Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jan to 9 Feb 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study to GLP with slight deviations which are not expected to affect the outcome.
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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- temperature slightly outside recommended range
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- temperature slightly outside recommended range
- 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: 93%
- 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc (Kalamazoo, MI)
- Age at study initiation: 3 months
- Weight at study initiation: 2.3-2.6 kg
- Fasting period before study: Not specified
- Housing: Not specified
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/-3 [OECD guideline recommends 20 +/-3, but unlikely to affect outcome]
- Humidity (%): 40-60
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approx 10 by 14 cm
- % coverage: Approx 10%
- Type of wrap if used: Gauze/cotton patch held in place by an elastic rabbit jacket
The trunk of each rabbit was clipped free of fur the day prior to DEIPA application
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin wiped thoroughly with a water moistened soft disposable towel and dried with a soft disposable towel
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 100%
- Constant volume or concentration used: yes
VEHICLE
Not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- 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: Observations at least once per work 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, including outliers.
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 intervals not applicable since no deaths occurred
- Mortality:
- All rabbits survived to the end of the 2-week observation period
- Clinical signs:
- other: No clinical signs of systemic toxicity. All rabbits had reddened and/or thickened skin at the test site on day 2 which was resolved by day 3 in all rabbits apart from one male whose skin was reddened on day 3 and 4 with flaking/scaling skin on day 4 which
- Gross pathology:
- No visible lessions
- Other findings:
- None reported
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP acute dermal toxicity study, conducted according to OECD Guideline 402, a dermal LD50 of greater than 2000 mg/kg bw (limit test) was determined for DEIPA in New Zealand White rabbits.
- Executive summary:
In a GLP acute dermal toxicity study, conducted according to OECD Guideline 402, groups of 5 male and 5 female New Zealand White rabbits received a single application of 2000 mg/kg bw of neat DEIPA to clipped skin of the trunk. This treated area was subsequently covered for 24 hours and the application site washed on patch removal. 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 2-week observation period and there were no signs of systemic toxicity. All male and female rabbits had reddened and/or thickened skin at the site of application on day 2. This was resolved by day 3 in all rabbits apart from one male whose skin was reddened on day 3 and 4 with flaking/scaling skin on day 4, returning to normal by day 7. A female was also noted to have had faecal soiling of the perineum on test day 2 only. All rabbits gained or maintained body weight over the 2 week period following a transient weight loss on day 1 and/or 2. There were no treatment-related gross pathological observations.
From the results of this study, an acute dermal LD50 of greater than 2000 mg/kg bw (limit test) was determined in rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.