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EC number: 266-096-3 | CAS number: 66063-05-6
- 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
Guideline-compliant studies of skin and eye irritation in the rabbit are supported by non-guideline studies. These in vivo studies were performed prior to the validation and adoption of alternative methods.
Test Species/Type | Results | Assessment | Reference |
Not stated - | Pencycuron was not a skin irritant. | Supporting study | Thyssen and Lorke (1980) |
OECD 404 - | Pencycuron was not a skin irritant. | Key study | Maertins (1989) |
Indian guideline - Does not conform to OECD 404 | Pencycuron was not a skin irritant. | - no assessment at 48 hours, although a zero response at this timepoint could be assumed. Result consistent with other studies. | Unknown. (2005) |
Not stated (pre-dates OECD TG) - | Pencycuron was not an eye irritant. | Supporting study | Thyssen and Lorke (1980) |
OECD 405 - | Pencycuron was not an eye irritant. | Key study | Maertins (1989) |
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:
- supporting study
- Study period:
- 1980-03-30 to 1980-05-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was not performed in accordance with OECD 404, because the study report was very concise and essential information was lacking, such as: the test concentration was not indicated, the surface area exposed to the test substance was not indicated, it was unclear whether or not exposure was semi-occlusive, observation period. Therefore, the study could not be properly evaluated.
The study conformed to the recommended guidelines of the US Department of Agriculture (Federal Register, Vol.~' No. 187, p. 27019, 1973). The exposure period was 24 hours. - GLP compliance:
- no
- Remarks:
- older study, predates mandatory GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Not specified.
- Duration of treatment / exposure:
- 24
- Observation period:
- 72
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Unspecified.
- % coverage: Unspecified.
- Type of wrap if used: Unspecified.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unspecified.
- Time after start of exposure: Unspecified.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24, 72
SCORING SYSTEM:
- Method of calculation: Fed. Reg. 34, 64, p. 6100) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The study is of limited reliability due to deficiencies in design and reporting, but can be used as supporting information. The study is consistent with the key (guideline-compliant) study in demonstrating that pencycuron is not a skin irritant.
- Executive summary:
The skin irritation potential of pencycuron was investigated in a non-guideline study in the rabbit. The study is of limited reliability due to deficiencies in design and reporting, but can be used as supporting information. The study is consistent with the key (guideline-compliant) study in demonstrating that pencycuron is not a skin irritant.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-03-14 to 1990-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See Principles of method if other than guideline.
- Principles of method if other than guideline:
- The test methods were conducted in accordance with "OECD Guideline for Testing of Chemicals No. 404.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species and Species Justification
The study was performed using rabbits, an animal species recommended in the test guidelines. Healthy, adult albino rabbits (strain: HC:NZW) were used (bred by INTERFAUNA UK LTD.). The state of health of the breed was routinely tested for the most significant specific infective pathogens. If females were used, they were nulliparous and nonpregnant.
Experimental Animal Care
The rabbits were housed in individual cages under standardized conventional conditions (Type III wire cages, tall). Feces pans containing low-dust wood shavings (Type S 8/15; SSNIFF, in Soest, FRB) were located below the cages. These wood shavings were routinely analyzed for contaminants by the Central Office for Experimental Animal Concerns.
Identification of the Animals; The rabbits were identified by individual ear markings (tattooing) and cage I.D. cards.
Acclimatization; 1 day prior to application, the rabbits were examined to determine whether those scheduled for treatment were biologically normal. At least 14 days prior to treatment, the rabbits were clinically examined for diseases and acclimatized in the quarantine station. Shortly after arrival of the animals, feces samples were collected and examined for oocysts of coccidia.
Animal Quarters; All animals of this study were placed in one animal room. For reasons of capacity, rabbits treated with other test substances were also housed in the same animal room. Mix-ups with other animals were avoided by adequate spacing and separation, unambiguous cage and animal identification, and an appropriate scheduling of work.
Climatic Conditions in the Animal Room;
Conditions were adjusted as follows:
Room Temperature: 20° ± 3°C
Relative Humidity: approx. 50%
Light/Dark Cycle: 12 hours, artificial illumination from 6:00 a.m. to 6:00 p.m. MEZ [Middle European Time]
Illumination: approx. 27 watts/m^2 floor area
Air Exchange Rate: approx. 10 times per hour
The humidity and temperature in the animal quarters were recorded continuously using a calibrated thermohygrograph. There were occasional deviations from these conditions, e.g. as a result of the cleaning of the animal room. They had no detectable effect on the outcome of the study.
Cleaning. Disinfection, and Pest Control; All surface areas in the animal quarters were cleaned at least once per month and disinfected with Zephirol (1% in water); the floor in the animal quarters was cleaned and disinfected once per week. In so doing, contamination of the feed and contact with the experimental animals were avoided. No pest control was performed in the animal quarters. The water dispensers were cleaned once per week.
Diet;
Feed: standard diet (approx. 100 g to 120 g per animal per day; animals fed once per day in the morning).
Water: Tap water was available to the rabbits ad libitum between 7:00 a.m. and 7:00 p.m.
At the request of the Central Office for Experimental Animal Concerns, the nutrient composition and the contaminant content of the standard diet were checked routinely by taking random samples and analyzing them. These records are archived at the Central Office for Experimental Animal Concerns. The tap water was of drinking water quality (Drinking Water Ordinance dated May 22, 1986, Bundesqesetzblatt [Federal Law Bazettel, Part I, page 760). Results of the analyses of feed and water are archived at BAYER A6. These data provided no evidence of an effect on the study objective. Either approximately 750-ml polycarbonate bottles or automatic water dispensers were used to provide water.
Body Weights
The rabbits were weighed immediately prior to application of the test substance.
State of Health
Only healthy animals that were free of signs were used for the study. No vaccination or treatment of the animals with antibiotics was performed either prior to receipt of the animals or during the acclimatization period or the experimental period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 6 cm2 of 500mg.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: contralateral skin areas (approx. 6 x 6 cm) on the flanks
- % coverage: -
- Type of wrap if used: elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48, and 72 hours, 7 days
SCORING SYSTEM:
- Method of calculation:
The test substance was classified by calculating a primary skin irritation index (see Appendix Ib) by averaging the DRAIZE scores for erythema/eschar formation and edema observed at 24, 48, and 72 hours. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Not relevant: no irritation observed
- Other effects:
- - Other adverse local effects: none.
- Other adverse systemic effects: none. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Pencycuron was found to be non-irritant under the conditions of this study and does not require classification under CLP for skin corrosion or skin irritation.
- Executive summary:
Pencycuron (NTN 19701 Technical) was tested for skin corrosion and irritation potential in the rabbit in a study performed to OECD 404. 0.5 g of the test material was applied to the shorn dorsal skin of three rabbits under semi-occlusive conditions for 4 hours. Residual test material was removed by washing with water. Dermal reactions were scored at 1, 24, 48 and 72 hours; and at 7 days following patch removal, using the Draize scale. No signs of irritation were seen in any rabbit at any time point. Pencycuron was found to be non-irritant under the conditions of this study and does not require classification under CLP for skin corrosion or skin irritation.
Referenceopen allclose all
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:
- supporting study
- Study period:
- 1980-03-30 to 1980-05-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was not performed in accordance with OECD 405, because the study report was very concise and essential information (e.g. test concentration) was not provided. The eyes were exposed for 5 minutes and 24 hours.
The study conformed to the recommended guidelines of the Department of Health, Education, and Welfare (Fed. Reg. Vol. 22,, No. 83 (1972), p. 8535). The following results were obtained with a 5-minute and a 24-hour period of exposure to the active ingredient in the conjunctival sac of rabbits' eyes (pages 4 - 5). - GLP compliance:
- no
- Remarks:
- older study predates mandatory GLP
- Species:
- rabbit
- Strain:
- Chinchilla
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Not specified.
- Duration of treatment / exposure:
- 5 and 24
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 5 m = 5
24 h = 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified.
- Time after start of exposure: Not specified.
SCORING SYSTEM: Fed. Reg. 22., 83 (1972), p. 8535
TOOL USED TO ASSESS SCORE: Not specified. - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- < 0.15
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 5 m exposure
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- < 0.15
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 24 h exposure
- Irritant / corrosive response data:
- Also includes 5 m, 1 h and 7 d timepoints.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The study is of limited reliability due to deficiencies in design and reporting, but can be used as supporting information. The study is consistent with the key (guideline-compliant) study in demonstrating that pencycuron is not an eye irritant.
- Executive summary:
The eye irritation potential of pencycuron was investigated in a non-guideline study in the rabbit. The study is of limited reliability due to deficiencies in design and reporting, but can be used as supporting information. The study is consistent with the key (guideline-compliant) study in demonstrating that pencycuron is not an eye irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-03-14 to 1990-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See Principles of method if other than guideline.
- Principles of method if other than guideline:
- The study was conducted in accordance with "OECD Guideline for Testing of Chemicals No. 405.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and Species Justification
The study was performed using rabbits, an animal species recommended in the test guidelines. Healthy, adult albino rabbits (strain: HC:NZW) were used (bred by INTERFAUNA UK LTD.). The state of health of the breed was routinely tested for the most significant specific infective pathogens. If females were used, they were nulliparous and nonpregnant.
Experimental Animal Care
The rabbits were housed in individual cages under standardized conventional conditions (Type III wire cages, tall). Feces pans containing low-dust wood shavings (Type S 8/15; SSNIFF, in Soest, FRB) were located below the cages. These wood shavings were routinely analyzed for contaminants by the Central Office for Experimental Animal Concerns.
Identification of the Animals; The rabbits were identified by individual ear markings (tattooing) and cage I.D. cards.
Acclimatization; 1 day prior to application, the rabbits were examined to determine whether those scheduled for treatment were biologically normal. At least 14 days prior to treatment, the rabbits were clinically examined for diseases and acclimatized in the quarantine station. Shortly after arrival of the animals, feces samples were collected and examined for oocysts of coccidia.
Animal Quarters; All animals of this study were placed in one animal room. For reasons of capacity, rabbits treated with other test substances were also housed in the same animal room. Mix-ups with other animals were avoided by adequate spacing and separation, unambiguous cage and animal identification, and an appropriate scheduling of work.
Climatic Conditions in the Animal Room;
Conditions were adjusted as follows:
Room Temperature: 20° ± 3°C
Relative Humidity: approx. 50%
Light/Dark Cycle: 12 hours, artificial illumination from 6:00 a.m. to 6:00 p.m. MEZ [Middle European Time]
Illumination: approx. 27 watts/m^2 floor area
Air Exchange Rate: approx. 10 times per hour
The humidity and temperature in the animal quarters were recorded continuously using a calibrated thermohygrograph. There were occasional deviations from these conditions, e.g. as a result of the cleaning of the animal room. They had no detectable effect on the outcome of the study.
Cleaning. Disinfection, and Pest Control; All surface areas in the animal quarters were cleaned at least once per month and disinfected with Zephirol (1% in water); the floor in the animal quarters was cleaned and disinfected once per week. In so doing, contamination of the feed and contact with the experimental animals were avoided. No pest control was performed in the animal quarters. The water dispensers were cleaned once per week.
Diet;
Feed: standard diet (approx. 100 g to 120 g per animal per day; animals fed once per day in the morning).
Water: Tap water was available to the rabbits ad libitum between 7:00 a.m. and 7:00 p.m.
At the request of the Central Office for Experimental Animal Concerns, the nutrient composition and the contaminant content of the standard diet were checked routinely by taking random samples and analyzing them. These records are archived at the Central Office for Experimental Animal Concerns. The tap water was of drinking water quality (Drinking Water Ordinance dated May 22, 1986, Bundesqesetzblatt [Federal Law Bazettel, Part I, page 760). Results of the analyses of feed and water are archived at BAYER A6. These data provided no evidence of an effect on the study objective. Either approximately 750-ml polycarbonate bottles or automatic water dispensers were used to provide water.
Body Weights
The rabbits were weighed immediately prior to application of the test substance.
State of Health
Only healthy animals that were free of signs were used for the study. No vaccination or treatment of the animals with antibiotics was performed either prior to receipt of the animals or during the acclimatization period or the experimental period. - Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µl of test substance (bulk volume) were applied in the conjunctival sac of one eyelid of each of 3 adult rabbits. This is equivalent to an applied weight of about 50 mg of the test substance.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Duration of post- treatment incubation (in vitro):
- Following application, the lids were gently held together for approximately 1 second.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline solution
- Time after start of exposure: 24 hours
SCORING SYSTEM:
In evaluating the results, only those findings which persisted for 24 hours or longer are used. The results were classified on the basis of the DRAIZE scores by calculating a primary eye irritation index for the cornea (degree of opacity) and iris as well as for the redness and swelling (chemosis) of the conjunctivae observed at approx. 24, 48 and 72 hours after application and averaging these scores. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- other: n/a
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Pencycuron was found to be non-irritant under the conditions of this study and does not require classification under CLP for serious eye damage or serious eye irritation.
- Executive summary:
Pencycuron (NTN 19701 Technical) was tested for eye irritation potential in the rabbit in a study performed to OECD 405. 0.1 g of the test material was instilled into one eye of three rabbits. Ocular reactions were scored at 1, 24, 48 and 72 hours; and at 7 days following patch removal, using the Draize scale. No signs of irritation were seen in any rabbit at any time point. Pencycuron was found to be non-irritant under the conditions of this study and does not require classification under CLP for serious eye damage or serious eye irritation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Studies in the rabbit show that pencycuron is not a skin irritant.
Studies in the rabbit show that pencycuron is not an eye irritant.
Pencycuron does not have a harmonised classification for skin or eye irritation. The results of the available studies demonstrate that pencycuron does not require CLP classification for skin corrosion or skin irritation; for serious eye damage or serious eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.