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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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2006-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study is performed with diisopropanolamine (DIPA) as analogue for aminopropanol with the amine as common functional group. 3-aminopropan-1-ol is one of the constituents of Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide.at a molar ratio of 1:1. The process used is a pseudo acid – base reaction in water that leads always to a mixture of the “amide” and the “salt” part. Both entities are required for the applications performances. With the manufacturing process used here it is not possible to separate the amide and salt part from the water phase. The 3-aminopropan-1-ol is the kation of the salt part.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- Organisation for Economic Co-Operation and Development (OECD), 1981. OECD guidelines for testing of chemicals. Section 4, Health Effects, Paris.
- Deviations:
- no
- GLP compliance:
- yes
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:
- Source: obtained from The Dow Chemical Company (Midland, MI).
Puritie: 98.8% to 99.6%
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
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- deionized water
- Details on exposure:
- 0, 100, 500 or 750 mg DIPA/kg/day was applied to an approximately 2 x 2 cm interscapular-dorsal area of groups of five Fischer 344 rats/sex/dose level 5 days/week for 4 weeks. Hence, the actual dosages were: 25, 125 and 187.5 mg/ cm2. Application site skin was clipped free of hair, covered with an occlusive wrap during the dosing period each day, and was reclipped as necessary during the dosing period.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of DIPA in all dose solutions ranged from 95% to 105% of target.
- Duration of treatment / exposure:
- 4 weeks (28 days)
- Frequency of treatment:
- 5 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Dose selection rationale: determined from a 4-day dermal irritation probe study in which daily application of 1000 mg/kg/day was determined to be too irritating for prolonged administration.
- Procedure of exposure: Application site skin was clipped free of hair, covered with an occlusive wrap during the dosing period each day, and was reclipped as necessary during the dosing period. The wraps were removed after 6 h and the treated sites were washed by gentle padding with watersoaked gauze.
- Scoring: Skin site of application was graded at the end of each week and the dosing period for erythema and eschar, edema, scaling and fissuring, and presence of scabs - Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- Weekly and terminal body weights, organ weights (absolute and relative), clinical pathology parameters, urine specific gravity
Standard hematologic and clinical chemistry parameters - Sacrifice and pathology:
- - A complete necropsy was conducted on all animals.
- The adrenal glands, brain, heart, kidneys, liver, and ovaries or testes were weighed from all animals.
- Representative samples of a complete set of organs were collected and preserved in neutral, phosphate-buffered 10% formalin (NBF).
- Skin specimens were collected from the treated site and an adjacent untreated site in addition to a distant untreated site and histologic examination was made of the skin from treated, untreated adjacent and distal sites from all rats.
- Examination included an extensive set of organs consistent with regulatory guidelines (EPA, 1998), i.e. 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.
- Tissues were prepared by standard techniques, embedded in paraffin, sectioned approximately 6 lm thick, stained with hematoxylin and eosin, and examined by a veterinary pathologist using a light microscope. - Statistics:
- Weekly body weights: Three-way, repeated measures ANOVA, with body weights the repeated measure Dunnett’s test for comparison to controls
Terminal body weight, organ weights (absolute and relative), clinical pathology parameters, urine specific gravity: Two-way ANOVA, separate one-way ANOVA for each sex if sex by dose significant Dunnett’s test for comparison to controls
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Slightly to mildly irritating at 500 and 750 mg/kg/day. Over the course of the study from day 12, erythema was noted for all five males and three females treated with 750 mg/kg/day and two males and two females treated with 500 mg/kg/day. The erythema was graded as very slight to slight. During the course of the study after day 18, scabs were noted at the treatment site of one male and two females at 500 mg/kg/day, and of two males and three females at 750 mg/kg/day.
- 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 specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight hyperkeratosis of the treated site in all rats given 750 mg/kg/day and very slight hyperkeratosis in two males and two females given 500 mg/kg/day.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- dermal irritation
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- urinalysis
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect level (NOAEL) was >750 mg/kg/day in the 4-week dermal study,
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