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EC number: 229-764-5 | CAS number: 6712-98-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jan to 9 Feb 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study 401 (1987; available at time of study, deleted in 2002) to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
- EC Number:
- 229-764-5
- EC Name:
- 1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
- Cas Number:
- 6712-98-7
- Molecular formula:
- C7H17NO3
- IUPAC Name:
- 1-[bis(2-hydroxyethyl)amino]propan-2-ol
- Test material form:
- other: Clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Diethanolisopropanolamine (DEIPA)
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: 92.9 %
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: Not specified
- Lot/batch No.: 980035B
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc. (Raleigh, NC)
- Age at study initiation: 2 months
- Weight at study initiation: 111-226 g
- Fasting period before study: Fasted the night prior to treatment
- Housing: No data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3oC
- Humidity (%): 40-70%
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Not applicable
- Doses:
- 2000 mg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed at least once per day, weighed pre study and on test days 1, 2, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, eye examinations - Statistics:
- Mean and standard deviations calculated for body weights, outliers included.
Results and discussion
- Preliminary study:
- None
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence level not applicable as no deaths occurred.
- Mortality:
- All rats survived to the end of the 2-week observation period.
- Clinical signs:
- other: On test day 1, there was faecal soiling in 3 males and 3 females, watery or soft faeces in 1 male and 2 females and diarrhoea in 1 female. All signs resolved for all animals on test days 2 or 3. No other treatment-related clinical signs observed for the
- Gross pathology:
- No treatment-related gross pathologic observations.
- Other findings:
- 1 male had a cloudy eye on test day 10 and one female had urine perineal soiling on test day 15. The investigators interpreted these observations to be not treatment-related.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the results of this GLP study conducted according to OECD Guideline 401 (1987; available at time of study) an acute oral LD50 of DEIPA in rats was determined to be greater than 2000 mg/kg bw (limit test).
- Executive summary:
In a GLP acute oral toxicity study, conducted according to OECD guideline 401 (1987; available at time of study) groups of 5 male and female Fischer 344 rats were administered a single dose of 2000 mg/kg bw of neat DEIPA by gavage. During the two-week observation period the animals were frequently evaluated for weight changes and clinical signs of toxicity. All survivors were examined for gross pathological changes.
No mortality occurred over the two-week observation period and very few clinical treatment-related signs were observed. Faecal soiling in 3 males and 3 females, watery or soft faeces in a male and 2 females and diarrhoea in a female were noted on test day 1, which resolved for all animals by test day 3. All rats gained body weight over the 2-week ovservation period following a transient decrease in body weight on test day 1. There were no treatment-related gross pathological observations.
From the results of this study, an acute oral LD50 of DEIPA in rats was determined to be greater than 2000 mg/kg bw (limit test).
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