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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
Endpoint summary
Administrative data
Description of key information
Studies of acute oral, inhalation and dermal toxicity are available for fenitrothion.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- Specific details on test material used for the study:
- Fenitrothion TG (SMT, sumithion)
Brown liquid
Lot No.: 070502 - 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 - 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
- Preliminary study:
- No details
- 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.
- 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.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- August 1, 1972 - September 30, 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- In-house method, comparable to OECD 401
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Fenitrothion
Batch No.: 417
Purity: 97.2% - Species:
- mouse
- Strain:
- other: dd
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 10% Tween-80
- Details on oral exposure:
- Fenitrothion was suspended in 10% Tween-80 and administered orally to groups of 8 male and 8 female dd mice at dose levels of of 0 (vehicle), 500, 700, 980, 1370, 1920 mg/kg bw using a constant dose volume of 20 mL/kg bw.
- Doses:
- 0 (vehicle), 500, 700, 980, 1370, 1920 mg/kg bw
- No. of animals per sex per dose:
- 8
- Control animals:
- yes
- Remarks:
- Vehicle control
- Details on study design:
- Mortality and signs of toxicity were observed for 7 days
- Statistics:
- Not required
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 030 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 040 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Deaths occurred at dose levels of >=700 mg/kg bw in males and females. Most deaths occurred within 24 hours of dosing.
- Clinical signs:
- other: Clinical signs including reduced spontaneous activity, dyspnoea, ataxia and lacrimation were observed from 30 minutes after dosing with 700 mg/kg bw. At higher dose levels, irregular respiration, salivation, slight tremor and clonic convulsion were also
- Gross pathology:
- No data
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- LD50 values of 1030 and 1040 mg/kg bw were calculated for males and females, respectively. Classification for acute oral toxicity under CLP is assigned on the basis of data in the rat.
- Executive summary:
The acute oral toxicity of fenitrothion was investigated in the mouse. Groups of eight male and female dd mice were gavaged with fenitrothion (suspended in 10% Tween 80) at dose levels of 0 (vehicle), 500, 700, 980, 1370 or 1920 mg/kg bw, using a constant dose volume of 20 mL/kg bw. Mice were observed for 7 days after dosing. Deaths occurred at dose levels of >=700 mg/kg bw in males and females. Most deaths occurred within 24 hours of dosing. Clinical signs including reduced spontaneous activity, dyspnoea, ataxia and lacrimation were observed from 30 minutes after dosing with 700 mg/kg bw. At higher dose levels, irregular respiration, salivation, slight tremor and clonic convulsion were also observed. LD50 values of 1030 and 1040 mg/kg bw were calculated for males and females, respectively.
Referenceopen allclose all
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 |
Summary of mortality
Males |
Females |
||||
Dose level (mg/kg bw) |
Mortality |
Time of death |
Dose level (mg/kg bw) |
Mortality |
Time of death |
500 |
0/8 |
- |
500 |
0/8 |
- |
700 |
1/8 |
Day 1 (1) |
700 |
1/8 |
Day 1 (1) |
980 |
4/8 |
Day 1 (4) |
980 |
3/8 |
Day 1 (3) |
1370 |
6/8 |
Day 1 (6) |
1370 |
6/8 |
Day 1 (5), Day 2 (1) |
1920 |
8/8 |
Day 1 (8) |
1920 |
8/8 |
Day 1 (5), Day 2 (3) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- A modern, GLP- and guideline-compliant study is available for fenitrothion and is supported by older data.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 January 1985 - 20 March 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- no
- Specific details on test material used for the study:
- Fenitrothion
Batch No.: 40805
Purity: 96.6% - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Nominal concentration of the test material in the chamber air (mg/m3)
Group I: vehicle only (vehicle control)
Group II: vehicle only (negative control)
Group III: 6.57
Group IV: 16.4
Group V: 65.7
Group VI: 1640
Group VII: 3280
Mean concentration measured (mg/m3)
Group III: 3.91
Group IV: 8.90
Group V: 38.2
Group VI: 1,010
Group VII: 2,210
Median aerodynamic diameter: 0.59 to 0.82 µm
Chamber air temperature: 28.4 to 30.8 °C
Relative humidity: 59.8 to 90.3 % - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: corn oil
- Mass median aerodynamic diameter (MMAD):
- >= 0.59 - <= 0.82 µm
- Remark on MMAD/GSD:
- Particle size adequately small: in the respirable range
- Details on inhalation exposure:
- Fenitrothion was dissolved in corn oil and administered by inhalation of a test atmosphere containing dust generated from the test substance; single administration, 4-hour whole body exposure.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Remarks on duration:
- Standard exposure period
- Concentrations:
- Mean measured concentrations were 3.91, 8.90, 38.2, 1010 and 2210 mg/m3.
- No. of animals per sex per dose:
- 20/sex: each group had a main group for general observation, body weight, cholinesterase activity and pathological examination, and a satellite group for assessment of cholinesterase activity only.
- Control animals:
- yes
- Remarks:
- Two control groups; control and non-exposed
- Details on study design:
- Fenitrothion was dissolved in corn oil and administered by inhalation of a test atmosphere containing dust generated from the test substance; single administration, 4-hour whole body exposure, two control groups (vehicle and negative controls) and five test groups of Sprague-Dawley rats. Each exposure group had a main group for general observation, body weight, cholinesterase activity and pathological examination, and a satellite group for assessment of cholinesterase activity only.
- Statistics:
- Not required
- Preliminary study:
- Not reported
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2 210 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One male exposed to 2210 mg/m3 died on Day 6. There were no further mortalities.
- Clinical signs:
- other: Irregular respiration, hyperpnoea, nasal discharge, muscular fibrillation, intermittent tremors, reduced spontaneous activity, lacrimation, salivation and urinary incontinence were observed in both sexes at >= 1010 mg/m3 and above. Males also showed exci
- Body weight:
- Slight transient reductions in body weight or weight gain was seen at >=1010 mg/m3.
- Gross pathology:
- Necropsy did not reveal any effects of treatment.
- Other findings:
- Inhibition of cholinesterase activity was observed 1-7 days after exposure. Plasma cholinesterase activity was reduced in males and females exposed to >=8.90 mg/m3; erythrocyte cholinesterase activity was reduced in males of groups exposed to >=1010 mg/m3 and in females exposed to >= 38.2 mg/m3. Brain cholinesterase activity was reduced in males and females exposed to >= 1010 mg/m3.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute inhalation LC50 of fenitrothion was found to be >2.21 mg/L (reported to be the maximum attainable concentration). Classification for acute inhalation toxicity is not required according to CLP criteria.
- Executive summary:
The acute inhalation toxicity of fenitrothion was investigated in a study in the rat. Groups of Sprague-Dawley rats (20/sex) were exposed for four hours (whole body) to mean measured concentrations of 3.91, 8.90, 38.2, 1010 and 2210 mg/m3 (MMAD 0.59 -0.82 um). One male exposed to 2210 mg/m3 died on Day 6. There were no further mortalities. Irregular respiration, hyperpnoea, nasal discharge, muscular fibrillation, intermittent tremors, reduced spontaneous activity, lacrimation, salivation and urinary incontinence were observed in both sexes at >= 1010 mg/m3 and above. Males also showed excitation, tonic convulsion, ataxia and soft faeces. Signs of toxicity were observed from 30 minutes after the initiation of exposure and resolved within 9 days of exposure in surviving rats. Slight transient reductions in body weight or weight gain was seen at >=1010 mg/m3. Inhibition of cholinesterase activity was observed 1-7 days after exposure. Plasma cholinesterase activity was reduced in males and females exposed to >=8.90 mg/m3; erythrocyte cholinesterase activity was reduced in males of groups exposed to >=1010 mg/m3 and in females exposed to >= 38.2 mg/m3. Brain cholinesterase activity was reduced in males and females exposed to >= 1010 mg/m3. Gross necropsy did not reveal any effects of treatment. The acute inhalation LC50 of fenitrothion was found to be >2210 mg/m3 (>2.21 mg/L; reported to be the maximum attainable concentration). Classification for acute inhalation toxicity is not required according to CLP criteria.
Reference
Summary of mortality
Exposure level
|
Males |
Females |
||
Cumulative Mortality |
Time of death |
Cumulative Mortality |
Time of death |
|
3.91 mg/m3 |
0 |
- |
0 |
- |
8.90 mg/m3 |
0 |
- |
0 |
- |
38.2 mg/m3 |
0 |
- |
0 |
- |
1010 mg/m3 |
0 |
- |
0 |
- |
2210 mg/m3 |
1 |
Day 6 (1) |
0 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 210 mg/m³ air
- Quality of whole database:
- A modern, GLP- and guideline-compliant study is available for fenitrothion.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- August 1, 1972 - September 30, 1972
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In-house method
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Fenitrothion
Batch No.: 417
Purity: 97.2% - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Fenitrothion was applied without any vehicle to 9 cm2 of the dorsal area of Sprague-Dawley rats (groups of 8 males and 8 females) at dose levels of 310, 625, 1250, 2500 and 5000 mg/kg bw.
- Duration of exposure:
- No details
- Doses:
- 310, 625, 1250, 2500 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 8
- Control animals:
- not required
- Details on study design:
- Animals were observed for 21 days for mortality and clinical signs.
- Statistics:
- Not required
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 890 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Deaths occurred in both sexes at dose levels of >=625 mg/kg bw; within 2 to 10 days.
- Clinical signs:
- other: At 310 mg/kg bw, clinical signs were limited to slight hyperexcitability. At 625 mg/kg bw, urinary incontinence, muscular twitch, rapid respiration, hyperexcitability and exophthalmus were observed, and were more severe at >=1250 mg/kg bw.
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Not sufficiently reliable
- Conclusions:
- The acute dermal LD50 of fenitrothion was calculated to be 890 and 1200 mg/kg bw in males and females, respectively.
- Executive summary:
In a non-guideline acute dermal toxicity study, Fenitrothion was applied without any vehicle to 9 cm2 of the dorsal area of Sprague-Dawley rats (groups of 8 males and 8 females) at dose levels of 310, 625, 1250, 2500 and 5000 mg/kg bw. Animals were observed for 21 days for mortality and clinical signs. Deaths occurred in both sexes at dose levels of >=625 mg/kg bw; within 2 to 10 days. At 310 mg/kg bw, clinical signs were limited to slight hyperexcitability. At 625 mg/kg bw, urinary incontinence, muscular twitch, rapid respiration, hyperexcitability and exophthalmus were observed, and were more severe at >=1250 mg/kg bw. The acute dermal LD50 of fenitrothion was calculated to be 890 and 1200 mg/kg bw in males and females, respectively. Due to deficiencies in reporting, the study is not considered to be sufficiently reliable as a basis for classification.
- Endpoint:
- acute toxicity: dermal
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Fenitrothion TG (SMT, sumithion)
Brown liquid
Lot no.: 070502 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/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: 8-9 weeks
- Weight at study initiation: 280.8-303.3 g (M); 224.8 - 247.9 g (F)
- Fasting period before study: No
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2-22.4
- Humidity (%): 27.8-65.1
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 Dec 2009 To: 5 Jan 2010 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 x 6 cm
- Type of wrap if used: Gauze, plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2000 mg/kg bw (undiluted) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 30 minutes, 1, 2, 4 and 6 hours on the day of dosingand daily thereafter
- Frequency of weighing: Days 0, 1, 3, 7 and 14 (terminal)
- Necropsy of survivors performed: yes - Statistics:
- None
- Preliminary study:
- Not reported
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred
- Clinical signs:
- other: There were no signs of toxicity
- Gross pathology:
- Necropsy did not reveal any effects of treatment
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of fenitrothion was found to be >2000 mg/kg bw. Fenitrothion does not therefore require classification for acute dermal toxicity according to the CLP Criteria.
- Executive summary:
The acute dermal toxicity of fenitrothion was investigated in a study in the rat, performed in compliance with OECD 402. Groups of rats were exposed to fenitrothion for 24 hours under occlusive conditions at dose levels of 0 (control) or 2000 mg/kg bw and observed for 14 days. There was no mortality in this study and no signs of systemic toxicity or local irritation. Bodyweights were unaffected by treatment and gross necropsy did not reveal any effects. The acute dermal LD50 of fenitrothion was therefore found to be >2000 mg/kg bw under the conditions of this study. Fenitrothion does not therefore require classification for acute dermal toxicity according to the CLP Criteria.
Referenceopen allclose all
Summary of mortality
Males |
Females |
||||
Dose level (mg/kg bw) |
Mortality |
Time of death |
Dose level (mg/kg bw) |
Mortality |
Time of death |
310 |
0/8 |
- |
310 |
0/8 |
- |
625 |
1/8 |
Day 6 (1) |
625 |
1/8 |
Day 5 ( 1) |
1250 |
7/8 |
Day 3 (1), Day 4 (1), Day 5 (2) Day 6 (2), Day 10 (1) |
1250 |
5/8 |
Day 2 (1), Day 3 (1), Day 4 (1) Day 6 (2) |
2500 |
8/8 |
Day 3 (2), Day 5 (2), Day 6 (1) Day 8 (1), Day 10 (2) |
2500 |
7/8 |
Day 2 (2), Day 3 (1), Day 4 (2) Day 6 (2) |
5000 |
8/8 |
Day 2 (2), Day 3 (2), Day 4 (4) |
5000 |
8/8 |
Day 2 (2), Day 3 (2), Day 4 (3), Day 5 (1) |
Summary of mortality
Dose level (mg/kg bw) |
Number of rats |
Mortality |
0 |
5M / 5F |
- |
2000 |
5M / 5F |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A modern, GLP- and guideline-compliant study is available for fenitrothion. An older study is available but is not considered to be reliable due to methodological limitations.
Additional information
Acute oral toxicity
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.
The acute oral toxicity of fenitrothion was investigated in a further study in the rat. Groups of eight male and female Sprague-Dawley rats were gavaged with fenitrothion (suspended in 10% Tween 80) at dose levels of0 (vehicle), 52, 73, 102, 143 (males only), 200, 280, 392, 550, 770, 1080 (females only) and 1510 (females only) mg/kg bw, using a constant dose volume of 10 mL/kg bw. Rats were observed for 7 days after dosing.Deaths occurred at dose levels of >=200 mg/kg bw in males and >=392 mg/kg bw in females. Most deaths occurred within 24 hours of dosing. Clinical signs including muscular twitch, tremor, ataxia, dacryohaemorrhoea, salivation, exophthalmus and urinary incontinence developed from 10-30 minutes after dosing at 72-102 mg/kg bw. Clinical signs increased in severity at higher dose levels. Recovery of surviving females was slower compared to males. LD50 values of 330 and 800 mg/kg bw were calculated for males and females, respectively. Fenitrothion is therefore classified in Category 4 for acute oral toxicity according to the CLP Criteria.
The acute oral toxicity of fenitrothion was investigated in a study in the mouse. Groups of eight male and female dd mice were gavaged with fenitrothion (suspended in 10% Tween 80) at dose levels of0 (vehicle), 500, 700, 980, 1370 or 1920 mg/kg bw, using a constant dose volume of 20 mL/kg bw. Mice were observed for 7 days after dosing.Deaths occurred at dose levels of >=700 mg/kg bw in males and females. Most deaths occurred within 24 hours of dosing. Clinical signs including reduced spontaneous activity, dyspnoea, ataxia and lacrimation were observed from 30 minutes after dosing with 700 mg/kg bw. At higher dose levels, irregular respiration, salivation, slight tremor and clonic convulsion were also observed. LD50 values of 1030 and 1040 mg/kg bw were calculated for males and females, respectively.
Acute inhalation toxicity
The acute inhalation toxicity of fenitrothion was investigated in a study in the rat. Groups of Sprague-Dawley rats (20/sex) were exposed for four hours (whole body) to mean measured concentrations of 3.91, 8.90, 38.2, 1010 and 2210 mg/m3 (MMAD 0.59 -0.82 um). One male exposed to 2210 mg/m3 died on Day 6. There were no further mortalities. Irregular respiration, hyperpnoea, nasal discharge, muscular fibrillation, intermittent tremors, reduced spontaneous activity, lacrimation, salivation and urinary incontinence were observed in both sexes at >= 1010 mg/m3 and above. Males also showed excitation, tonic convulsion, ataxia and soft faeces. Signs of toxicity were observed from 30 minutes after the initiation of exposure and resolved within 9 days of exposure in surviving rats. Slight transient reductions in body weight or weight gain was seen at >=1010 mg/m3. Inhibition of cholinesterase activity was observed 1-7 days after exposure. Plasma cholinesterase activity was reduced in males and females exposed to >=8.90 mg/m3; erythrocyte cholinesterase activity was reduced in males of groups exposed to >=1010 mg/m3 and in females exposed to >= 38.2 mg/m3. Brain cholinesterase activity was reduced in males and females exposed to >= 1010 mg/m3. Gross necropsy did not reveal any effects of treatment. The acute inhalation LC50 of fenitrothion was found to be >2210 mg/m3 (>2.21 mg/L; reported to be the maximum attainable concentration). Classification for acute inhalation toxicity is not required according to CLP criteria.
Acute dermal toxicity
The acute dermal toxicity of fenitrothion was investigated in a study in the rat, performed in compliance with OECD 402. Groups of rats were exposed to fenitrothion for 24 hours under occlusive conditions at dose levels of 0 (control) or 2000 mg/kg bw and observed for 14 days. There was no mortality in this study and no signs of systemic toxicity or local irritation. Bodyweights were unaffected by treatment and gross necropsy did not reveal any effects. The acute dermal LD50 of fenitrothion was therefore found to be >2000 mg/kg bw under the conditions of this study. Fenitrothion does not therefore require classification for acute dermal toxicity according to the CLP Criteria.
In a non-guideline acute dermal toxicity study, Fenitrothion was applied without any vehicle to 9 cm2 of the dorsal area of Sprague-Dawley rats (groups of 8 males and 8 females) at dose levels of 310, 625, 1250, 2500 and 5000 mg/kg bw. Animals were observed for 21 days for mortality and clinical signs. Deaths occurred in both sexes at dose levels of >=625 mg/kg bw; within 2 to 10 days. At 310 mg/kg bw, clinical signs were limited to slight hyperexcitability. At 625 mg/kg bw, urinary incontinence, muscular twitch, rapid respiration, hyperexcitability and exophthalmus were observed, and were more severe at >=1250 mg/kg bw. The acute dermal LD50 of fenitrothion was calculated to be 890 and 1200 mg/kg bw in males and females, respectively. Due to deficiencies in reporting, the study is not considered to be sufficiently reliable as a basis for classification.
Justification for classification or non-classification
Fenitrothion has a harmonised classification for acute oral toxicity in Category 4. This is consistent with the available data: the key study reports an acute oral LD50 of >300 -<2000 mg/kg bw. No change is proposed to the harmonised classification.
Fenitrothion does not have a harmonised classification for acute inhalation toxicity. This is consistent with the available data: the key study reports an acute inhalation LC50 of >2.21 mg/L (MAC). No change is proposed to the harmonised classification.
Fenitrothion does not have a harmonised classification for acute dermal toxicity. This is consistent with the available data: the key study reports an acute dermal LD50 of >2000 mg/kg bw. No change is proposed to the harmonised classification.
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