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EC number: 406-940-1 | CAS number: 126019-82-7 DP 211
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 7, 1989 - October 16, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- 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)
- GLP compliance:
- yes
- Type of assay:
- other: micronucleus assay in vivo
Test material
- Reference substance name:
- O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
- EC Number:
- 406-940-1
- EC Name:
- O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
- Cas Number:
- 126019-82-7
- Molecular formula:
- C30-54H47-87O3PS
- IUPAC Name:
- O-2-(2-methylnonyl)phenyl O-4-(2-methylnonyl)phenyl O-2-(2-methyloctyl)phenyl phosphorothioate
- Details on test material:
- - Physical state: viscous liquid, insoluble in water; pH 7
- Storage condition of test material: room temperature
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Cricetulus griseus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Tierfarm, Sisseln, Switzerland
- Weight at study initiation: (tolerability test) females: 26-30 g, males: 26-33 g; (mutagenicity test) females: 24-33 g, males: 24-35 g
- Housing: induvidually caged
- Diet: standard diet (NAFAG No. 924)
- Water: ad libitum (tap water)
- Acclimation period: at least 3 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 43-49
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Arachis oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: no data
Maximum dosing volume: 10 mL/kg bw - Duration of treatment / exposure:
- The animals of the test group and the negative control group were sacrificed 16, 24 and 48 h after application.
- Frequency of treatment:
- single application
- Post exposure period:
- 16, 24 and 48 hours
Doses / concentrations
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 8/sex/dose/sacrifice time
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Cyclophosphamide in arachis oil
- Justification for choice of positive control: Applied dose yielded an average of 1.38 % polychromatic erythrocytes with micronuclei. This is significantly different from the controls (0.17 %) treated with the vehicle (arachis oil) alone.
- Route of administration: per os
- Doses / concentrations: 64 mg/kg bw cyclophosphamide
- Sacrificed: 24 h after administration
- Dosing volume: 10 mL/kg bw
- Vehicle: arachis oil
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: based on preliminary toxicity test
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Sacrifice time: 16, 24 and 48 h after treatment
DETAILS OF SLIDE PREPARATION:
Bone marrow is harvested from the shafts of both femurs with fetal calf serum. After centrifugation small drops of the sediment mixture are transferred on the end of a slide, spread out with the aid of a polished cover glass and the preparations are air-dried. Within 24 hours, the slides are stained in undiluted May-Gruenwald solution for 3 min then in May-Gruenwald solution/water 1/1 for 2 min. After being rinsed in distilled water, the slides are left immersed in diluted Giemsa solution (16.6%), for 10 min. After rinsing with distilled water and air-drying, the slides are cleared in Xylene and mounted.
METHOD OF ANALYSIS:
No. of animals: 5 sex/dose/sacrifice time
1000 polychromatic erythrocytes per animal each are scored for the incidence of micronuclei.
Cytotoxicity: (mitotic activity) ratio PCE/NCE, performed in 1000 erythrocytes - Evaluation criteria:
- A test substance is considered to be active in this test system if a statistically significant increase in the number of polychromatic erythrocytes with micronuclei in comparison with the negative control occurs at any sampling time.
- Statistics:
- The significance of difference is assessed by x²-test.
Results and discussion
Test results
- Key result
- 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:
- PRELIMINARY TOXICITY TEST:
- No. of animals/dose/sex: 2
- Doses: 5000, 1000, 200 mg/kg bw
- Result: no mortality or signs of toxicity were obseved up to 5000 mg/kg bw. Hence, 5000 mg/kg bw was determined as the highest applicable dose in the mutagenicity assay.
RESULTS OF DEFINITIVE STUDY: see attachment
Any other information on results incl. tables
There was no significant increase in the number of micronucleated polychromatic erythrocytes in the animals treated with the dose of 5000 mg/kg of test material as compared with the negative control animals at all three sampling times. By contrast, the positive control (cyclophosphamide, 64 mg/kg, sampling time 24 hours) yielded a marked increase of the percentage of micronucleated cells.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with the test item.
- Executive summary:
A GLP-compliant Mammalian Erythrocyte Micronucleus Test was performed folloing OECD guideline 474 to evaluate any mutagenic effect on polychromatic erythrocytes in bone marrow cells in vivo.In this study the animals were treated once with the highest applicable dose of 5000 mg/kg by gavagge and sacrificed 16, 24 and 48 hours thereafter. From the bone marrow smears were made. The bone marrow smears showed no statistically significant increase (p >0.05) in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals at all three sampling times. The respective "positive control" experiment with cyclophosphamide (64 mg/kg) yielded an average of 1.38 % polychromatic erythrocytes with micronuclei. This is significantly different from the controls (0.17 %) treated with the vehicle (arachis oil) alone. It is concluded that under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with the test item.
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