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EC number: 939-479-4 | CAS number: 1471311-60-0
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 10 Fischer 344 rats/sex were given drinking water formulated to supply 0, 100, 500, or 1000 mg DIPA/kg/day for 13 weeks. Additional groups of 10 rats/sex were maintained on untreated drinking water for 4 weeks after initially receiving the control or high dose level for 13 weeks to assess recovery from any treatment-related effects.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,1'-iminodipropan-2-ol
- EC Number:
- 203-820-9
- EC Name:
- 1,1'-iminodipropan-2-ol
- Cas Number:
- 110-97-4
- IUPAC Name:
- 1,1'-iminodipropan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Diisopropanolamine
- Analytical purity: ranged from 98.8 % - 99.6 % (GC/FID)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuously in drinking water
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 500 or 1000 mg/kg bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION: Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prestudy and during the last week of the study
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at necropsy
- Anaesthetic used for blood collection: Yes with methoxyflurane or CO2
- Animals fasted: No data
- How many animals: no data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at necropsy
- Animals fasted: No data
- How many animals: no data
Standard hematologic and clinical chemistry parameters were evaluated consistent with globally accepted regulatory guidelines (EEC, 1992; EPA, 1998; OECD, 1998; MITI, 1988).
URINALYSIS: Yes
- Time schedule for collection of urine: near end of study
- Metabolism cages used for collection of urine: No data
- Animals fasted: No
Standard urinalysis parameters were evaluated (EEC, 1992; EPA, 1998; OECD, 1998; MITI, 1988). - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
An extensive set of organs consistent with regulatory guidelines (EPA, 1998) including all organ systems and gonads and secondary sex organs of both sexes were examined histopathologically from the control and high dose animals with the kidneys, liver, lungs, urinary bladder and all gross lesions examined from the remaining rats. - Statistics:
- Consistent with the variety of data collected, a large number of statistical methods were employed. Means and standard deviations were calculated for all continuous data. These parameters were first examined for equality of variance using Bartlett’s test (a = 0.01; Winer, 1971). If the results of the Bartlett’s test were significant, the data were transformed in an attempt to obtain equality of variances. The order of transformations used was the common log, the inverse and the square root with the best fit used for subsequent statistical testing. Weekly body weights, feed and water consumption, clinical pathology parameters, terminal body weight, and organ weights were analyzed using parametric or non-parametric ANOVA, followed by Dunnett’s or Wilcoxon’s test for comparison to controls. Detailed clinical observations were analyzed by a Z-test of proportions. As statistical interactions (i.e., time by dose or sex by dose) were identified in several of the tests, the alpha levels for interaction terms were set a priori at 0.01–0.10, with Bonferroni’s correction. The alpha level for comparison of individual dose groups to controls was set a priori at 0.05.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
All rats given up to 1000 mg DIPA/kg/day via the drinking water survived the study period and only minor effects from treatment were found.
BODY WEIGHT AND WEIGHT GAIN
High dose males and females gained 4–5% less body weight than controls after 13 weeks of dosing.
FOOD CONSUMPTION
Rats given 1000 mg/kg/day consumed slightly less feed than controls (2–3%).
WATER CONSUMPTION
Total water consumption by high dose males and females decreased 7.5% and 18% relative to controls, respectively.
OPHTHALMOSCOPIC EXAMINATION
No treatment-related changes in ophthalmic parameters were noted.
HAEMATOLOGY
Hematologic parameters and prothrombin times were unaffected by DIPA ingestion.
CLINICAL CHEMISTRY
There were minimal, but statistically identified, differences noted for cholesterol (increased), albumin (decreased) and phosphorus (decreased) for males given 1000 mg/kg/day.
URINALYSIS
Rats given 1000 mg/kg/day had increased urine specific gravity and the females had decreased urine volume.
ORGAN WEIGHTS
Absolute and relative kidney weights were increased for males and females receiving 500 or 1000 mg/kg/day and the absolute kidney weight also was increased for males given 100 mg/kg/day.
GROSS PATHOLOGY and HISTOPATHOLOGY:
Despite the kidney weight increase, there were no gross or histopathologic effects related to treatment.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: increased mean kidney weights.
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: increased mean kidney weights.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Effects of DIPA given in drinking water to F344 rats for 13 weeks.
Dose level (mg/kg/day | ||||||||
Males | Females | |||||||
0 | 100 | 500 | 1000 | 0 | 100 | 500 | 1000 | |
Body weight - day 90 (g) | 348.5 | 354.2 | 357.6 | 340.9 | 196.7 | 194.6 | 195.1 | 192.1 |
Body weight gain (g) | 176.5 | 182.1 | 185.8 | 169.3 | 85.4 | 83.3 | 83.2 | 80.8 |
Water consumption (g) | 2048.8 | 2061.2 | 2119.0 | 1985.1 | 1890.6 | 1999.3 | 2045.8 | 1549.9 |
Feed consumption (g) | 1554.1 | 1598.8 | 1593.6 | 1508.3 | 1127.0 | 1138.3 | 1138.1 | 1107.9 |
Cholesterol (mg/dL) | 60 | 60 | 64 | 70* | 19 | 18 | 18 | 21 |
Albumin (g/dL) | 3.5 | 3.5 | 3.5 | 3.4* | 95 | 98 | 97 | 93 |
Phosphorus (mg/dL) | 10.5 | 10.6 | 10.4 | 9.7* | 3.4 | 3.5 | 3.4 | 3.3 |
Serum urea nitrogen (mg/dL) | 17 | 17 | 17 | 17 | 10.2 | 9.5 | 9.5 | 9.6 |
Urine volume (mL) | 4.5 | 4.4 | 4.9 | 4.6 | 2.9 | 3.7 | 3.0 | 1.4 |
Urine specific gravity | 1.067 | 1.068 | 1.072 | 1.079* | 1.070 | 1.065 | 1.070 | 1.114* |
Terminal body weight (g) | 319.7 | 329.7 | 332.9 | 319.5 | 179.9 | 179.4 | 181.2 | 181.1 |
Kidney body weight (g) | 2.146 | 2.357* | 2.494* | 2.594* | 1.276 | 1.301 | 1.374* | 1.466* |
Relative kidney weight (g/100g) | 0.671 | 0.716 | 0.749* | 0.813* | 0.709 | 0.726 | 0.759* | 0.810* |
Statisticially different from control mean by Dunnett´s test: α =0.05.
The endpoints affected by DIPA ingestion were examined in additional groups of control and high dose group rats following the 4-week recovery period. Water consumption of the treated rats remained below controls by approximately the same degree as at the end of the dosing period, but all other affected endpoints demonstrated reversibility. Absolute and relative kidney weights of rats previously given DIPA were still above controls, but the differences were about one-half of those immediately following 13 weeks dosing; mean relative kidney weights were increased 11% and 6.6% relative to controls for males and females, respectively. No treatment-related renal histopathological changes were observed.
Applicant's summary and conclusion
- Conclusions:
- Oral administration of DIPA to rats for 90 days resulted in increased kidney weights both in male and female animales. The lowest NOAEL recorded was for males, at 100 mg/kg bw.
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