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EC number: 600-026-8 | CAS number: 1000817-22-0
- 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 and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- EC Number:
- 600-026-8
- Cas Number:
- 1000817-22-0
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- Details on test material:
- Identity: Kerocom FM 38
Batch No.: 2008250
Purity: mixture of reaction products
Aggregate State at Room Temperature: liquid
Colour: yellow to brownish, clear
Stability in solvent: stable for at least 4 h at room temperature in corn oil
Storage: at room temperature
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Acclimation: 7 days
Initial age at start of experiment: 8 - 12 weeks
Initial body weight at start of treatment: mean value 39.6 g (SD ± 3.0g)
The animals were under acclimation in the animal house of Harlan CCR for a minimum of five days after their arrival. During this period the animals did not show any signs of illness or altered behaviour.
The animals were distributed into the test groups at random and identified by cage number.
Housing: single
Cage Type: Makrolon Type II/III, with wire mesh top (EHRET GmbH, 79302 Emmendingen, Germany)
Bedding: granulated soft wood bedding (Rettenmaier & Söhne GmbH + Co. KG, 73494 Rosenberg, Germany)
Feed: pelleted standard diet, ad libitum (Harlan Laboratories GmbH, 33178 Borchen, Germany)
Water: tap water, ad libitum, (Gemeindewerke, 64380 Rossdorf, Germany)
Environment: temperature 22 + 2 °C; relative humidity 45 - 65 %; artificial light 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- once orally
- Frequency of treatment:
- once orally
Doses / concentrations
- Remarks:
- Doses / Concentrations:
24 h preparation interval: 500, 1000, and 2000 mg/kg b.w. 48 h preparation interval: 2000 mg/kg b.w.
Basis:
- No. of animals per sex per dose:
- Seven males per test group
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- bone marrow cells
- Details of tissue and slide preparation:
- It is generally recommended to use the maximum tolerated dose or the highest dose that can be formulated and administered reproducibly or 2000 mg/kg as the upper limit for non-toxic test items.
The maximum tolerated dose level is determined to be the dose that causes toxic reactions without having major effects on survival within 48 hours.
Since no gender specific differences concerning signs of toxicity in the pre-experiment were observed, the main study was performed using males only.
The administered volume was 10 ml/kg b.w.
Three adequately spaced dose levels spaced by a factor of 2 were administered, and samples were collected at the central sampling interval 24 h after treatment. For the highest dose level an additional sample was taken at 48 h after treatment.
Sampling of the bone marrow was done 24 and 48 hours after treatment, respectively. - Evaluation criteria:
- A test item is classified as mutagenic if it induces either a dose-related increase or a clear increase in the number of micronucleated polychromatic erythrocytes in a single dose group. Statistical methods (nonparametric Mann-Whitney test [8] are used as an aid in evaluating the results, if necessary. However, the primary point of consideration is the biological relevance of the results. A test item that fails to produce a biological relevant increase in the number of micronucleated polychromatic erythrocytes is considered non-mutagenic in this system.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- After treatment with the test item the number of PCEs was not substantially decreased as compared to the mean value of PCEs of the vehicle control thus indicating that Kerocom FM 38 did not exert any cytotoxic effects in the bone marrow.
In comparison to the corresponding vehicle controls there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used.
40 mg/kg b.w. cyclophosphamide administered orally was used as positive control which showed a substantial increase of induced micronucleus frequency.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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