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EC number: 620-365-5 | CAS number: 9016-72-2
- 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
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- 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
The test substance is not skin or eye irritating as shown in reliable in vivo skin and eye irritation studies.
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:
- 2010/03 to 2010/06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24th April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008, B.4
- Version / remarks:
- 30 May 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Esd:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2 to 4 months old.
- Weight at study initiation: 2.8 to 3.2 kg.
- Housing: The animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: 110 Pelleted diet, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12
- ventilation : approximately 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: 9 to 26 March 2010 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- A gauze pad moistened with purified water.
- Controls:
- yes
- Amount / concentration applied:
- Single dose of 500 mg
- Duration of treatment / exposure:
- The anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals. The day before treatment, both flanks of each animal were clipped using electric clippers and just before treatment, the skin of each animal was examined in order to check the absence of any signs of skin irritation. The test item was first evaluated on a single animal.
Doses of 500 mg of the test item in its original form were placed on a gauze pad moistened with purified water, which was then applied to an area of approximately 6 cm2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. The untreated skin served as control. After removal of the dressing, any residual test item was wiped off by means of a dry or moistened cotton pad. - Observation period:
- 1, 24, 48, 72 hours, and observation period was extended up
to their complete reversibility (day 8).daily until day 8 - Number of animals:
- 3
- Details on study design:
- Each animal was weighed at the beginning (before treatment) and at the end of the observation period. At the end of the observation period, the animals were not sacrificed. They were used subsequently for the evaluation of the ocular irritation potential on the same test item.
The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Since there were persistent irritation reactions at 72 hours, the observation period was extended up to their complete reversibility (day 8). The degree of erythema/eschar formation and oedema formation was recorded as specified by DRAIZE and any serious lesions or toxic effects other than dermal irritation were also recorded and fully described.
Each animal was weighed at the beginning (before treatment) and at the end of the observation
period. At the end of the observation period, the animals were not sacrificed. They were used
subsequently for the evaluation of the ocular irritation potential on the same test item. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Dryness of the skin was noted in 1/3 animals from day 4 until day 7.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The potential of the test item Propineb (AE F074263) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.4, 30 May 2008) guidelines. A single dose of 500 mg of the test item in its original form was applied to the closely-clipped
skin of one flank. Under the experimental conditions of this study, the test item Propineb (AE F074263) was
slightly irritant when applied topically to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the Propineb does not trigger classification as irritating to the skin. - Executive summary:
The potential of the test item Propineb (AE F074263) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.4, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice
Regulations.The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test item was neither severely irritant nor corrosive on this first animal, it was then applied sequentially for 4 hours to two other animals.
A single dose of 500 mg of the test item in its original form was applied to the closely-clipped skin of one flank.The test item was held in contact with the skin by means of a semi occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions (day 8). The mean values of the scores for erythema and edema were calculated for each animal. The interpretation of results was carried out according to the classification criteria laid down in
Council Directive 67/548/EEC (and subsequent adaptations).
After a 3-minute exposure (one animal) No cutaneous reactions were observed. After a 1-hour exposure (one animal) A very slight or well-defined erythema was noted from day 1 until day 4. Dryness of the skin was observed from day 2 until day 7. After a 4-hour exposure (three animals) A very slight or well-defined erythema was noted in all animals from day 1 until day 3 (two animals) or day 4 (one animal). A very slight edema was noted in another animal on day 1. Dryness of the skin was noted in 1/3 animals from day 4 until day 7. Mean scores over 24, 48 and 72 hours for each animal were 1.7, 0.7 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema.
Under the experimental conditions of this study, the test item Propineb (AE F074263) was slightly irritant when applied topically to rabbits. However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the skin.
Reference
Table one
Individual skin irritation scores for eryther according to the Draize scheme on the first animal
Duration of exposure | 3 minutes | 1 hour | ||
| Erythema | Oedema | Erythema | Oedema |
1 hour | 0 | 0 | 2 | 0 |
24 hours | 0 | 0 | 1 S | 0 |
48 hours | 0 | 0 | 1S | 0 |
72 hours | 0 | 0 | 1S | 0 |
Mean score | 0 | 0 | 1 | 0 |
No positive response: mean scores < 2 = - Positive response : mean scores ³ 2 = + |
Table two
Individual and mean skin irritation scores after 4 hour exposure according the
Draize scheme
| Erythema and eschar | Oedema | ||||
Animal number | 1 (2.8) | 2 (3.0) | 3 (3.2) | 1 (2.8) | 2 (3.0) | 3 (3.2) |
1 hour | 2 | 1 | 2 | 0 | 0 | 1 |
24 hours | 2 | 1 | 2 | 0 | 0 | 0 |
48 hours | 2 | 1 | 1 | 0 | 0 | 0 |
72 hours | 1S | 0 | 0 | 0 | 0 | 0 |
120 hours | 0 | - | - | 0 | - | - |
Mean score | 1.7 | 0.7 | 1.0 | 0 | 0 | 0 |
No positive response: mean scores < 2 = - Positive response : mean scores ³ 2 = + |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010/03/19 to 2010/04/09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008, B.5
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2 to 4 months old.
- Weight at study initiation: 3.2 to 3.4 kg.
- Housing: The animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: 110 Pelleted diet, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: 26 March to April 10 2010. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. The eyes were not rinsed after administration of the test item
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 5 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Just before treatment, the eyes of each animal were examined in order to check the absence of any signs of ocular irritation, ocular defects or pre-existing corneal injury. The test item, propineb, was first administered to a single animal. Since the test item was not severely irritant on this first animal, it was then evaluated sequentially on two other animals. A single dose of 100 mg of the test item, propineb, in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test item. The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item. Since there were persistent ocular reactions at 72 hours, the observation period was extended up to their complete reversibility (day 5). Conjunctival reactions, iritis and corneal opacification were evaluated daily for each animal.
For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary. The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described. Each animal was weighed at the beginning (before treatment) and at the end of the observation period. - Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was administered to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.5, 30 May 2008) guidelines. A single dose of 100 mg of the test item in its original form was introduced into the left conjunctival sac. The right eye was not treated and served as control. Under the experimental conditions of the study, the test item was slightly irritating when administered by ocular route to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item propineb should not be classified as irritating to the eyes
- Executive summary:
The potential of the test item, Propineb, to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.5, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
The test item was first administered to a single male New Zealand White rabbit. Since the test item was not severely irritant on this first animal, it was then evaluated sequentially in two other animals. A single dose of 100 mg of the test item in its original form was introduced into the left conjunctival sac. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions (day 5). The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).
A slight or moderate chemosis was noted from day 1 in all animals, persisting until day 2 in one animal and until 4 in another one. A slight to severe redness of the conjunctiva was observed in all animals on days 1 and 2, persisting in one of them until day 4. A clear discharge was noted on day 1 in all animals, persisting in two of them on day 2. An iritis was noted in 1/3 animals on day 1.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 0.7 and 0.0 for chemosis, 2.0, 0.7 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. Under the experimental conditions of the study, the test item Propineb was slightly irritant when administered by ocular route to rabbits. However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the eyes.
Reference
Table one
Eye irritation scores according to the Draize scheme
| Cornea | Iris | Conjunctiva-redness | Conjunctiva-chemosis | ||||||||
Animal number (body weight in kg) | 972 (3.2) | 970 (3.2) | 971 (3.4) | 972 (3.2) | 970 (3.2) | 971 (3.4) | 972 (3.2) | 970 (3.2) | 971 (3.4) | 972 (3.2) | 970 (3.2) | 971 (3.4) |
Time of observation |
|
|
|
|
|
|
|
|
|
|
|
|
1 hour | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 2 | 3 | 2 | 2 | 2 |
24 hours | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 2 | 0 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 |
120 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Mean scores 24-72 hours | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.0 | 0.7 | 0.3 | 1.0 | 0.7 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key skin irritation study according to OECD 404 and GLP is available (M-370061-01-1). Doses of 500 mg of the test item in its original form were placed on a gauze pad moistened with purified water, which was then applied to an area of approximately 6 cm2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
After a 3-minute exposure (first animal): no cutaneous reactions were observed.
After a 1-hour exposure (first animal): a very slight or well-defined erythema (grade 1 or 2) was noted from day 1 until day 4. Mean score for erythema between 24 and 72 hours: 1. Dryness of the skin was observed from day 2 until day 7.
After a 4-hour exposure (three animals): a very slight or well-defined erythema (grade 1 or 2) was noted in all animals from day 1 until day 3 (two animals) or day 4 (one animal). A very slight edema (grade 1) was noted in another animal on day 1. Dryness of the skin was noted in 1/3 animals from day 4 until day 7. Mean scores over 24, 48 and 72 hours for each animal were 1.7, 0.7 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema, respectively.
A key eye irritation study according to OECD 404 and GLP is available (M-370060-01-1). A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test item.
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item. Since there were persistent ocular reactions at 72 hours, the observation period was extended up to their complete reversibility (day 5). A slight or moderate chemosis (grade 1 or 2) was noted from day 1 in all animals, persisting until day 2 in one animal and until 4 in another one.
A slight to severe redness of the conjunctiva (grades 1 to 3) was observed in all animals on days 1 and 2, persisting in one of them until day 4. A clear discharge was noted on day 1 in all animals, persisting in two of them on day 2. An iritis (grade 1) was noted in 1/3 animals on day 1. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 0.7 and 0.0 for chemosis, 2.0, 0.7 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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