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EC number: 257-913-4 | CAS number: 52434-90-9
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1980
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Significant deficiencies from current Guideline, e.g. samples were taken 6 hours after the last dose.
- GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 257-913-4
- EC Name:
- 1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 52434-90-9
- Molecular formula:
- C12H15Br6N3O3
- IUPAC Name:
- tris(2,3-dibromopropyl)-1,3,5-triazinane-2,4,6-trione
- Reference substance name:
- unknown impurities
- IUPAC Name:
- unknown impurities
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Test material: Interstab FR 930
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Adult male and female mice, strain CD-1, from a randomly bred closed colony were purchased from Charles River Breeding Laboratories, Inc., Wilmington, MA. This healthy, random-bred strain has been selected to maximize genetic heterogeneity and at the same time assure access to a common source.
Animals were group-housed up to 15 mice per cage. A commercial diet (Purina Laboratory Chow) and water were offered ad libitum unless contraindicated by the particular experimental design.
Thirty-two outbred mice, 4 males and 4 females per dose level, were used. Animals were assigned to study groups at random according to Litton Bionetics, Inc. (LBI) Standard Operating Procedures (SOP). Prior to study initiation, animals were weighed to calculate dose levels according to SOP “Animal Weight Determinazion.” The volume of test article administrered per animal was established using this method unless there was significant variation among individuals, in which case individual calculations were made. Animals were uniquely identified by ear tag or ear punch. Dose or treatment groups were identified by cage card.
Sanitary cages and bedding was used. Personnel handling animals or working within the animal facilities were required to wear suitable protective garments. When appropriate, individuals with respiratory or other overt infections were excluded from the animal facilities.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Duration of treatment / exposure:
- A subchronic dosing regimen was used. It consisted of two administrations approximately 24 hours apart. Treatment covered a 30-hour period or two cell cycles.
- Frequency of treatment:
- 24h/dose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 000 mg/kg bw/day (actual dose received)
- Remarks:
- highest dose, FR 930
- Dose / conc.:
- 1 250 mg/kg bw/day (actual dose received)
- Remarks:
- lowest dose, FR930
- No. of animals per sex per dose:
- 4 males and 4 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylenemelamine (TEM) at 1.0 mg/kg was dissolved in saline and used as the positive control article and was administered via a split dose intraperitoneal (IP) injection. The maximum amount administered to the experimental animals was 0.25 ml per male mouse and 0.20 ml per female mouse.
Examinations
- Tissues and cell types examined:
- Mouse Bone Marrow
- Details of tissue and slide preparation:
- EXTRACTION OF BONE MARROW
Six hours after the last dose, animals were killed with CO2 and the adhering soft tissue and epiphyses of both tibia were removed. The marrow was aspirated from the bone and transferred to centrifuge tubes containing 5 ml fetal calf serum (one tube for each animal).
PREPARATION OF SLIDES
Following centrifugation to pellet the tissue, the supernatant was drawn off, cells resuspended in a drop of serum, and suspension spread on slides and air dried. The slides were then fixed in methanol, stained in May-Gruenwald solution followed by Giemsa, and rinsed in deionized water (Schmid, 1975).
SCREENING THE SLIDES
A thousand PCE’s per animal were scored. The frequency of micronucleated cells was expressed as percent micronucleated cells based on the total PCE’s present in the scored optic field. The normal frequency of micronuclei in this mouse strain in between 0.3 and 0.4%. - Evaluation criteria:
- In tests performed for this evaluation only PCE’s were scored for micronuclei. Mature erythrocytes and other cells in the field were noted but not scored.
Two dose levels were established to ensure that a nontoxic level of the test article was scored. Dose response data are not necessary to define a test article as active. Responses considered positive are assumed to reflect clastogenic and related activities of test articles. Agents which break chromosomes and induce nondisjunction and other events which produce structural or numerical changes in chromosomes can produce micronuclei.
The data were analyzed by a student t-test (Brancroft 1957). Individual animal results were used as data points in the analysis. The set of micronuclei frequencies among the controls was compared to the set for each treatment level. Male and female animal data were analyzed separately and combined. Increases above the negative control frequency that are significant at p < 0.01 are considered indicative of an active agent.
For control of bias, all slides were coded prior to scoring and scored blind.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: did not induce micronuclei at the doses tested
- Additional information on results:
- The test material, Interstab FR930 is evaluated here for its ability to induce micronuclei in polychromatic erythrocytes (PCE, i.e. immature red blood cells) in mouse bone marrow.
The frequency of micronuclei in marrow from the negative control animals is within the normal range for this laboratory. The positive control compound, triethylenemelamine (TEM) induced a large increase in micronuclei, to a total of about 7%. There is no evidence for induction of micronuclei by the test compound.
Further details on results are present in the attache full study report.
Applicant's summary and conclusion
- Conclusions:
- The test item Interstab FR930 did not induce micronuclei at the doses tested.
- Executive summary:
The objective of this study was to evaluate the test article for clastogenic activity in polychromatic erythrocyte (PCE) stem cells in treated mice.
Adult male and female mice, strain CD-1, healthy and random-bred strain have been selected to maximize genetic heterogeneity and at the same time assure access to a common source.
Thirty-two outbred mice, 4 males and 4 females per dose level, were used. Prior to study initiation, animals were weighed to calculate dose levels according to SOP “Animal Weight Determinazion.” The volume of test article administrered per animal was established using this method unless there was significant variation among individuals, in which case individual calculations were made.
The route of administration was oral gavage, the most common route of administration for this test procedure. A subchronic dosing regimen was used: it consisted of two administrations approximately 24 hours apart. Treatment covered a 30-hour period or two cell cycles. Stock solutions of the test compound were prepared in dimethylsulfoxide (DMSO) at initial concentrations of 800 mg/ml and 100 mg/ml for administering the high (5 g/kg/day) and low (0.63 g/kg/day) doses respectively. The total doses were 10 g/Kg (highest dose) and 1.25 g/kg (lowest dose).
The negative control article was administered by the same route as, and concurrently with, the test article and in volumes equal to the maximum amount administered to the experimental animals (0.25 ml per male mouse and 0.20 ml per female mouse).
Triethylenemelamine (TEM) at 1.0 mg/kg was dissolved in saline and used as the positive control article and was administered via a split dose intraperitoneal (IP) injection.
The frequency of micronuclei in mouse bone marrow from the negative control animals is within the normal range for this laboratory.
The positive control compound, triethylenemelamine (TEM) induced a large increase in micronuclei, to a total of about 7%.
There is no evidence for induction of micronuclei by the test compound.
In conclusion, the test item did not induce micronuclei at the doses tested.
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