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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 December 2009 - 1 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
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 TG (SMT, sumithion)
Brown liquid
Lot No.: 070502
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ORIENTBIO, Korea
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 173.3-217.8 g
- Fasting period before study: overnight (~16 hours)
- Housing: Individual
- Diet: ad libitum except prior to dosing
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3-22.4
- Humidity (%): 27.8-65.1
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 December 2009 To: 14 January 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was administered undiluted.
- Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 30 minutes, 1, 2, 4 and 6 hours after dosing and subsequently daily
- Frequency of weighing: Days 0, 1, 3, 7 and 14 (terminal)
- Necropsy of survivors performed: yes - Statistics:
- Not required
Results and discussion
- Preliminary study:
- No details
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two deaths occurred at 2000 mg/kg bw in the initial group of three females (Day 1 or 2). There was no mortality in either of the two groups of three females administered 300 mg/kg bw.
- Clinical signs:
- other: Clinical signs were observed in all rats at 2000 mg/kg bw and included reduced activity, lacrimation, salivation, tremor, chromaturia and perineal staining. All signs had resolved by Day 9. Signs at 300 mg/kg bw included perineal soiling, lacrimation, s
- Gross pathology:
- There were no treatment-related findings at necropsy.
Any other information on results incl. tables
Summary of mortality
Group |
Dose level (mg/kg bw) |
Number of rats |
Mortality |
1 |
2000 |
3F |
2/3 |
2 |
300 |
3F |
0/3 |
3 |
300 |
3F |
0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 of fenitrothion was found to be >300 -<2000 mg/kg bw;= fenitrothion therefore meets the criteria for classification for acute oral toxicity in Category 4 according to the CLP Regulation.
- Executive summary:
The acute oral toxicity of fenitrothion was investigated in an Acute Toxic Class study according to OECD 423. Three females were initally administered a dose of 2000 mg/kg bw and observed for 14 days. Due to mortality in this group, two additional groups of three females were administered 300 mg/kg bw in sequence, according to the study guideline. Two deaths occurred at 2000 mg/kg bw in the initial group of three females (Day 1 or 2). There was no mortality in either of the two groups of three females administered 300 mg/kg bw. Clinical signs were observed in all rats at 2000 mg/kg bw and included reduced activity, lacrimation, salivation, tremor, chromaturia and perineal staining; all signs had resolved by Day 9. Signs at 300 mg/kg bw included perineal soiling, lacrimation, salivation and tremor; all signs had resolved by Day 5. Transient slight reductions in bodyweight were seen in surviving animals of both dose groups. There were no treatment-related findings at necropsy. The acute oral LD50 of fenitrothion was found to be >300 -<2000 mg/kg bw; fenitrothion therefore meets the criteria for classification for acute oral toxicity in Category 4 according to the CLP Regulation.
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