Registration Dossier
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EC number: 201-162-7 | CAS number: 78-96-6
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - see justifications attached to IUCLID section 13.2.
- Justification WoE_RDT_Reprotox_Feb2019
- Justification RA_CAS 122-20-2_Dev.tox.2ndspecies_Nov2018
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Principles of method if other than guideline:
- Female onn-pregnant rabbits were administered the test substance orally by gavage for 21 days, after blood sampling all animals will be sacrificed and examined.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1',1''-nitrilotripropan-2-ol
- EC Number:
- 204-528-4
- EC Name:
- 1,1',1''-nitrilotripropan-2-ol
- Cas Number:
- 122-20-3
- Molecular formula:
- C9H21NO3
- IUPAC Name:
- 1-[bis(2-hydroxypropyl)amino]propan-2-ol
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH / Charles River Laboratories, France
- Housing: single
- Diet (e.g. ad libitum): Pelleted Kliba maintenance diet rabbit and guinea pig “GLP”, Provimi Kliba SA, Kaiseraugst/Switzerland; ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Dose: 1000 mg/kg bw
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- daily
- No. of animals per sex per dose:
- Control group: 3 animals
Test group (1000 mg/kg bw): 5 animals (due to the premature dead of 2 animals (1 found dead and 1 sacrificed after gavage error) from test group 1 (1000 mg/kg bw/d) 2 animals will be added) - Control animals:
- yes, concurrent no treatment
- Details on study design:
- The test substance was administered to the animals orally by gavage for 21 days. For this purpose, disposable syringes (e.g. B. Braun Melsungen AG, Melsungen, Germany) and suitable gavage tubes (e.g. Nelaton soft rubber tubes, Willy Ruesch GmbH, Kernen, Germany) were used. During the study, all animals were observed for any clinically abnormal signs. One day after the last administration blood samples were obtained from all surviving animals from the ear veins. After blood sampling all animals were sacrificed and examined.
Examinations
- Maternal examinations:
- Mortality: A check for moribund and dead animals was made twice daily from Mondays to Fridays and once daily on Saturdays, Sundays and public holidays.
Clinical signs: A cageside examination was conducted at least once daily for any signs of morbidity, pertinent behavioral changes and/or signs of overt toxicity. During the administration period all animals were checked daily for any abnormal clinically signs before the administration as well as within 5 hours after the administration. Abnormalities and changes were documented for each animal.
Food consumption: Food consumption was recorded daily for days -4 - 0 and 0 - 21.
Body weight: Body weights was recorded on day 0, 2, 4, 6, 9, 11, 14, 16, 20 and 21.
Post-Mortem Examinations:The surviving animals were sacrificed by an intravenous injection of pentobarbital (dose: 2 mL/animal). After exsanguination the animals were necropsied and examined according to 3.12. Animals which died intercurrently or were sacrificed in a moribund state were necropsied in the same way as soon as possible after their death (with the exception of the organ weights).
Clinical Pathology: Blood samples were taken from the ear veins. The following parameters were examined: Hematology: Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, differential blood count, reticulocytes. Clinical chemistry: Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase,serum γ-glutamyl transferase, Inorg. phosphate, Calcium, Urea, Creatinine, Glucose, total bilirubin, total protein, Albumin, Globulins, Triglycerides, Cholesterol.
Pathology:
Necropsy: The sacrificed animals were necropsied and assessed by gross pathology. All animals which died intercurrently or were sacrificed in a moribund state were necropsied as soon as possible after their death and assessed by gross pathology.
Organ weights: The following weights were determined in all does sacrificed on schedule: Adrenal glands, kidneys, liver and spleen. The final body weights (ToxLims-System) will be transferred to the ACOPAT-System to calculate the relative organ weights.
Organ / tissue fixation: The following organs or tissues were fixed in 4% buffered formaldehyde solution: All gross lesions, adrenal glands, kidneys, liver and spleen. - Statistics:
- Dunnett-test (two-sided)
Kruskal-Wallis and Wilcoxon test
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Details on results:
- The test substance was administered dissolved in drinking water for 21 days to groups of 3 – 5 female New Zealand White rabbits, via daily gavage. The dose levels were 0 and 1000 mg/kg body weight/day.
In the dose group (1000 mg/kg bw/d) all 5 females had reduced food consumption and lost body weight throughout the study. These animals also had reduced feces or diarrhea. Two rabbits died on the 3rd and 5th treatment day, respectively. The deceased animals showed no other pre-terminal clinical signs of toxicity, nor were there any specific necropsy findings.
Any other information on results incl. tables
Female non-pregnant rabbits were exposed to the test substance.
Applicant's summary and conclusion
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