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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol
EC number: 943-503-9 | 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:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods (study conducted in collaboration with the National Institute of Environmental Sciences, US) According to ECHA Practical Guide 6 the maximum score for read across is rel. 2
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicity of Diethanolamine. 2. Drinking Water and Topical Applicationn Exposures in B6C3F1 Mice
- Author:
- Melnick RL et al.
- Year:
- 1 994
- Bibliographic source:
- Journal of Applied Toxicology, 14, 11-19
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 10 mice of each sex were administered 2,2'-iminodiethanol in 95 % ethanol once per day for 13 weeks (no recovery group). Examinations included clinical chemistry, complete necropsy, organ weights, histopathology, and statistical evaluation thereof.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2'-iminodiethanol
- Details on test material:
- - Name of test material (as cited in study report): Diethanolamine (DEA; CAS no. 111-42-2)
- Analytical purity: > 99 %
- Source: Kodak Laboratory and Specialty Chemicals (Rochester, NY, USA)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: B6C3F1 mice
- Source: Taconic Farms, Germantown, New York, US
- Age at study initiation: approx. 6 weeks
- Weight at study initiation (mean): males 22.5-23.2 g, females 18.6-19.5 g
- Housing: individually
- Diet and water: ad libitum
- Acclimation period: 12-13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 +/- (72 +/- 3 °F)
- Humidity (%): 50 +/- 15
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- ethanol
- Details on exposure:
- 2,2-iminodiethanol in 95 % ethanol: concentrations were 0, 37.5, 75, 150, 300 and 600 mg/mL. The volume of the dosing solution was adjusted weekly based on the most recent mean body weight of each dose group, to provide daily doses of 0, 80, 160, 320, 630, or 1250 mg/kg body wt.
The dosing solution was applied to the shaved back of each animal (unoccluded), from the mid-back to the interscapular region, using a calibrated micropipette. Mice were shaved at 1-week intervals. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Dose formulations were analyzed by gas chromatography before and after administration to animals and found to be within 15 % of the theoretical values.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- once daily, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 37.5, 75, 150, 300 and 600 mg/mL
Basis:
other: concentrations
- Remarks:
- Doses / Concentrations:
0, 80, 160, 320, 630, and 1250 mg/kg
Basis:
other: daily doses (converted values from NTP-report)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Groups of 10 animals per sex were administered 2,2'-iminodiethanol in 95 % ethanol once per day (excluding weekends) for 13 weeks (no recovery period).
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes, no further data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No
CLINICAL CHEMISTRY: Yes
Clinical pathology studies were performed on all mice that survived until the end of the studies. Biochemical analyses were performed on blood samples collected in Microtainers with no preservative or anticoagulant.
- Parameters examined included serum sorbitol dehydrogenase (SDH), alanine arninotransferase (ALT), total protein (TP), albumin, urea nitrogen (UN). creatinine, glucose and total bile acids.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, complete necropsies were performed on all animals. The brain, heart, right kidney, liver, lung, right testis and thymus were weighed.
HISTOPATHOLOGY: Yes, complete histopathological examinations were performed on all control animals, all early death animals and all animals in the highest dose groups with at least 60 % survivors. Target tissues were examined in animals from lower dose groups until a no-effect level was determined. All lesions observed at necropsy were examined microscopically. - Statistics:
- Organ and body weight data were analyzed using the parametric multiple comparisons procedures of Williams (Biometrics 27, 103-1 17, 1971; Biometrics 28, 519-531, 1972) and Dunnett (J. Am. Stat. Assoc. 50, 1095-1121, 1955). Clinical chemistry and hematology data were analyzed using the non-parametric multiple comparison methods of Shirley (Biometrics 33, 386-389, 1977) and Dunn (Technometrics 6, 241-252, 1964).
Results and discussion
Results of examinations
- Details on results:
- Text from NTP report:
"Two males and four females administered 1,250 mg/kg died before the end of the study. Final mean body weights of males receiving 1,250 mg/kg were slightly less than that of the vehicle controls, but final mean body weights of other dosed groups were similar to those of the vehicle controls. Liver and kidney weights were significantly increased compared to the vehicle controls in groups of males administered 160 mg/kg or greater and females receiving 80 mg/kg or greater. Serum alanine aminotransferase and sorbitol dehydrogenase activities were significantly increased in males that received 630 or 1,250 mg/kg, and serum alanine aminotransferase activity was increased in females that received 1,250 mg/kg.
Acanthosis occurred at the site of application in all animals administered diethanolamine but was not observed in the vehicle controls. Cytologic alteration of the liver was observed in all groups of male mice administered diethanolamine and in females receiving 160 mg/kg or greater. Hepatocellular necrosis was also present in several dosed groups of males, especially groups receiving 320 mg/kg or greater. Renal tubule necrosis and cardiac degeneration were observed in males and females receiving 1,250 mg/kg."
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Remarks:
- local
- Effect level:
- 80 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Based on local effects at the site of application up to the lowest dose (80 mg/kg)
- Dose descriptor:
- other: no reliable systemic threshold identified
- Sex:
- male/female
- Basis for effect level:
- other: Cytological alteration of the liver was evident up to the lowest dose (80 mg/kg). However, since ingestion by licking must be assumed (cp. MAK documentation for Diethanolamine, 2000) no reliable dermal, systemic threshold identified.
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The substance contains approx. 40 % 2,2'-iminodiethanol (CAS No 111-42-2), therefore data of 2,2'-iminodiethanol are relevant for toxicological assessment and were thus included in the IUCLID.
Applicant's summary and conclusion
- Executive summary:
Groups of 10 male and 10 female B6C3F mice received doses of 0, 80, 160, 320, 630, or 1250 mg/kg 2,2'-iminodiethanol by dermal application to the shaved interscapular region 5 days per week for 13 weeks. All surviving animals were sacificed at the end of the exposure period, that means no recovery group was implemented. The examinations included clinical chemistry, complete necropsy, organ weights, histopathology, and statistical evaluation thereof.
The result is summarized in the NTP-report:
"Two males and four females administered 1,250 mg/kg died before the end of the study. Final mean body weights of males receiving 1,250 mg/kg were slightly less than that of the vehicle controls, but final mean body weights of other dosed groups were similar to those of the vehicle controls. Liver and kidney weights were significantly increased compared to the vehicle controls in groups of males administered 160 mg/kg or greater and females receiving 80 mg/kg or greater. Serum alanine aminotransferase and sorbitol dehydrogenase activities were significantly increased in males that received 630 or 1,250 mg/kg, and serum alanine aminotransferase activity was increased in females that received 1,250 mg/kg.
Acanthosis occurred at the site of application in all animals administered diethanolamine but was not observed in the vehicle controls. Cytologic alteration of the liver was observed in all groups of male mice administered diethanolamine and in females receiving 160 mg/kg or greater. Hepatocellular necrosis was also present in several dosed groups of males, especially groups receiving 320 mg/kg or greater. Renal tubule necrosis and cardiac degeneration were observed in males and females receiving 1,250 mg/kg."
According to Melnick et al., 1994, a "NOAEL was not achieved for cytological alteration of the liver .....".
However, no reliable dermal threshold can be established since, "the substance was applied non-occlusively in 95 % ethanol as a vehicle. Therefore, ingestion by licking must also be assumed" (MAK documentation for Diethanolamine, 2000; http://onlinelibrary.wiley.com/doi/10.1002/3527600418.mb11142e3014/pdf).
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.