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EC number: 430-500-8 | CAS number: 204277-61-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: other: clastogenicity/aneugenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 February 1999 to 22 March 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP methodology followed and the OECD Guideline for Testing of Chemicals, Section 4, No. 474, adopted July 21, 1997, "Mammalian Erythrocyte Micronucleus Test". used to performed the experiment.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- relative humidity was lower than 30 % (lowest value 21 %) and test article of two deliveries (S 160511 pre-experiments and S 160521 micronucleus test) were used.(These deviations had no influence on the integrity and validity of the study)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, CH-4414 Füllinsdorf
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Males mean value 32.6 g (SD +/- 2.7g); Females mean value 25.4 g (SD +/- 2.0 g)
- Assigned to test groups randomly: yes, the animals were distributed into the test groups at random and identified by cage number
- Fasting period before study: Approximately 18 hours before treatment the animals received no food but water ad libitum.
- Housing: Single
- Diet : pelleted standard diet, ad libitum (ALTROMIN 1324, D-32791 Lage/Lippe)
- Water (e.g. ad libitum): tap water, ad libitum, (Gemeindewerke, D-64380 Roßdorf)
- Acclimation period: The animals were under quarantine in the animal house of RCC - 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.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±3°C
- Humidity (%): relative humidity 21-46 %
- Photoperiod (hrs dark / hrs light): Artificial light 6.00 a.m. - 6.00 p.m. - Route of administration:
- oral: unspecified
- Vehicle:
- - Name: polyethylene glycol 400 (PEG 400)
- Supplier catalogue no. : MERCK KGaA, D-64293 Darmstadt 9726 (gas chromatography grade)
- Route and Frequency of Administration: orally, once
- Volume Administered: 10 ml/kg b.w. - Details on exposure:
- Test material. a single standard dose of 10ml/kg body weight oralls (200, 670 and 2000 mg/kg b.w.)
Vehicle control: Orally, once, 10ml/kg body weight-
Positive control: Orally, once, 40 mg/kg b.w. - Duration of treatment / exposure:
- 24 hours and 48 hours
- Frequency of treatment:
- Once
- Remarks:
- Doses / Concentrations:
200, 670 and 2000 mg/kg b.w.
Basis:
nominal conc. - No. of animals per sex per dose:
- Ten animals (5 males and 5 females) per test roup were evaluated.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Name: CPA; Cyclophosphamide
- Supplier: SIGMA-Aldrich Vertriebs-GmbH, D-82041 Deisenhofen
- Catalogue no.: 21.870-7 (purity: at least 98 %)
- Dissolved in: deionised water
- Dosing: 40 mg/kg b.w.
- Route and Frequency of Administration: orally, once
- Volume Administered: 10 ml/kg b.w.
Solution prepared on day of administration. The stability of CPA at room temperature is good. At 25°C only 3.5 % of its potency is lost after 24 hours - Tissues and cell types examined:
- Polychromatic erythrocytes
- Details of tissue and slide preparation:
- Preparation of the Animals:
The animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a syringe. The cell suspension was centrifuged at 1500 rpm (390 x g) 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-64293 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-79110 Freiburg). At least one slide was made
from each bone marrow sample. - Evaluation criteria:
- - A test article is classified as mutagenic if it induces either a dose-related increase in the number of micronucleated polychromatic erythrocytes or a statistically significant positive response for at least one of the test points.
- A test article producing neither a dose-related increase in the number of micronucleated polychromatic erythrocytes nor a statistically significant positive response at any of the test points is considered non-mutagenic in this system.
- - Statistics:
- Evaluation criteria can be confirmed by means of the nonparametric Mann-Whitney test.
However, both biological and statistical significance should be considered together. - Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- (did not induce micronuclei as determined by micronucleus test in the bone marrow cells of the mouse)
- Toxicity:
- yes
- Remarks:
- Slight toxicity at 500 and 2000 mg/kg b.w. (reduction of spontaneous activity)
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: Vehicle control (PEG 400) serves as negative control
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
FAT 41024/B, did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse. - Executive summary:
This study was performed to investigate the potential of FAT 41024/B to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse. This experiment was performed according to the OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) and follows GLP methodology.
The test article, FAT 41024/B, was formulated in polyethylene glycol 400 (PEG 400). PEG 400 was used as vehicle control. The volume administered orally was 10 ml/kg b.w.. 24 h and 48 h after a single administration of the test article the bone marrow cells were collected for micronuclei analysis.
Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 2000 polychromatic erythrocytes (PCEs) per animal were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test article the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCEs per 2000 PCEs.
The following dose levels of the test article were investigated:
- 24 h preparation interval: 200, 670, and 2000 mg/kg b.w..
- 48 h preparation interval: 2000 mg/kg b.w..
The highest dose (2000 mg/kg; maximum guideline-recommended dose) was estimated by a pre-experiment to be suitable.
After treatment with the test article the number of NCEs was not substantially increased as compared to the mean value of NCEs of the vehicle control thus indicating that FAT 41'024/B had no cytotoxic effectiveness in the bone marrow.
In comparison to the corresponding vehicle controls there was no statistically significant or biological relevant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test article and with any dose level used.
40 mg/kg b.w. cyclophosphamide administered per os was used as positive control which showed a substantial increase of induced micronucleus frequency.
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore, FAT 41024/B is considered to be non-mutagenic in this micronucleus assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Several mutagenicity studies have been conducted in in-vitro test systems which all turned out to be positive, (Ames test and Chromosome aberration test), except for the HPRT which is negative. This indicate clearly a mutagenic potential in-vitro.
One in-vivo mutagenicity assays was performed: Micronucleus Assay in Bone Marrow Cells of the Mouse and FAT 41024/B TE has no significant mutagenic potential in-vivo.
Altogether, it was judged that FAT 41024/B TE substance is mutagenic in vitro and not mutagenic in in-vivo experiment.
Justification for selection of genetic toxicity endpoint
A reliable bacterial reverse mutation test, in vitro chromosome aberration in Chinese hamster V79 cells test, V79/ HPRT test and in vivo
micronucleus test are available and were all performed according to OECD/EC guidelines.
All of these results are taken into consideration.
Justification for classification or non-classification
Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No. 1272/2008) and DSD (Directive 67/548/EEC).
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