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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
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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD guideline 407.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, Published in the official journal of E.C.(No. L25I, 19 September 1984)
- 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
- Details on test material:
- - Name of test material (as cited in study report): T-4388
- Physical state: Colorless Liquid
- Lot/batch No.: ( 6 )
- Storage condition of test material: In the dark at ambient temperature.
Constituent 1
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 )
- Age at study initiation: 5-6 week
- Weight at study initiation: Male -144-150 gms and Female - 107 - 111 gms
- Housing: Rats were housed 2 or 3 of one sex per cage in suspended polypropylene cages with stainless steel wire grid tops and bottoms
- Diet ( ad libitum): SQC Expanded rat and mouse maintenance diet No. 1 supplied by special diet services limited,Stepfield, Witham, Essex, CM8 3 AB.
- Water ( ad libitum):Tap water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C - 22 °C
- Humidity (%): 45 - 65 %
- Air changes (per hr): 15-20
- Photoperiod : (12hrs dark / 12hrs light)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing solutions were prepared daily using distilled water as vehicle.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- See the attachment - 2
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg
Basis:
other: nominal concentration
- Remarks:
- Doses / Concentrations:
250 mg/kg
Basis:
other: nominal concentration
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
other: nominal concentration
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Dose levels were selected for this is on the basis of preliminary one week oral range finding study , conducted by Inveresk Research International.
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- -CAGE SIDE OBSERVATIONS: No
-DETAILED CLINICAL OBSERVATIONS: Yes, Weekly
-BODY WEIGHT: Yes
-Water Consumption : Yes, Weekly
-Time schedule for examinations: Weekly
-FOOD EFFICIENCY: Not Examined
-OPHTHALMOSCOPIC EXAMINATION: No
-HAEMATOLOGY: Yes
- Time schedule for collection of blood: During 4th week of dosing
- Anaesthetic used for blood collection: Yes ( Light Ether Anaesthesia )
- Animals fasted: Yes
- How many animals: 40
- Parameters checked : Hb, RBC, HCT, MCH, MCV, MCHC, WBC, DLC
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:During 4th week of dosing
- Animals fasted: Yes
- How many animals: 40
- Parameters checked : BUN, Glu, AST, ALT, AP,Na, K, Cl, TP, Alb, AG-R, Crea, Ca, Phos, T. Bl.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- none
- Statistics:
- Hematology, 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 homogenous a parametric ANOVA was used and pairwise comparisons made via student’s T test using Fischer’s F- protected LSD. If the variances were heterogeneous log or square root transformations were used in an attempt to stabilize the variances. If variances remained heterogeneous then a non parametric test such as Kruskal- Wallis ANOVA was used.
Organ weights were also analysed conditional on body weight. Histological data were analysed by Fisher’s Exact Probability test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY : Increased breathing and subdued behavior were evident in the majority of animals of both sexes receiving T-4388. There were no deaths found during 4 weeks of dosing period.
BODY WEIGHT AND WEIGHT GAIN : There were no notable intergroup differences in either sex during 4 weeks of oral administration of T-4388.
FOOD CONSUMPTION :There were no notable intergroup differences in either sex during 4 weeks of oral administration of T-4388.
FOOD EFFICIENCY : Not examined
HAEMATOLOGY :There were no notable intergroup differences in either sex .
CLINICAL CHEMISTRY : There were no notable intergroup differences in either sex .
ORGAN WEIGHTS : There was a slight increase in liver in high dose females.
GROSS PATHOLOGY : There were no notable intergroup differences in either sex .
HISTOPATHOLOGY: NON-NEOPLASTIC : There were no findings considered to be due to administration of the test material.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Slight increase in liver weight of females not accompanied by histopathological changes.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study a dose of 1000 mg/kg/day was identified as no observed adverse effect level. Based on a slight increase in liver weight which was not accompanied by histopathologic changes and observed in females only. The no observed effect level is 250 mg/kg/day.
dosing Sprague-Dawley rats with dose levels of 100, 250, 1000 mg/kg/day T-4388 produced increased breathing and subdued behavior in the majority of animals of both sexes receiving T-4388 and a slight increase in liver weight at 1000 mg/kg/day in females
Only. - Executive summary:
Four groups of Sprague- Dawley rats each containing 5 males and 5 females received T- 4388 (colorless liquid) via oral route by steel cannula at dose levels of 0,100, 250, 1000 mg/kg/day daily for 28 days. Rats were received from Charles River (UK) and housed 2 or 3 of one sex per cage in suspended polypropylene cages with stainless steel wire grid tops and bottoms. Animals were kept for acclimatization for 8 days and provided adlibitum feed and water. Temperature maintained in animal rooms was 18 °C - 22 °C with relative humidity of 45 - 65 % and 15-20 air changes.12 hour dark and 12 hour light photoperiod was maintained.
All animals were monitored for toxic effects which included clinical observations, body weights, organ weights, hematology, clinical chemistry, macroscopic and microscopic evaluations. Increased breathing and subdued behavior were evident in the majority of animals of both sexes receiving T-4388. There were no deaths found during 4 weeks of dosing period.
In body weights and feed consumption, there were no notable intergroup differences in either sex during 4 weeks of oral administration of T-4388. In hematology and clinical chemistry, there were no notable intergroup differences in either sex. In organ weights there was a slight increase in liver in high dose females.
There were no notable intergroup differences in either sex in gross pathology. There were no microscopic findings considered to be due to administration of the test material T-4388.
Based on the results of this study a dose of 1000 mg/kg/day was identified as no observed adverse effect level. Based on a slight increase in liver weight which was not accompanied by histopathologic changes and observed in females only. The no observed effect level is 250 mg/kg/day.
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