18] weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 225 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:
- 32
- Details on study design:
- - Dose selection rationale: Based on acute toxicity
- Positive control:
- No positive control
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Immediately before and 1 hour after dosing.
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly; days 1, 4, 7, 14, 21 post coitum and post partum
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption by cage, schedule as for body weight. - Oestrous cyclicity (parental animals):
- By vaginal smear following ejection of copulation plug.
- Sperm parameters (parental animals):
- Not studied
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring: clinical signs, number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, body weight and weight gain, physical or behavioural abnormalities, physical development (detachment of pinna, tooth eruption, eye-opening); reflexological assessment (surface righting, mid-air righting, startle and pupil).
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was determined for pups born or found dead. - Postmortem examinations (parental animals):
- DECEDENTS
Examine macroscopically internally and externally for abnormalities; abnormal tissues fixed for later study.
SACRIFICE
- Male and maternal animals: All surviving animals following successful weaning of offspring
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated below were prepared for microscopic examination and weighed (w), respectively.
Ovaries (w), uterus (w), cervix, vagina, testes (w), epididymides (w), seminal vesicles (w), prostate, coagulating gland, pituitary gland (w), kidneys (w) and significant abnormalities. - Postmortem examinations (offspring):
- SACRIFICE
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Statistics:
- Mating, pregnancy and parturition indices - Fisher Exact Probability Test.
Offspring viability Indices - Chi-squared analysis - Reproductive indices:
- Pre-coital interval
Mating index
Pregnancy index
Gestation length
Gestation and Parturition index - Offspring viability indices:
- Live Birth and Viability Indices (lactation data)
Sex ratio
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Up to half of animals in high dose group exhibited pre-dose salivation intermittently from week 5 until end of study. This observation is not regarded as adverse. No other treatment related observations.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Single death in high dose group attributed to mal-dosing. Three sacrifices made in mid and low dose group due to issues not related to treatment. One death also seen in control group.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Some statistical differences seen in the high dose group during weeks 4 and 6 was not attributed to treatment.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 and 225 mg/kg bw/day male rats showed a significant increase in the incidence and severity of basophilic renal tubules in the kidneys which is not unexpected and is not a reproductive effect.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effects on fertility, gestation or parturition. An apparent slight decrease in offspring viability in the high dose group was attributed to a larger group mean litter size at birth resulting in increased offspring deaths in the first four days, ie artefactual and not a genuine observation.
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: all other end points including reproductive toxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 225 mg/kg bw/day (actual dose received)
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Reflexological assessment
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
At 1000 mg/kg bw/day the only reactions of adults was pre-dose salivation which was intermittent and thought to be reflex response to test material that is either slightly irritant of 'foul' tasting. Also at the highest dosage there was an apparent decrease in offspring viability from birth to Day 4 post-partum due to larger group mean litter size at birth resulting in an increased number of deaths over the first 4 days of lactation. This was not considered an effect attributable to treatment. At 1000 and 225 mg/kg bw/day there was an increase in the incidence and severity of basophilic renal tubules of male rats only; this was not unexpected as a manifestation of known 'male rat hydrocarbon nephropathy' (Alden CL (1986). A review of unique male rat hydrocarbon nephropathy. Toxicologic Pathology Vol 14, No 1, pp 109 -111). This was not, however a reproductive toxicity.
At 50 mg/kg bw/day there were no significant treatment-related findings in either sex.
Summary of live birth and viability indices
Group |
Live birth index (%) |
Viability index % |
||||
1 |
2 |
3 |
4 |
5 |
||
1 |
96.7 |
06.8 |
99.1 |
99.3 |
100 |
95.2 |
2 |
95.3 |
98.8 |
99.0 |
100 |
100 |
97.6 |
3 |
96.6 |
97.7 |
99.5 |
98.7 |
100 |
95.9 |
4 |
91.5 |
96.0 |
99.1 |
99.1 |
100 |
94.3 |
Mean litter sizes during lactation
Group |
Mean # born |
Days post partum |
||||
1 |
4 |
7 |
14 |
21 |
||
1 |
15.8 |
15.2 |
14.8 |
14.6 |
14.5 |
14.5 |
2 |
15.4 |
14.7 |
14.5 |
14.3 |
14.3 |
14.3 |
3 |
15.1 |
14.6 |
14.2 |
14.1 |
14 |
14 |
4 |
16.7 |
15.3 |
14.7 |
14.6 |
14.5 |
14.5 |
Applicant's summary and conclusion
- Conclusions:
- The NOAEL (all reproductive measures) was 1000 mg/kg/day.
The NOAEL (male toxicity) was 50 mg/kg bw/day - Executive summary:
In a single generation OECD415 guideline study, Dipropylene Glycol Monoethyl Ether is not reprotoxic in the rat at dosages greater than those demonstrably toxic in male rats . The NOAEL (all reproductive measures) and in females was 1000 mg/g bw/day. The toxic NOAEL in males (only) was 50 mg/kg bw/day, a dosage that evokes male unique hydrocarbon nephropathy at a dose of 225mg/kg and above.
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