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EC number: 204-524-2 | CAS number: 122-14-5
- 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:
- weight of evidence
- Study period:
- 23 March 1982 - 14 April 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Fenitrothion
- EC Number:
- 204-524-2
- EC Name:
- Fenitrothion
- Cas Number:
- 122-14-5
- Molecular formula:
- C9H12NO5PS
- IUPAC Name:
- O,O-dimethyl O-3-methyl-4-nitrophenyl phosphorothioate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Fenitrothion
Batch No.: 00106
Purity: 96.8%
Test animals
- Species:
- mouse
- Strain:
- ICR
- Details on species / strain selection:
- Standard species/strain used for regulatory studies
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals (Japan)
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 33-45 g
- Diet: ad libitum)
- Water: e.g. ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-25
- Humidity (%): 50-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12-12
IN-LIFE DATES: From: 23 March 1982 To: 14 April 1982
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Corn oil
- Details on exposure:
- Groups of 6 male ICR mice (7 to 8 weeks old) each received a single intraperitoneal injection of fenitrothion in corn oil at dose levels of 200, 400, 800 and 1600 mg/kg bw (10 mL kg/bw)
- Duration of treatment / exposure:
- Single intraperitoneal injection
- Frequency of treatment:
- Single intraperitoneal injection
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Vehicle (corn oil) control
- Dose / conc.:
- 200 mg/kg bw/day
- Remarks:
- Single intraperitoneal injection
- Dose / conc.:
- 400 mg/kg bw/day
- Remarks:
- Single intraperitoneal injection
- Dose / conc.:
- 800 mg/kg bw/day
- Remarks:
- Single intraperitoneal injection
- Dose / conc.:
- 1 600 mg/kg bw/day
- Remarks:
- Single intraperitoneal injection
- No. of animals per sex per dose:
- 6 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C, 4 mg/kg bw
Examinations
- Tissues and cell types examined:
- Polychromatic bone marrow erythrocytes
- Details of tissue and slide preparation:
- Mice were sacrificed 24 hours after administration. Bone marrow cells were obtained from a femur, fixed, stained (Giemsa) and analyzed in a blind manner. A thousand erythrocytes were observed and the incidence of micronucleated cells as well as the ratio of polychromatic erythrocytes to whole erythrocytes were examined from each animal. The micronucleated cells in 1000 polychromatic erythrocytes were also counted
- Evaluation criteria:
- Not reported
- Statistics:
- The incidence of micronucleated cells was assessed according to Kastenbaum & Bowman; the t-test was used for assessment of the PCE:NCE ratio.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Mortality at 1600 mg/kg bw; altered PCE ratio at 800 mg/kg bw
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- All mice administered 1600 mg/kg bw fenitrothion died before scheduled sacrifice.
Any other information on results incl. tables
Summary of findings
Treatment |
Dose level (mg/kg bw) |
Time |
No. mice |
No. cells |
PCEs (%) |
Micronucleated erythrocytes (%) |
Micronucleated PCEs (%) |
Corn oil |
10 ml/kg |
24h |
6 |
6000 |
30.9 |
0.08 |
0.18 |
Fenitrothion |
200 |
24h |
6 |
6000 |
36.0 |
0.25* |
0.25 |
400 |
24h |
6 |
6000 |
36.8 |
0.10 |
0.17 |
|
800 |
24h |
6 |
6000 |
44.4** |
0.18 |
0.30 |
|
MMC |
4 |
24h |
6 |
6000 |
31.0 |
1.45** |
4.75** |
**significantly different to controls (p<0.01)
PCE: polychromatic erythrocyte
Applicant's summary and conclusion
- Conclusions:
- Fenitrothion did not induce micronuclei in the bone marrow cells of mice under the conditions of this study.
- Executive summary:
In a mouse bone marrow micronucleus assay, groups of 6 male ICR mice (7 to 8 weeks old) each received a single intraperitoneal injection of fenitrothion in corn oil at dose levels of 200, 400, 800 and 1600 mg/kg bw (10 mL/kg bw). All animals at 1600 mg/kg bw died before the scheduled sacrifice. Mice were sacrificed 24 hours after administration. Bone marrow cells were obtained from a femur, fixed, stained (Giemsa) and analysed in a blind manner. A thousand erythrocytes were observed and the incidence of micronucleated cells as well as the ratio of polychromatic erythrocytes to whole erythrocytes were examined from each animal. The micronucleated cells in 1000 polychromatic erythrocytes were also counted. Negative controls (corn oil) and positive controls (mitomycin C 4 mg/kg bw; 10 mL/kg bw) were similarly assessed. All mice administered 1600 mg/kg bw fenitrothion died before scheduled sacrifice. A significantly increased PCE ratio in mice at 800 mg/kg bw indicated adequate exposure of the target tissue. A statistically significant increase in the incidence of micronucleated PCEs was seen in the low dose group, but is not considered to be of biological relevance in the absence of similar findings in the other dose groups. The PCE ratio was significantly increased in the high dsoe group, indicating exposure of the target tissue. Fenitrothion did not induce micronuclei in the bone marrow cells of mice under the conditions of this study.
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