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Diss Factsheets
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EC number: 944-951-8 | CAS number: -
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1998
- Deviations:
- no
- 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
- Molecular formula:
- C6H15NO2
- IUPAC Name:
- 1,1'-iminodipropan-2-ol
Constituent 1
- Specific details on test material used for the study:
- Commercial DIPA (CAS 000110-97-4) was obtained from the Dow Chemical Company (Midland, MI).
The purities of four lots of DIPA used for these studies ranged from 98.8% to 99.6%, as determined by GC/FID.
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc. (Kingston, New York and Raleigh, North Carolina)
- Age at study initiation: approximately 6 weeks of age
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet: ad libitum LabDiet#5002 Certified Rodent Diet (PMI Nutrition International, St. Louis, MO)
- Water: ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21–25
- Humidity (%): 45–60%
- Air changes (per hr): 12–15 room air changes/h
- Photoperiod (hrs dark / hrs light): 12 h photocycle
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on oral exposure:
- Drinking water formulated with test article to supply 0, 100, 500, or 1000 mg DIPA/kg/day for 13 weeks
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of DIPA in all dose solutions for all studies ranged from 95% to 105% of target.
- Duration of treatment / exposure:
- 13 weeks (90 days)
- Frequency of treatment:
- Continuously via drinking water.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: dose levels were based upon the prior 2-week drinking water study.
- Eficiency of the dosing: Water consumption was between 98% and 106% of targeted levels.
- Rationale for selecting satellite groups: assess recovery from any treatment-related effects.
- Post-exposure recovery period in satellite groups: 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. - Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations checked were included.
DETAILED OBSERVATIONS/EXAMINATIONS: Yes
- Time schedule: weekly, detailed (handheld) clinical examinations, body weight, water and feed consumption
OPHTHALMOSCOPIC EXAMINATION: Yes / No / Not specified
- conducted prestudy and during the last week of treatment:
HAEMATOLOGY & CLINICAL CHEMISTRY: Yes
- on blood samples collected at necropsy
URINALYSIS: Yes
on samples collected near the end of each study
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
OTHER:
- electrolyte parameters on blood samples collected at necropsy - Sacrifice and pathology:
- Histopathologic examination was conducted on an extensive list of organs from all control and high dose level rats along with selected organs from the low- and middle-dose animals
- Other examinations:
- - selected organ weights
- Statistics:
- Weekly body weights, feed and water consumption, clinical pathology parameters, terminal body weight, organ weights: Parametric or non-parametric ANOVA, followed by Dunnett’s or Wilcoxon’s test for comparison to controls
Detailed clinical observations: Z-test of proportions according to Bruning and Kintz
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Not significant, only minor effects from treatment.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose males and females gained 4–5% less body weight than controls after 13 weeks of dosing.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- Rats given 1000 mg/kg/day also consumed slightly less feed than controls (2–3%) and consistently weighed slightly less than controls.
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Water consumption by high dose males and females decreased 7.5% and 18% relative to controls
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- There were minimal, but statistically identified, differences noted for cholesterol (increased), albumin (decreased) and phosphorus (decreased) for males given 1000 mg/kg/day
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Consistent with decreased water consumption, rats given 1000 mg/kg/day had increased urine specific gravity and the females had decreased urine volume, which were considered secondary adaptive effects.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 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. Male kidney weights were increased to a greater extent than the females with the mean relative kidney weight of males receiving 1000 mg/kg/day 21% greater than controls, while the females from this dose level were 14% greater than controls. Despite the kidney weight increase, there were no gross or histopathologic findings in kidney tissue related to treatment.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Details on results:
- 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.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect levels (NOAEL) in the DIPA toxicity studies for systemic toxicity were 100 mg/kg/day for males and 500 mg/kg/day for females in the 13-week drinking water study based upon the increased mean kidney weights.
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