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EC number: 263-157-6 | CAS number: 61790-66-7
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 79/831, Annex V, Method No. 431
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 931-329-6
- Cas Number:
- 68155-07-7
- Molecular formula:
- The alkyl chain length of the amide ranges between 8 and 18 carbon atoms
- IUPAC Name:
- Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
- 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
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeders were purchased from G1. Bomholtgard Ltd., but the mice used were born in the Scantox Laboratories
- Age at study initiation: 6-7 wk
- Weight at study initiation: 25-29 g
- Assigned to test groups randomly: Yes, in 5 groups
- Fasting period before study: No
- Housing: 5 animals/cage, males and females separately in type III Macrolone cages, bedding used was special softwood sawdust "Spanvall Special White " from Spanvall Ltd., DK-4535 Vallekilde
- Diet: Complete rodent diet "Altromin 1314" from Chr. Petersen Ltd., DK-4100 Ringsted, ad libitum
- Water (e.g. ad libitum): Drinking water adjusted to pH 2.5 with hydrochloric acid
ENVIRONMENTAL CONDITIONS
- Temperature: 21±2 °C
- Humidity (%): 55 ± 15%
- Air changes: 10 per hr
- Photoperiod: 12 hrs dark/12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dilution of the test material in distilled water
- Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48 and 72 h
Doses / concentrations
- Dose / conc.:
- 15 000 mg/kg bw/day (nominal)
- Remarks:
- equivalent to 14.7 mL/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: Oral
- Doses / concentrations: 30 mg/10 mL
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Preliminary investigations - A few mice were treated orally by various concentrations of the test material diluted with distilled water. Thereby the maximum tolerated dose was estimated at 15 g/kg bw. At this dosage bone marrow smears showed a reduced number of polychromatic erythrocytes (PCE) as compared with normochromatic erythrocytes (NCE). At a dose exceeding 15 g/kg bw the mortality was too high.
DETAILS OF SLIDE PREPARATION: Immediately after sacrifice, femurs of a mouse were dissected free of muscle, and by a 1 mL syringe with needle the bone marrow was flushed out into 5 mL of fetal calf serum. After thorough shaking, the mixture was centrifuged for 10 min. at about 1000 rpm. Thereafter, smears were made after removal of the supernatant. The specimens were fixed in methanol and stained with May-Grunwald/Giemsa.
METHOD OF ANALYSIS: Prior to microscopic assessment, all slides were furnished with code numbers, so that the counting was blind. The following counts were made:
Number of normochromatic erythrocytes (NCE) per 1000 erythrocytes
Number of polychromatic erythrocytes (PCE) per 1000 erythrocytes
Number of micronuclei (MN) in 1000 normochromatic erythrocytes
Number of micronuclei (MN) in 1000 polychromatic erythrocytes.
- Evaluation criteria:
- Increase in the frequency of micronucleated polychromated erythrocytes in treated animals as compared to controls.
- Statistics:
- The statistical difference was analysed by one-way ANOVA. In the case of PCE (%) the test was performed on the values observed, and for the MN (per thousand) the test was done on computed rank values transformed to normal scores according to Blom's method. (G. Blom Statistical Estimates and Transformed Beta Variables. New York: John Wiley and Sons, Inc., 1958).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: Up to 15 g/kg bw
- Clinical signs of toxicity in test animals: Maximum tolerated dose was estimated at 15 g/kg bw. At a dose exceeding 15 g/kg bw, the mortality was too high.
- Evidence of cytotoxicity in tissue analyzed: At 15 g/kg bw, bone marrow smears showed a reduced number of polychromatic erythrocytes (PCE) as compared with normochromatic erythrocytes (NCE).
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): No significant difference as compared to controls.
- Appropriateness of dose levels and route: Yes
- Statistical evaluation: Yes
Any other information on results incl. tables
For detailed results and bar charts kindly refer to the attached background materials section of the IUCLID.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance did not induce an increase in the frequency of micronuclei in bone marrow cells of the mouse, and was therefore considered to be non-mutagenic.
- Executive summary:
A study was conducted to evaluate the in vivo genetic toxicity of the test substance, C8-18 and C18-unsatd. DEA, according to the method recommended in the First Addendum to OECD Guideline 474 and Method No. 431, Annex V of EEC Directive 79/831. The experimental animals were 70 NMRI mice, divided into 5 groups. Of the 5 groups, 3 were test groups, 1 negative control group and 1 positive control group. The test groups were treated with 15000 mg test substance/kg bw, the negative control group with distilled water and the positive control group with 30 mg cyclophosphamide/kg bw. The mice were killed 24, 48 and 72 h, respectively, after treatment. From bone marrow smears, micronucleus counts were made per 1000 polychromatic erythrocytes. The test substance did not induce an increase in the frequency of micronucleated normochromatic erythrocytes in peripheral blood samples from both male and female mice. Under the study conditions, the test substance did not induce an increase in the frequency of micronuclei in bone marrow cells of the mouse, and was therefore considered to be non-mutagenic (Kallesen, 1985).
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