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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 October 2005 to 10 November 2005
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- Single application
- Observation period:
- 72 hrs
- Number of animals:
- 3 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Conclusions:
- Under the conditions of this study, the test material is classified as moderately irritating to the skin.
- Executive summary:
In a primary dermal irritation study,3 young adult New Zealand rabbits, 2 males and 1 females, were exposed via the dermal route to 0.5 mL of Profenofos Technical/animal. The test material was administered semi occluded as supplied for 4 hours to a clipped area of intact skin measuring ~1 inch2. Animals were then observed for 7 days. Irritation was scored using the Draize scheme.
Under the conditions of this study, the test material is classified as moderately irritating to the skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 7 September to 10 September 2004
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- Single application
- Observation period:
- 72 hrs
- Number of animals:
- 3 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Conclusions:
- Under the conditions of this study, the test material is described as slightly irritating to the skin.
- Executive summary:
In a primary dermal irritation study,3 young adult New Zealand rabbits, 1 males and 2 females, were exposed via the dermal route to 0.5 mL of Profenofos Technical/animal. The test material was administered semi occluded as supplied for 4 hours to a clipped area of intact skin measuring ~1 inch2. Animals were then observed for 3 days. Irritation was scored using the Draize scheme.
Under the conditions of this study, the test material is described as slightly irritating to the skin.
Referenceopen allclose all
Individual skin irritation scores are presented below, All animals appeared active and healthy. Apart from the skin irritation noted below, there were no other signs of gross toxicity, adverse pharmacological effects or abnormal behaviour.
One hour after patch removal, well defined erythema and slight oedema were noted for all three treated sites. The overall incidence and severity of irritation decreased with time. Apart from desquamation noted at all dose sites on Day 7, all animals were free from dermal irritation by study terminatin (Day 7).
The Primary Dermal Irritation Index for Profenofos Technical is 3.1.
Table 7.3.1-1: Individual and mean skin irritation scores according to the Draize scheme
|
Erythema/Oedema |
|||
Animal no |
15535/M |
15536/F |
15537/M |
Total |
|
4 HOUR EXPOSURE |
|||
1 hr |
2/2 |
2/2 |
2/2 |
6/6 |
24 hr |
2/2 |
2/2 |
2/1 |
6/5 |
48 hr |
1/1 |
2/1 |
2/1 |
5/3 |
72 hr |
1/0 |
1/0 |
2/1 |
4/1 |
7 days |
0/0* |
0/0* |
0/0* |
0/0* |
Mean |
2.0/2.0 |
2.0/1.7 |
1.7/1.0 |
1.3/0.7 |
* Desquamation present at dose site
Individual skin irritation scores are presented below, All animals appeared active and healthy. Apart from the skin irritation noted below, there were no other signs of gross toxicity, adverse pharmacological effects or abnormal behaviour.
One hour after patch removal, very slight to well-defined erythema and very slight oedema were noted for all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 72 hours.
The Primary Dermal Irritation Index for Profenofos Technical is 1.2.
Table 7.3.1 -2: Individual and mean skin irritation scores according to the Draize scheme
|
Erythema/Oedema |
||||
Animal no |
12553/F |
12554/M |
12555/F |
Total |
Mean |
|
4 HOUR EXPOSURE |
||||
1 hr |
1/1 |
1/1 |
2/1 |
4/3 |
1.3/1 |
24 hr |
1/0 |
1/0 |
1/1 |
3/1 |
1.0/0.3 |
48 hr |
1/0 |
0/0 |
1/1 |
2/1 |
0.7/0.3 |
72 hr |
0/0 |
0/0 |
0/0 |
0.0 |
0.0/0.0 |
Mean |
0.33 |
0.17 |
0.67 |
- |
0.39 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 November 2005 to 12 November 2005
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12 Nouan No. 8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72hr post dosing
- Number of animals or in vitro replicates:
- 1 male and 2 female rabbits
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Conclusions:
- Based on the results of this study, Profenofos Technical is classified as mildly irritating to the eye.
- Executive summary:
In a primary eye irritation study, 0.1 mL Profenofos Technical (undiluted) was instilled into the conjunctival sac of the right eye of three young adult New Zealand White rabbits. The left eye acted as a control. Animals were then observed for 3 days. Irritation was scored using the Draize scheme for unwashed eyes, with the system of Kay and Calandra used to classify the test material.
All animals appeared active and healthy during the study apart from the eye irritation noted, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
No corneal opacity or iritis was noted for any treated eye during the study. One hour after test material instillation conjunctivitis was noted for all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hour
Based on the results of this study, Profenofos Technical is classified as mildly irritating to the eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 9 September 2004 to 12 September 2004
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF59 NohSan No. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72hr post dosing
- Number of animals or in vitro replicates:
- 3 male rabbits
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- ca. 10.7
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: Classified as minimally irritating
- Conclusions:
- Based on the results of this study, Profenofos Technical (CGA15324) is described as minimally irritating to the eye. Positive effects cleared by 48 hours.
- Executive summary:
In a primary eye irritation study, 0.1 mL Profenofos Technical (undiluted) was instilled into the conjunctival sac of the right eye of three young adult New Zealand White rabbits. The left eye acted as a control. Animals were then observed for 3 days. Irritation was scored using the Draize scheme for unwashed eyes.
Within one hour after test material instillation, conjuctivitis was observed in all three treated eyes. One animal developed corneal opacity at 24 hours. All animals were free of ocular irritation within 48 hours.
Based on the results of this study, Profenofos Technical (CGA15324) is described as minimally irritating to the eye. Positive effects cleared by 48 hours.
Referenceopen allclose all
Findings are summarised below
Table 7.3.2-1: Eye irritation scores according to the Draize scheme
Time/ Rabbit |
Rabbit 1 |
Rabbit 2 |
Rabbit 3 |
|||||||||
|
Hours |
Hours |
Hours |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
||||||||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
||||||||||||
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
||||||||||||
A. Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B. Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
C. Discharge |
3 |
1 |
0 |
0 |
3 |
1 |
0 |
0 |
3 |
1 |
0 |
0 |
(A+B+C)x2 |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
Total |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
Additional criteria in Directive 93/21/EEC Point 3.2.6.2 fulfilled: Yes
All animals appeared active and healthy during the study apart from the eye irritation noted, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
No corneal opacity or iritis was noted for any treated eye during the study. One hour after test material instillation conjunctivitis was noted for all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hours.
The maximum mean total score of Profenofos Technical was 12.0
Findings are summarised below
Table 7.3.2 -2: Eye irritation scores according to the Draize scheme
Time/ Rabbit |
Rabbit 1 |
Rabbit 2 |
Rabbit 3 |
|||||||||
|
Hours |
Hours |
Hours |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
||||||||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
1 |
4 |
4 |
4 |
4 |
4 |
4 |
(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
||||||||||||
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
||||||||||||
A. Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B. Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
C. Discharge |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
(A+B+C)x2 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
12 |
6 |
0 |
0 |
Total |
10 |
4 |
0 |
0 |
10 |
9 |
0 |
0 |
12 |
6 |
0 |
0 |
Additional criteria in Directive 93/21/EEC Point 3.2.6.2 fulfilled: Yes
One animal exhibited soft faeces. The remaining animals appeared active and healthy during the entire study.
Within one hour after test material instillation, conjunctivitis was observed in all three treated eyes. One animal developed corneal opacity at 24 hours. All animals were free of ocular irritation within 48 hours.
The maximum mean total score of Profenofos Technical was 10.7
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The key study on Profenofos (purity 89%) reports that this test material is moderately irritating (mean irritation score of 12). The supporting study, in which a slightly higher purity (92.1%) of Profenofos was tested returned a result of minimally irritating (mean irritation score of 10.4). In both cases the irritation observed was fully reversible, either within 72 or 48 hours, respectively.
Eye irritation
The key study on Profenofos (purity 92.1%) reports that the test material was mildly irritating (mean irritation score of 10.4). The supporting study, in which a slightly lower purity (89%) of Profenofos was tested returned a result of mildly irritating (mean irritation score of 12). In both cases the irritation observed was fully reversible, either within 48 or 72 hours, respectively.
Respiratory irritation
Currently there are no guideline approved studies which have the objective to address respiratory irritation adequately. However, clinical toxicity data from the acute inhalation studies (Rattray, 2004 and Horath, 1982) were indicative of irritation of the respiratory tract (increased breathing rate and abnormal respiratory noise in some animals) post exposure.
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Although in both eye and skin irritation studies results indicates Profenofos is slightly/moderately irritating to eyes and skin, according to Regulation (EC) No 1272/2008 Prodenofos is not classified as an eye or skin irritant.
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