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Diss Factsheets
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EC number: 800-003-4 | CAS number: 1415316-96-9
- 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:
- other: Range-finding study, acceptable, well-documented study report which meets basic scientific principles
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Range-finding study
- GLP compliance:
- yes
- Limit test:
- no
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
- Batch: sample 929 from container B 810
- Physical state/appearance: Liquid / colorless
- Purity: >98.7%
- Homogeneity: homogeneous
- Stability: The stability under storage conditions was confirmed by reanalysis
- Storage conditions: Room temperature, without light and oxygen under N2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K Thomae GmbH, Biberach Germany
- Age at study initiation: 68-70 days
- Weight at study initiation: ca. 214 g
- Housing: individual in wire mesh cages
- Diet: Kliba rat/mouse laboratory diet, Klingenthalmühle AG Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum
- Acclimation period: 5 days
- Adaption period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- nose/head only
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The test substance was supplied to a two-component atomizer at a constant rate by means of a metric pump. An aerosol was generated by means of compressed air and passed into the inhalation system.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations: Target: 0; 0.1; 0.2; 0.4 mg/l (analytical determined: 0; 0.11; 0.21; 0.40 mg/l)
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1-4
- Length of cohabitation: 4 pm - 7.30 am
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy:sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- gestation days 6 - 15
- Frequency of treatment:
- 6h/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 0.1; 0.2; 0.4 mg/l (analytical determined: 0; 0.11; 0.21; 0.40 mg/l, head nose exposure)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Duration of test: 20 days
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Test group 0.4 mg/l: absolute and relative liver weight increased increase in sodium and creatinine serum concentrations decrease in cholesterol and triglycerides serum concentrations;
Test group 0.2 mg/l: relative liver weight increased increase in sodium and creatinine serum concentrations decrease in cholesterol and triglycerides serum concentrations;
Test group 0.1 mg/l: No treatment related effects.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- 0.2 mg/L air
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Test group 0.4 mg/l: significantly increased mean placental weights
Test group 0.2 mg/l: significantly increased mean placental weights
Effect levels (fetuses)
- Remarks on result:
- not determinable because of methodological limitations
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Results summay:
The exposure of pregnant female Wistar to an aerosol of Diethanolamine in a head/nose exposure systems for 6 h/day on day 6 through day 15 post coitum at concentrations of 0; 0.1; 0.2; 0.4 mg/l led at 0.4 mg/l to a marked indication of hepatotoxic effects (increase of absolute and relative liver weights, decrease in cholesterol and triglyceride serum concentration, increase in transaminase AST). At 0.2 mg/l relative liver weight was still increased and cholesterol and triglycerides decreased.
These findings were considered as clear indications for maternal toxicity.
Detailed results:
- Concentrations:
Target Measured
MMAD
(GSD)
0.1 mg/l, 0.11
mg/l 0.6
µm (4.5)
0.2 mg/l 0.21
mg/l 0.1.2
µm (3.6)
0.4 mg/l 0.40
mg/l 0.0.6
µm (4.5)
- Mortalities, clinical findings, body weight:
No deaths nor treatment related finding
Weight of placentae
No substance related effects were observed. The marginal,however statistically significant decrease in the mean placental weights in test groups 2 and 3 is without any biological relevance.
Applicant's summary and conclusion
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.
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