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EC number: 253-760-2 | CAS number: 38051-10-4
- 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
- Study period:
- 18 September - 20 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- EC Number:
- 253-760-2
- EC Name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- Cas Number:
- 38051-10-4
- Molecular formula:
- C13H24Cl6O8P2
- IUPAC Name:
- 2,2-bis(chloromethyl)propane-1,3-diyl tetrakis(2-chloroethyl) bis(phosphate)
- Details on test material:
- Product name: Antiblaze V6
Appearance: clear pale yellow liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, l'Arbresle, France
- Age at study initiation: approximately 6 weeks
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: polycarbonate cages
- Diet: A04 C pelleted maintenance diet
- Water: Filtered , ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2
- Humidity (%): 30 - 70%
- Air changes (per hr): at least 12 cycles/hour
- Photoperiod (hrs dark/hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: Olive oil
- Amount of vehicle: 10 mL/kg
- Batch no: 010K6021 (Sigma, France) - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was suspended in the vehicle in oerder to achieve concentrations of 50, 100, 200 mg/mL for males and 43, 75, 87.5 and 175 mg/mL for females. The target doses were 500, 1000 and 2000 mg/kg bw for males and 437.5, 875 and 1750 mg/kg for females.
The dosing solutions were prepared immediately before use.
Volume of administration: 10 ml/kg bw.
- Frequency of treatment:
- Two treatments, seperated by 24 hours
- Post exposure period:
- 24 hours after last treatment (sampling time)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500, 1000, 2000 mg/kg/day (males)
Basis:
other: Target dose level
- Remarks:
- Doses / Concentrations:
437.5, 875, 1750 mg/kg/day (females)
Basis:
other: Target dose level
- No. of animals per sex per dose:
- 5 males and 5 females for controls and all dose levels, except for high dose level where 8 males and 8 females were used
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: Cyclophosphamide (CPA)
- Route of administration: oral, dissolved in distilled water
- Concentration: 5 mg/mL
-Dose: 50 mg/kg single dose
Examinations
- Tissues and cell types examined:
- Bone marrow, erythrocytes
- Details of tissue and slide preparation:
- Stain used: Giemsa
- Evaluation criteria:
- - Polychromatic erythrocytes (PE), normochromatic erythrocytes (NE) ratio established by scoring total of 1000 erythrocytes
- Number of micronucleated polychromatic erythrocytes (MPE) was counted in 2000 polychromatic erythrocytes
- Results considered positive if there is a statistically significant increase in the frequency of MPE compared to the concurrent vehicle control group - Statistics:
- - no significant within-group heterogeneity MPE values: Chi-square test
- significant within-group heterogeneity MPE values: Mann-Whitney test
- PE/NE ratio comparison: student "t"-test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Top dose-level determined in preliminary toxicity test
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In preliminary toxicity test, the test item was administered at 1500, 1750 and 2000 mg/kg/day (females) and 2000 mg/kg/day (males), to select the top dose level for the definitive test. For males no toxic effect was observed at 2000 mg/kg/day, this was selected as highest dose-level for the main test. For females 1/3 animals was found dead one h following a single dose of 2000 mg/kg bw. Clinical signs (half-closed eyes or hypoactivity) were observed after the first dose of 1750 mg/kg bw and 1750 and 1500 mg/kg/day in females and 1750 mg/kg was selected as highest dose level.
In the main test 1/5 of animals were found dead 24 hours after the first treatment in highest dose-level (2000 and 1750 mg/kg/day for males resp. females).
At the lower dose groups no clinical signs and mortality were observed. For both males and females, there were no significant differences between the MPE values of the treated groups compared to the control group.
In the males of the highest dose group a significant decrease in the PE/NE ratio was observed indicating that the bone marrow was reached. In otherdose levels the PE/NE ratio was not different from controls.
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No statistically significant difference in the number of micronucleated polychromatic erythroxcytes was observed between treated and control animals. The test substance does not induce damage to the chromosomes or the mitotic apparatus of mice bone marrow cells after two oral administrations at a 24-hour interval. - Executive summary:
In a Swiss Ico mouse bone marrow micronucleus assay, 5 males and 5 females per dose (8 animals for highest dose level) were treated orally with 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) at doses of 0, 500, 1000 and 2000 mg/kg/day (for males) and 0, 437.5, 875 and 1750 mg/kg/day (for females). The test item was administered twice, treatments seperated by 24 hours. Bone marrow cells were harvested 24 hours after last treatment. The vehicle used was olive oil.
There were signs of toxicity during the study, at the highest dose-level (mortality of 1/5 of animals). The PE/NE ratio was reduced in high dose male animals indicating that the bone marrow was reached. The test substance was tested at an adequate dose based on a preliminary toxicity test, where the highest dose-level for the main test was determined. The positive control (CPA) induced the appropriate response. No significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow was observed after any treatment time at any dose level.
This GLP study is classified as accepatble, it satisfies the requirements for OECD Test Guideline 474 for in vivo cytogenetic mutagenicity data.
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