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EC number: 255-255-2 | CAS number: 41198-08-7
- 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:
- 11 July 1989 to 19 February 1990
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Version / remarks:
- (1983)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- EC Number:
- 255-255-2
- EC Name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- Cas Number:
- 41198-08-7
- Molecular formula:
- C11H15BrClO3PS
- IUPAC Name:
- 4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: TRif: MAGF, SPF
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- single admin
- Frequency of treatment:
- once
- Post exposure period:
- 16, 24, 48hr (16hr data discounted and not report due to insufficient sample time)
Doses / concentrations
- Remarks:
- Doses / Concentrations:50, 100, 200 mg/kgBasis:nominal conc.
- No. of animals per sex per dose:
- 5 animals/sex/gp
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- Micronuclei within polychromatic erthyrocytes (PCE) analysed for endpoint assessment and PCE and normochromatic erthyrocyte cells analysed for toxicity assessment
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
RANGE-FINDING TEST:
Four males were dosed at 160, 200, 1000 and 5000 mg/kg. Animals were sacrificed at 3 days post the end of dosing. The following deaths were observed 0/4, 1/4, 4/4 and 4/4 respectively. The MTD was determined to be 160 mg/kg, however, in spite of the death observed a maximum dose of 200 mg/kg was selected for the micronucleus assay.
MICRONUCLEUS ASSAY
Five animals/sex/group were dosed using a dose volume of 20 mL/kg. Vehicle was 0.5% CMC.
Clinical observations:
No data reported
PCE ratio:
No evidence of cytotoxicity was observed.
Micronucleated polychromatic erythrocytes (MN PCE):
Analysis of the mean MN PCE group data from the first experiment indicated that there was no statistically significant increases MN PCE frequency compared to concurrent control values for either sex. Individual animal and group mean MN PCE frequencies were consistent with both the concurrent vehicle control values and the historical control. Positive control treatment induced the appropriate response
In the second experiment, whilst a significant increase (p<0.05) in MN PCE was observed for both male and female animals dosed at 50 mg/kg, this was due MNPCE values in both control groups being particularly low, with the increases not deemed biologically relevant. Furthermore, the slight increases observed were not accompanied by a decrease in %PCE values.
Table 7.6.2 -1: Summary of micronucleus results in male and female mice (24 and 48hr sample)
Dose group |
Sex |
Harvest time (h) |
Mean %MN PCE/1,000 PCE |
Mean %PCE |
Vehicle |
male |
24 |
0.08 |
47 |
female |
24 |
0.14 |
45 |
|
Vehicle |
male |
48 |
0.08 |
46 |
female |
48 |
0.00 |
45 |
|
200 |
male |
24 |
0.12 |
48 |
female |
24 |
0.08 |
39 |
|
200 |
male |
48 |
0.06 |
40 |
female |
48 |
0.16 |
38 |
|
CPA |
male |
24 |
1.80 |
44 |
female |
24 |
2.48 |
42 |
Table 7.6.2 -2: Summary of micronucleus results in male and female mice (48hr sample)
Dose group |
Sex |
Harvest time (h) |
Mean %MN PCE/1,000 PCE |
Mean %PCE |
Vehicle |
male |
48 |
0.02 |
45 |
female |
48 |
0.06 |
44 |
|
50 |
male |
48 |
0.12* |
49 |
female |
48 |
0.16* |
46 |
|
100 |
male |
48 |
0.08 |
45 |
female |
48 |
0.08 |
44 |
|
200 |
male |
48 |
0.14 |
46 |
female |
48 |
0.08 |
47 |
|
CPA |
male |
24 |
1.54* |
48 |
female |
24 |
0.88* |
46 |
# Vehicle control,0.5% CMC(20 mL/kg body weight); positive control, cyclophosphamide (64 mg/kg)
* p<0.05
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeBased on the results from this study CGA 15’324 tech did not exhibit in vivo mammalian genotoxicity in male or female mouse bone marrow cells when tested up to a dose of 200 mg/kg (considered to exceed the MTD).
- Executive summary:
In a bone marrow micronucleus assay usingTif: MAG., SPF mice, a single administered gavage dose of CGA 15'324 tech was administered to groups of male and female animals, employing a dose volume of 20 mL/kg. Doses were selected from a pilot toxicity study where four male mice were dosed at 160, 200, 1000 and 5000 mg/kg. The maximum tolerated dose was deemed to be 160 mg/kg, however, for an unexplained reason the maximum dose selected for the micronucleus assay was 200 mg/kg, with further doses of 50 and 100 mg/kg.
Negative control groups were treated with vehicle only (0.5% CMC), and positive control groups were treated with cyclophosphamide (CPA, 64 mg/kg). Mouse bone marrow was sampled at 24 and 48 hours after dosing for the vehicle, positive control and the highest dose group and again at 48hrs for the vehicle, positive control and all dose groups. A further sample time of 16 hours was also utilised, however as this sample time is considered too early, data from this sample time point has not been reported. Slides of bone marrow cells were prepared from five animals/sex/time point (where available) for each group and scored for the occurrence of micronucleated polychromatic erythrocytes (MN PCE) and PCE/total erythrocyte ratios.
One female dosed at 200 mg/kg died within the 48 hour treatment period (2nd sample time) died prior to the scheduled necropsy. There were no marked decreases in mean PCE/total erythrocyte ratio observed for any of the CGA 15’324 tech treated groups compared to the vehicle control group for either time points.
Analysis of the mean MN PCE group data from the first experiment indicated that there was no statistically significant increases MN PCE frequency compared to concurrent control values for either sex. Individual animal and group mean MN PCE frequencies were consistent with both the concurrent vehicle control values and the historical control. Positive control treatment induced the appropriate response
In the second experiment, whilst a significant increase (p<0.05) in MN PCE was observed for both male and female animals dosed at 50 mg/kg, this was due MNPCE values in both control groups being particularly low, with the increases not deemed biologically relevant. Furthermore, the slight increases observed were not accompanied by a decrease in %PCE values Positive control treatment induced the appropriate response.
Based on the results from this study CGA 15’324 techdid not exhibit in vivo mammalian genotoxicity in male or female mouse bone marrow cells when tested up to a dose of 200 mg/kg (considered to exceed the MTD).
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