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Diss Factsheets
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EC number: 400-910-1 | CAS number: 119822-74-1
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- ion
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 September 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Test material form:
- solid: particulate/powder
Test animals
- Species:
- mouse
- Strain:
- other: OF-1 albino mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA-CREDO, L'Arbresle, France
- Weight at study initiation: 25 g
- Assigned to test groups randomly: yes
- Housing: Animals were housed 5 of the same sex per cage in Makrolon type III cages
- Diet: Aliment Rats-Souris Charles River, produced by U.A.R., Villemoisson/Orge, France ad libitum
- Water: ad libitum
- Acclimation period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Details on exposure:
- A preliminary range finding test by treating three groups of three male mice at concentrations of 3000, 2000 and 1000 mg/kg were conducted. For the micronucleus test, each treatment group was comprised of five male and five female mice receiving one intragastric intubation (2500 mg/kg) using 0.5 ml of a solution at 125 mg/ml per 25 g body weight.
- Duration of treatment / exposure:
- 20, 44 and 68 h
- Frequency of treatment:
- single application
- Post exposure period:
- 20, 44 and 68 h for main test
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2500 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Thio-TEPA
Examinations
- Tissues and cell types examined:
- Two types of erythrocytes were observed in the bone marrow smears: normochromatic (mature red blood cells about to pass into the blood stream) and polychromatic (immature red blood cells) . The latter are stained blue by Giemsa for around 24 h after the expulsion of the erythroblast nucleus: the colouration is probably due to traces of RNA remaining in these cells.
- Details of tissue and slide preparation:
- After sacrifice of the animals the femurs were taken and broken open at one end. Bone marrow cells were suspended in foetal calf serum using a small syringe, and the cells were centrifuged at 120 x g for 5 minutes. The supernatant was removed with a Pasteur pipette, cells were spread on a microscope slide and the smears allowed to dry in air. The following day smears were stained with Giemsa (1:6 in water) and mounted after drying with a coverslip.
- Statistics:
- A complete statistical analysis, using BMPD computer programme 7D is performed.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- At low magnification of the microscope no noticeable differences in bone marrow nucleated cells were observed between animals treated with FAT 20'306/B and negative controls.
In the positive control group (Thio-TEPA) decreased numbers of bone marrow nucleated cells were noted.
Any other information on results incl. tables
There was no statistically significant increase in the number of micronucleated polychromatic erythrocytes in animals exposed to 2500 mg/kg of FAT 20306/B compared to negative control animals. In animals treated with Thio-TEPA there was a statistically significant increased number of micronucleated cells. The ratio of polychromatic to normochromatic erythrocytes was markedly decreased in mice treated with Thio-TEPA. There was no difference between animals treated with FAT 20306/B and the negative control for this ratio.
Applicant's summary and conclusion
- Conclusions:
- FAT 20306/B did not present a mutagenic effect in the micronucleus test using mice treated by oral administration at 2500 mg/kg.
- Executive summary:
The micronucleus test was performed to assess mutagenicity toxicity of the test article based on OECD 474. The test article was administered orally to mice at concentration of 2500 mg/kg body weight. There was no statistically significant increase in the number of micronucleated polychromatic erythrocytes in animals exposed to 2500 mg/kg of FAT 20306/B compared to negative control animals. In animals treated with Thio-TEPA there was a statistically significant increased number of micronucleated cells (pronounced evidence of mutagenicity 44 h after administration). The ratio of polychromatic to normochromatic erythrocytes was markedly decreased in mice treated with Thio-TEPA. There was no difference between animals treated with FAT 20306/B and the negative control for this ratio. Thus, we can conclude the test article dose not present a mutagenic effect to mice.
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