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EC number: 613-099-6 | CAS number: 62889-66-1
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Batch No: Batch 704/ tank 328 (ZST-Nr. 90/460)
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Tierfarm Fuellinsdorf, CH-4414 Fuellinsdorf/Basel, Switzerland
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: 30 g
- Fasting period before study: 18 h
- Housing: single, Makrolon Type I, with wire mesh top (Ehret GmbH, D-7830 Emmendingen 14)
- Diet: pelleted standard diet (Altromin 1324, D-4937 Lage/Lippe)
- Water: tap water ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Duration of treatment / exposure:
- 24-48-72 h
- Frequency of treatment:
- once
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
212.5; 425; 850 mg/kg for 24 h; 850 mg/kg bw additionally for 48-72 h
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Positive control(s):
- cyclophosphamide
- Route of administration: oral gavage
- Doses / concentrations: 30 mg/kg bw.
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
On the basis of pre-experiments doses below 1000 mg/kg b.w. of N-Tridecyldiisopropanolamin were estimated to be close to the maximum tolerated dose. Therefore 850 mg/kg bw were used as highest dose in the micronucleus assay.
DETAILS OF SLIDE PREPARATION:
The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a 5 ml syringe. The cell suspension was centrifuged at 1,500 rpm for 10 minutes and the supernatant was discarded. A small drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald (Merck, D-6100 Darmstadt)/ Giemsa (Gurr, BDH limited Poole, Great Britain). Cover slips were mounted with EUKITT (Kindler, D-7800 Freiburg). At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS:
Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. 1000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed as normochromatic erythrocytes per 1000 PCEs. The analysis was performed with coded slides.
- Statistics:
- Statistical significance at the five per cent level (p < 0 .05) was evaluated by means of the non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- In a series of pre-experiments and in the main test 850 mg/kg b.w. caused toxic reactions including mortality (2/18 females in the pre-test and 2/15 females in the main test)
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test group | dose mg/kg bw. | sampling time (h) | PECs with MN (%) | PCE/NCE |
Suspending agent | 0 | 24 | 0.11 | 1000/806 |
Test article | 212.5 | 24 | 0.12 | 1000/859 |
Test article | 425 | 24 | 0.13 | 1000/809 |
Test article | 850 | 24 | 0.15 | 1000/702 |
Cyclophosphamide | 30 | 24 | 2.13 | 1000/725 |
Suspending agent | 0 | 48 | 0.07 | 1000/827 |
Test article | 850 | 48 | 0.07 | 1000/817 |
Suspending agent | 0 | 72 | 0.08 | 1000/787 |
Test article | 850 | 72 | 0.13 | 1000/763 |
PCE= polychromatic erythrocytes
NCE = normochromatic erythrocytes
MN = micronuclei
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.
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.