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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 225
- Modified dose descriptor starting point:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.9 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- LOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 37.5
- Dose descriptor:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.01 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.4 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- other: LOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
ACUTE:
Table:Available acute dose descriptors per endpoint for profenofos as a result of its hazard assessment
Endpoint |
Quantitative dose descriptor (appropriate unit) or qualitative assessment |
Associated relevant effect |
Remarks on study |
||
Local |
Systemic |
||||
Acute toxicity |
oral |
Not required |
Not required |
- |
- |
dermal |
LOAEC |
NOAEL 2000 mg/kg |
Local: Erythema and oedema Systemic: No observed effect |
Acute rat dermal study |
|
inhalation |
NOAEC |
NOAEC |
Local: signs of irritation post exposure Systemic: No observed effect |
Acute rat inhalation study |
Acute Dermal:
Local -
Dose descriptor selection: a NOAEC (local) value was not identified in the acute dermal toxicity study due to erythema and oedema observed at all levels. The lowest reliable dose descriptor available was LOAEC, with the value converted to mg/cm2 value based on the quantity of test material applied to the test area of skin (for the acute dermal rat study a dose area of approximately 5 in2, equivalent to 32.5 cm2 was used, with a mean bodyweight of 214g).
Acute NOAEL = 2000 mg/kg bw * 214g / 1000g / 32.5 cm2 =
Acute LOAEC = 13.2 mg/cm2 (termed LOAEC as local effects of erythema and oedema were observed)
Dose response: as no NOAEC was identified, additional assessment factor (AF) was applied according to the guidance in Chapter R.8.
AF: default AFs were applied according to the guidance in Chapter R.8 (note allometric scaling not relevant for local effects).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 * 5 * 1 *3 *1 = 37.5
DNEL deviation: N(L)OAEC / AF
- Acute DNEL dermal local = 13.2 cm2 / 37.5 = 0.4 mg/cm2
Systemic-
Dose descriptor selection: the lowest reliable dose descriptor was selected from the acute (rat) dermal study
Dose response: no systemic effects were observed, LD50 value identified. As no clinical signs of toxicity were observed the LD50 value was also deemed a NOAEL (systemic).
AF: default AFs were applied according to the guidance in Chapter R.8.
AF = Interspecies (including allometric scaling for rat to human) * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 *(4) * 5 * 1 *1 *1 = 50
DNEL derivation: NOAEL / AF
- Acute DNEL dermal systemic = 2000 mg/kg / 50 = 40 mg/kg
Acute inhalation:
Local -
Dose descriptor selection: a NOAEC (local) value was not identified in the acute inhalation toxicity study due to signs of respiratory irritation observed post dosing. In this limit study a single dose level where no deaths or systemic toxicological signs were observed was used as the dose descriptor. This value was corrected for duration of experimental exposure and human respiratory volumevs. worker respiration volume, according to the guidance in Chapter R.8 (Corrected NOAEC = NOAEC * experimental duration (x hrs) / human exposure duration (8 hrs) * human resting resp. volume (6.7 m3) / worker resp. volume (10 m3). Corrected NOAEC = 220 mg/m3 * 4/8 * 6.7/10 = 73.7 mg/m3)
Dose response: as no NOAEC was identified, additional assessment factor (AF) was applied according to the guidance in Chapter R.8.
AF: default AFs were applied, according to the guidance in Chapter R.8 (note allometric scaling not relevant for the inhalatory route of exposure).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 * 5 * 1 * 3 *1 = 37.5
DNEL deviation: Corrected NOAEC / AF
- Acute DNEL inhalation local & systemic = 73.7 mg/m3 / 37.5 = 2.0 mg/m3
Systemic –
Dose descriptor selection: the lowest reliable dose descriptor was NOAEL (systemic) value selected from the acute (rat) inhalation study. This value was corrected for duration of experimental exposure and human respiratory volume vs. worker respiration volume, according to the guidance in Chapter R.8 (Corrected NOAEC = NOAEC * experimental duration (x hrs) / human exposure duration (8 hrs) * human resting resp. volume (6.7 m3) / worker resp. volume (10 m3). Corrected NOAEC = 220 mg/m3 * 4/8 * 6.7/10 = 73.7 mg/m3).
Dose response: no systemic effects were observed, the LD50 value was also deemed a NOAEL (systemic).
AF: default AFs were applied, according to the guidance in Chapter R.8 (note allometric scaling not relevant for the inhalatory route of exposure).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 * 5 * 1 * 1 *1 = 12.5
DNEL deviation: Corrected NOAEC / AF
- Acute DNEL inhalation local & systemic = 73.7 mg/m3 / 12.5 = 5.9 mg/m3
Table Acute DNELs for workers
Endpoint Specific DNELs for Workers |
||||||
Endpoint |
Corrected dose-descriptor |
Overall AF |
Endpoint Specific DNEL |
|||
Local |
Systemic |
Local |
Systemic |
|||
Acute toxicity |
oral |
Not required |
Not required |
- |
- |
- |
Derm |
LOAEC 13.2 mg/cm2 |
NOAEL 2000 mg/kg |
Local 37.5 |
0.4 mg/cm2 |
40 mg/kg |
|
inhal |
LOAEC 73.7 mg/m3 |
NOAEC 73.7 mg/m3 |
Local 37.5 Systemic 12.5 |
2.0 mg/m3 |
5.9 mg/m3 |
REPEAT
Table Available repeat dose descriptors per endpoint for profenofos as a result of its hazard assessment
Endpoint |
Quantitative dose descriptor (appropriate unit) or qualitative assessment |
Associated relevant effect |
Remarks on study |
||
Local |
Systemic |
||||
Repeated dose toxicity sub-acute/ sub-chronic/ chronic |
oral |
Not required |
Not required |
- |
- |
dermal |
NOAEC 0.13 mg/cm2 |
NOAEL 2.5 mg/kg/day |
Local: erythema Systemic: Significant inhibition in brain cholinesterase activity |
21 day dermal, rabbit |
|
dermal |
Not tested |
- |
- |
- |
|
Inhalation (sub acute) |
LOAEC |
LOAEC |
Local: Signs of irritation, increased secretion of the mucous membranes of the nose Systemic: Significant inhibition in brain cholinesterase activity, reduction in food intake and bodyweight |
21-day inhalation, rat |
|
Inhalation (sub-chronic / chronic) |
Not tested |
- |
- |
- |
Repeat (sub-acute) dermal:
Local -
Dose descriptor selection: although ancanthosis was observed at all doses in the absence of any skin irritation (resulting in the author not establishing a NOAEL), the severity did not increase in a dose related manner. Furthermore, no such effects were observed in the supporting study. Therefore the observation of ancanthosis was not considered to be toxicologically significant. Discounting this observation, no dermal effects were observed up to the maximum dose tested, the NOAEC was derived from the maximum dose applied (10 mg/kg/day) in the sub-acute (21 day) rabbit dermal study. The NOAEL value was converted to mg/cm2 value based on the quantity of test material applied to the test area of skin (for the repeat dermal rabbit study animal weight ranged from 2420 to 3030g and the dose area of no less than 10% of the total body surface area (TBSA) was used. The 10% TBSA was calculated from Meek’s Formula (refer to 21 day dermal toxicity study report).
The 10% TBSA over the duration of the study ranged from 194.7 to 226.1 cm2. For the purposes of this CSR mean values for both weight and 10% TBSA have been calculated: 2725g and 210.4 cm2 respectively.
NOAEL = dose (mg/kg bw) * bw (g) / 1000g / skin area (cm2).
Sub-acute NOAEL = 2.5 mg/kg bw * 2725g / 1000g / 210.4 cm2
Sub-acute NOAEC = 0.03 mg/cm2
Dose response: no local effects, which were considered dose related were observed.
AF: default AFs were applied, according to the guidance in Chapter R.8 (note allometric scaling not relevant for local effects).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 * 5 * 1 * 1 *1 = 12.5
DNEL derivation: NOAEC / AF
- Repeat (sub-acute) DNEL dermal local = 0.13 mg/cm2 / 12.5 = 0.01 mg/cm2
Systemic -
Dose descriptor selection: the lowest reliable dose descriptor was selected from the sub-acute (21 day) dermal study.
Dose response: no systemic effects or clinical signs of toxicity were observed; therefore an NOAEL value was determined.
AF: default AFs were applied, according to the guidance in Chapter R.8.
AF = Interspecies (including allometric scaling for rabbit to human) * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 *(2.4) * 5 * 1 *1 *1 = 30
DNEL derivation: NOAEL / AF
- Repeat (sub-acute) DNEL dermal systemic = 2.5 mg/kg / 30 = 0.08 mg/kg
From the available toxicological data on brain acetylcholinesterase inhibition, the duration of the study does not markedly increase the level of inhibition of this enzyme (refer to Section 7.5, Table 7.5-1). Therefore, the sub acute DNELs for local and systemic effects are considered applicable for the both a sub-chronic and chronic exposure scenario without the need to apply further AF for duration extrapolation.
Repeat (sub-acute) inhalation:
Local / systemic -
Dose descriptor selection: a NOAEC was not identified in the sub-acute (21 day) rat inhalation study due to signs of irritation to mucous membranes of the eyes and nose (local effects) and inhibition of brain cholinesterase activity (systemic effects). The lowest reliable dose descriptor available was LOAEC. This value was corrected for duration of experimental exposure and human respiratory volumevs. worker respiration volume, according to the guidance in Chapter R.8. (Corrected LOAEC = LOAEC * experimental duration (x hrs) / human exposure duration (8 hrs) * human resting resp. volume (6.7 m3) / worker resp. volume (10 m3). Corrected NOAEC = 68 mg/m3 * 6/8 * 6.7/10 = 34.2 mg/m3).
Dose response: as no NOAEC was identified, additional AF was applied according to the guidance in Chapter R.8.
AF: Default AFs were applied, according to the guidance in Chapter R.8 (note allometric scaling not relevant for the inhalatory route of exposure).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database
AF = 2.5 * 5 * 1 * 3 *1 = 37.5
DNEL deviation: Corrected LOAEC / AF
- Repeat (sub-acute) DNEL inhalation local & systemic = 34.2 mg/m3 / 37.5 = 0.9 mg/m3
Extrapolation from a sub acute to sub-chronic / chronic exposure for local effects was not deemed relevant as the local effects would be expected to occur at the same dose irrespective of whether a sub-chronic or chronic scenario was utilised compared to a sub-acute dosing phase. The Repeat (sub-acute) DNEL inhalation for local effects would therefore provide protection in a sub-chronic / chronic scenario.
Repeat (sub-chronic) inhalation:
Local -
Refer toRepeat (sub-acute) DNEL inhalation local value.
Systemic –
Dose descriptor selection: a NOAEC was not identified in the sub-acute (21 day) rat inhalation study due to signs of irritation to mucous membranes of the eyes and nose (local effects) and inhibition of brain cholinesterase activity (systemic effects). The lowest reliable dose descriptor available was LOAEC. This value was corrected for duration of experimental exposure and human respiratory volumevs. worker respiration volume, according to the guidance in Chapter R.8. (refer above to Repeat (sub acute) inhalation). As the value was extrapolated from a sub-acute to a chronic scenario, additional AF was applied according to the guidance in Chapter R.8.
Dose response: as no NOAEC was identified, additional AF was applied according to the guidance in Chapter R.8.
AF: default AFs were applied, according to the guidance in Chapter R.8 (note allometric scaling not relevant for the inhalatory route of exposure).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database (note, no additional AF for exposure duration was used as human data confirm no adverse effects following use of Profenofos)
AF = 2.5 * 5 * 3 * 3 *1 = 225
DNEL deviation: Corrected LOAEC / AF
- Repeat (chronic) DNEL inhalation systemic = 34.2 mg/m3 / 112.5 = 0.3 mg/m3
Repeat (chronic) inhalation:
Local -
Refer toRepeat (sub-acute) DNEL inhalation local value.
Systemic –
Dose descriptor selection: a NOAEC was not identified in the sub-acute (21 day) rat inhalation study due to signs of irritation to mucous membranes of the eyes and nose (local effects) and inhibition of brain cholinesterase activity (systemic effects). The lowest reliable dose descriptor available was LOAEC. This value was corrected for duration of experimental exposure and human respiratory volumevs. worker respiration volume, according to the guidance in Chapter R.8. (refer to Section1.2.1). As the value was extrapolated from a sub-acute to a chronic scenario, additional AF was applied according to the guidance in Chapter R.8.
Dose response: as no NOAEC was identified, additional AF was applied according to the guidance in Chapter R.8.
AF: default AFs were applied, according to the guidance in Chapter R.8 (note allometric scaling not relevant for the inhalatory route of exposure).
AF = Interspecies * Intraspecies (worker) * Exposure duration * Dose-response * Quality of whole database (note, no additional AF for exposure duration was used as human data confirm no adverse effects following use of Profenofos)
AF = 2.5 * 5 * 6 * 3 *1 = 225
DNEL deviation: Corrected LOAEC / AF
- Repeat (chronic) DNEL inhalation systemic = 34.2 mg/m3 / 225 = 0.15 mg/m3
Table 7-4:Chronic DNELs for workers
Endpoint Specific DNELs for Workers |
||||||
Endpoint |
Corrected dose-descriptor |
Overall AF |
Endpoint Specific DNEL |
|||
Local |
Systemic |
Local |
Systemic |
|||
Repeated dose toxicity sub-acute/ sub-chronic/ chronic |
oral |
Not required |
Not required |
- |
- |
- |
dermal |
NOAEC mg/cm2 |
Starting dose not corrected (NOAEL 2.5 mg/kg/day) |
Local 12.5 |
0.01 mg/cm2 |
0.08 mg/kg |
|
Inhalation (sub-acute) |
LOAEC 34.2mg/cm2 |
LOAEC 34.2 mg/cm2 |
37.5 |
0.9 mg/m3 |
0.9 mg/m3 |
|
Inhalation (sub chronic) |
Local 37.5 |
0.9 mg/m3 |
0.3 mg/m3 |
|||
Inhalation (chronic) |
Local 37.5 |
0.9 mg/m3 |
0.15 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
The substance is formulated into plant protection products that are not used within the EU, therefore, exposure to the general public is not expected.
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