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EC number: 406-880-6 | CAS number: 88917-22-0 ACETATE DPMA ACROSOLV; ACROSOLV DPMA ACETAT; ACROSOLV DPMA ACETATE; DOWANOL DPMA; DOWANOL DPMA GLYCOL ETHER; DOWANOL DPMA GLYKOL ETHER; ETHER DE GLYCOL DPMA DOWANOL
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to EPA TG 798.4900 and in accordance with GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): dipropylene glycol methyl ether (DPM) as surrogate for dipropylene glycol methyl ether acetate (DPMA)
- Molecular formula (if other than submission substance): C7H16O3
- Molecular weight (if other than submission substance): 148.2
- Analytical purity: 100%
- Impurities (identity and concentrations): No impurities at a level equal to or above 0.1% were identified in the test material
- Composition of test material, percentage of components: 100% DPGME
- Lot/batch No.: 881220
- Stability under test conditions:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Duchland
- Weight at study initiation: 3.5-4.5 kg
- Housing: individual
- Diet (e.g. ad libitum): 4oz/day - 8 oz/day, except during exposure
- Water (e.g. ad libitum): ad libitum
- Acclimation period: three weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard conditions
- Humidity (%): standard conditions
- Air changes (per hr): standard conditions
- Photoperiod (hrs dark / hrs light): standard conditions
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 4 cubic meter stainless steel and glass Rochester-type inhalation chambers (1.6 meter cube with a pyramidal top)
- Source and rate of air: compressed air
- Temperature, humidity, pressure in air chamber: 22°C, 50% RH
- Air flow rate: 800 l/min
- Vapors of test material were generated by metering the test material into a glass J-tube or modified distillation column. Compressed air was passed through the J-tube/distillation column simultaneously to vaporize the test material. The air was heated with a heat gun to help vaporize the test material.
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of the test material was determined approximately 10 times/exposure period by infrared spectroscopy. The analytical equipment was calibrated with vapor standards of known concentrations and was checked prior to each exposure with at least one standard. The nominal concentration (ratio of test material used to the total chamber airflow through the chamber) was calculated daily for each chamber.
- Samples taken from breathing zone: Four points were compared to the primary sampling line (reference line) in each chamber in which DPGME was introduced. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The average concentration of DPGME relative to the reference line in the 50, 150 and 300 ppm exposure chambers were 98 ± 5%, 101 ± 3% and 106 ± 1%, respectively for the pretest determination and 93 ± 3%, 100 ± 1% and 110 ± 2%, respectively, for the test period.
The average analytical concentration of DPGME vapors present in the chambers during exposures were 0, 51, 152 and 282 ppm for the control, 50, 150 and 300 ppm exposure chambers, respectively. - Details on mating procedure:
- - Impregnation procedure: [artificial insemination]
- Proof of pregnancy: [day of insemination] referred to as [day 0] of pregnancy - Duration of treatment / exposure:
- days 7-19 of gestation
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- 28 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
50 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
150 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
300 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 16 inseminated rabbits/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a teratology probe study
- Rationale for animal assignment (if not random): random
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 7, 10, 13, 16, 20 and 28 of gestation
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 28
- Organs examined: maternal liver and uterine contents
- Any animal which died or demonstrated indications of early termination of preganancy was subjected to a complete necropsy examination.
OTHER: CLINICAL CHEMISTRY: Yes
- ALP, ALT, AST, CK, UN, creatinine, TP, albumin, globulin, glucose, cholesterol, triglycerides, total bilirubin and electrolytes (Na, K, P, Cl, Ca) were conducted with CentriChem automated chemistry analyser and Beckman E4A - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [all per litter] - Statistics:
- Maternal body weights, weight gain, absolute and relative organ weights and fetal body weights - Bartlett's test for equality of variances, ANOVA, Dunnett's or Wilcoxon Rank-Sum Test with Bonferroni's correction
Pre-implantation loss, resorptions and fetal alterations among litters and fetal population - censored Wilcoxon Test with Bonferroni's correction
Number of corpora lutea and implants, litter size - ANOVA followed by Wilcoxon Rank-Sum Test with Bonferroni's correction
Pregnancy rate - Fisher exact probability test
Sex ratio - binomial distribution test - Indices:
- Pre-implantation loss, implantations resorbed and litter with resorptions
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- >= 300 ppm (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- >= 300 ppm
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In conclusion, inhalation exposure of pregnant rabbits to concentrations of DPGME as high as 300 ppm (highest concentration of DPGME practically attainable at normal room temperature and pressure) on days 7 through day 19 of gestation was not maternally toxic, embryo/fetotoxic or teratologic.
- Executive summary:
Groups of 16 inseminated New Zealand White rabbits were exposed via inhalation for 6 hours/day to 0 (control, filtered air), 50, 150 and 300 ppm of DPGME vapors on days 7 through 19 of gestation. In-life parameters included clinical observations and body weight. On day 28 of gestation, all animals were euthanatized prior to cesarean section. Maternal liver and gravid uterine weights, number of corpora lutea, implantations, resorptions and live/dead fetuses were recorded at cesarean section. All fetuses were then removed from the uterus, weighed and examined for external, visceral and skeletal alterations. No treatment related effects were observed on any of the maternal or embyonal/fetal parameters evaluated at any exposure level.
In conclusion, inhalation exposure of pregnant rabbits to concentrations of DPGME as high as 300 ppm (highest concentration of DPGME practically attainable at normal room temperature and pressure) on days 7 through day 19 of gestation was not maternally toxic, embryo/fetotoxic or teratologic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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