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EC number: 224-536-1 | CAS number: 4402-30-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 27. Jan 1994 - 21. Feb 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 414), GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
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
- Details on test material:
- - Name of test material (as cited in study report): Triisopropanolamine
- Analytical purity: 92 %
- Lot/batch No.: 10-4852
- Storage condition of test material: Room temperature, under nitrogen atmosphere
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: THOMAE, Biberach an der Riss, FRG
- Age at study initiation: 77-89 days
- Weight at study initiation: 242 g (mean)
- Housing: singly in type DK III stainless steel wire mesh cage.
- Diet: ground Kliba 343 feed, Klingenthalmuehle AG, Kaiseraugst, Switzerland, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: doubly distilled water
- Details on exposure:
- Doses of 0, 100, 400 and 1000 mg/kg bw/day were administered in a volume of 10 ml/kg, at a concentration of 0, 1000, 4000 and 10000 mg/100ml, respectively.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test substance: purity and stability were analyzed by gas chromatography (GC); and homogeneity was proven visually.
Test solutions: analysis of stability (for 3 hrs) in double distilled water was carried out in a range-finding study. Concentrations were analyzed twice during the study by GC. Test solutions were freshly prepared on the day of dosing. - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- on day 6 through day 15 post coitum (p.c.)
(Sacrifice on day 20 p.c.) - Frequency of treatment:
- once a day during the period of major organogenesis (day 6 to day 15 p.c.)
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 100; 400; 1000 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once a day and more often when clinical signs of toxicity were elicited. Mortality was check twice a day on workdays and once a day during weekends and public holidays.
BODY WEIGHT and FOOD CONSUMPTION: Yes
- Time schedule for examinations: days 0 (only bw), 1, 3, 6, 8, 10, 13, 15, 17, 20 p.c.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: uterus and ovaries after gross pathology
OTHER: The correct body weight gain was calculated after terminal sacrifice. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: furthermore, calculations of conception rate and pre- and postimplantation losses were carried out - Fetal examinations:
- - External examinations: Yes: all per litter: fetus was weighed, sexed, examined macroscopically for external findings, and viability, condition of the placentae, umbilical cords, fetal membranes and fluids were examined.
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No - Statistics:
- The data were evaluated statistically using the computer systems of the Department of Toxicology of BASF AG. The Dunnett-test was used for a simultaneous comparison of several dose groups with the control. The hypothesis of equal means was tested. This test was performed two-sided and was used for the statistical evaluation of the following parameters: food consumption, body weight, body weight change, corrected body weight gain (net maternal body weight change), weight of the uterus before it was opened, number of corpora lutea, number of implantations, number of resorptions and number of live fetuses, proportion of preimplantation loss, postimplantation loss, resorptions and live fetuses in each litter, litter mean fetal body weight and litter mean placental weight. Fisher's Exact Test was used for a pairwise comparison of each dose group with the control for the hypothesis of equal proportions. This test was performed one-sided and was used for female mortality, females pregnant at terminal sacrifice and the number of litters with fetal findings. The Wilcoxon-Test was used for a comparison of each dose group with the control for the hypothesis of equal medians. This test was performed one-sided and was used for the proportion of fetuses with malformations, variations, retardations and/or unclassified observations in each litter. If the results of these tests were significant, labels (* for p< 0.05, ** for p< 0.01) were printed in the summary tables.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
In the 1000 mg/kg group statistically significantly decreased food consumption at the beginning of the treatment period (days 6-10 p.c.; about 13% (days 6 to 8 p.c.) or about 16% (days 8 to 10 p.c.) lower than the values of the concurrent control group. There were no statistically significant differences between the controls and the substance-treated dams concerning mean body weights. At the beginning of the treatment period (days 6-8 p.c.), however, the dams of the highest dose group (1,000 mg/kg body weight/day) showed a statistically significantly reduced body weight gain (only about 36% of the weight gain of the concurrent control group; see table in remarks on results). The corrected body weight gain (terminal body weight on day 20 p.c. minus weight of the uterus before it was opened minus body weight on day 6 p.c.) was statistically significantly lower in the high dose group (about 87% of the value of the concurrent control group), which is related to the test substance administration (see table in remarks on results). There were no substance-related and/or biologically relevant differences between the groups in conception rate, in the mean number of corpora lutea and implantation sites or in the values calculated for the pre- and the postimplantation losses, the number of resorptions and viable fetuses. The differences evident are considered to be incidental and within the normal range of deviations for animals of this strain and age.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The few statistically significant differences on embryo-/fetotoxicity, which occurred were exclusively related to fetal skeletal variations and retardations. These findings consisted of: an increased rate of affected fetuses/litter and an increased litter incidence with shortened 13th rib(s) at 100, 400 and 1,000 mg/kg bw/day, respectively; a consequently increased rate of low and intermediate dose fetuses/litter with total skeletal variations; an increased litter incidence of incompletely ossified or smaller sternebra(e) in the 400 mg/kg body weight group. These findings are considered to be spontaneous in nature because no dose-response relationship is given and/or the respective values are fully in the historical control range.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Mean maternal body weight change during gestation (grams):
0 mg/kg bw/d(n = 25) | 100 mg/kg bw/d(n = 24) | 400 mg/kg bw/d(n = 25) | 1000 mg/kg bw/d(n = 23) | ||
Days 0 - 1 | 4.3±3.76 | 3.7±3.60 | 4.3±3.41 | 4.3±2.89 | |
Days 1 - 3 | 11.7±3.56 | 11.9±3.41 | 11.7±3.77 | 11.8±2.95 | |
Days 3 - 6 | 13.0±4.56 | 12.1±4.40 | 13.1±4.37 | 12.5±3.39 | |
Days 6 - 8 | 7.5±3.90 | 7.4±4.21 | 5.0±4.26 | 2.7±3.93** | |
Days 8 - 10 | 9.9±4.59 | 9.4±5.15 | 11.4±4.43 | 8.0±3.72 | |
Days 10 - 13 | 17.5±3.57 | 17.1±4.92 | 19.1±5.42 | 19.0±4.98 | |
Days 13 - 15 | 11.7±4.51 | 11.9±4.15 | 12.5±4.36 | 13.7±4.62 | |
Days 15 - 17 | 25.4±6.47 | 25.8±5.23 | 25.3±4.38 | 26.6±3.60 | |
Days 17 - 20 | 50.3±10.57 | 49.2±6.64 | 51.8±7.58 | 52.6±5.56 |
**: p ≤ 0.01; Dunnett-test.
Mean gravid uterine Weights and net maternal body weight change (grams):
0 mg/kg bw/d(n = 25) | 100 mg/kg bw/d(n = 24) | 400 mg/kg bw/d(n = 25) | 1000 mg/kg bw/d(n = 23) | ||
Gravid uterus | 78.3±19.22 | 80.3±10.49 | 82.5±13.18 | 84.4±10.16 | |
Carcass | 317.7±22.09 | 310.8±20.66 | 314.3±22.22 | 306.2±13.17 | |
Net weight change from day 6 | 44.1±8.54 | 40.4±7.52 | 42.6±7.06 | 38.2±6.72* |
*: p ≤ 0.05; Dunnett-test.
Under the conditions of this full-scale prenatal toxicity study, the administration of Triisopropanolamine to pregnant female Wistar rats during organogenesis elicited overt signs of maternal toxicity at 1000 mg/kg body weight/day, while 100 or 400 mg/kg body weight/day were tolerated by the dams without any substance-induced findings. The gestational parameters were not influenced by the test substance administration in any of the three test groups.
No signs of embryo-/fetotoxicity, especially no substance-induced indications of teratogenicity were noted up to and including the dose of 1,000 mg/kg body weight/day.
Therefore, the no observed adverse effect level (NOAEL) for the dams in this full-scale prenatal toxicity study is 400 mg/kg body weight/day, while it is 1000 mg/kg body weight/day for the fetal organism.
Applicant's summary and conclusion
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