Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 410-400-0 | CAS number: 88671-89-0 SYSTHANE TECHNICAL
- 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
Two in vivo studies are available addressing the effects of myclobutanil on rabbit skin. In both studies myclobutanil showed no skin irritation.
Two in vivo studies are available for effects on the eye. In the first study moderate eye irritation in the rabbit was observed. In the second study, vascularisation was evident at the end of study in one rabbit and a hazy yellow stained cornea in another rabbit.
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:
- 2005-06-24 to 2005-07-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 202
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC
- Age at study initiation: Young adult
- Weight at study initiation: not given in the report
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Purina Certified High Fiber Rabbit Diet
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 69-70%RH
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test item (0.77 g of the test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Individual dose sites were scored at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal.
- Number of animals:
- 3 (1 Male and 2 Females)
- Details on study design:
- TEST SITE
- Area of exposure: 6-cm^2 intact dose site on each animal
- Type of wrap if used: 3-inch Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently cleansed of any residual test substance
- Time after start of exposure: 4 hours after exposure
OBSERVATION TIME POINTS
approximately 30-60 minutes, 24, 48, and 72 hours after patch removal
SCORING SYSTEM:
Individual dose sites were scored according to the Draize scoring system (see Table 3 below) - Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no edema observed at any treated site during this study. One hour after patch removal, all
three treated sites exhibited very slight erythema. The overall incidence and severity of irritation
decreased thereafter. All animals were free of dermal irritation by 72 hours. - Other effects:
- All animals appeared active and healthy during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A primary skin irritation test was conducted with Myclobutanil according to OECD/ EC guidelines and GLP principles. Under the conditions of this study, Myclobutanil caused very slight erythema, which cleared by 72 hours.
- Executive summary:
A primary skin irritation test was conducted with New Zealand albino rabbits to determine the potential for Myclobutanil to produce irritation after a single topical application. Under the conditions of this study, the test substance caused very slight erythema, which cleared by 72 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al. There was no edema observed at any treated site during this study. One hour after patch removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation (maximum score 1) decreased thereafter. All animals were free of dermal irritation by 72 hours.
Reference
Individual skin irritation scores are presented in Table 1. A summary of primary skin irritation scores is presented in Table 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:
- weight of evidence
- Study period:
- 29-May-1984 to 19-June-1984
- 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 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- 0.1 g of the ground amber solid test substance was applied to the corneal surface of 6 rabbits. Another 3 rabbits were treated, the eyes of these rabbits were irrigated with water for approximately 60 seconds starting 20-20 seconds after dosing. The eyelids were held open momentarily after dosing and then released gently to allow the animal to blink freely. The treated eyes were scored according to Draize's Procedure at 24, 48 and 72 hours after instillation, and at day 7, 14 and 21.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Crude myclobutanil; 95.7% purity
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland. Denver. PA.
- Age at study initiation: Young adult
- Weight at study initiation: approximately 2.0 - 3.5 kg
- Housing: Rabbits were housed individually in stainless steel cages
- Diet: Purina Laboratory Rabbit Chow
- Water: Drinking quality water was available ad libitum either by an automatic watering system or by water bottles.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Photoperiod (hrs dark / hrs light): 12-hr light/dark - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1g of the ground amber solid test substance was applied to the corneal surface
- Observation period (in vivo):
- The treated eyes were scored for signs of eye irritation at 24, 48 and 72 hours and at 7, 14 and 21 days after dose application.
- Number of animals or in vitro replicates:
- 6 males (no washing after instillation);
3 males (eyes were rinsed with water 20-30 seconds after instillation) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: For 3 of these rabbits, the treated eyes were irrigated with water for approximately 60 seconds. The treated eyes of the rest of the rabbits were remained unwashed.
- Time after start of exposure: 20-30 seconds after dosing
SCORING SYSTEM: The severity of the ocular effects were scored according to the system of Draize (J. Pharmacol, Exp. Therap. 82, 377-390, 1944).
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 20
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 7.8
- Max. score:
- 80
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- after 21 days: 1 animal with 1-2mm long blood vessel extended onto cornea; another animal: a 3 mm distinct hazy yellow area stain on the cornea
- Irritant / corrosive response data:
- For rabbits with unwashed eyes, slight to moderate irritation was observed in the cornea (6/6), iris (3/6) and conjunctiva (6/6) at 24 hours post-dosing. An uneven, pitted area was observed at the centre of the cornea of one rabbit with corneal and conjunctival effects. Test substance was noted to be present in the eyes of 3/6 rabbits, and around the eyes of the remaining 3 rabbits.
Irritation of reducing severity was present at 48 and 72 hours in the cornea (4/6 and 3/6, respectively) and conjunctiva (6/6 at both timepoints). Test substance was noted to be present around the eyes of the same 3 rabbits as before at 48 hours and in 1 rabbit at 72 hours.
At 7 days, irritation of the conjunctiva was still present in 2 rabbits. No irritation was observed at 14 and 21 days. However, a few blood vessels had extended into the cornea of one rabbit from Day 7 (one of the 3 rabbits with test material observed in the treated eye at 24 hrs) and, after dosing, a 3mm distinct hazy yellow stained area was seen on the cornea of another rabbit (one of the 3 rabbits with test material observed around the treated eye at 24, 48 and 72 hrs).
For rabbits with washed eyes, irritation was observed in all 3 animals in the conjunctiva at 24 hours, and only in 1 animal at 72 hours, respectively. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The results of an in vivo eye irritancy test performed in rabbits indicated long-lasting effects on the eye for crude myclobutanil. Based on the duration of the ocular effects, the test substance was considered severely irritating to the eyes of rabbits (i.e., vascularization of the cornea was present at 21 days). Irrigating the exposed eyes with water for 60 seconds beginning 20 to 30 seconds after exposure prevented the corneal effects, decreased the conjunctival effects and shortened the recovery period.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 24-June-2005 to 09-July-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- 99.7% purity
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services Inc., Clemmons, NC
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Purina Certified High Fiber Rabbit Diet
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 54-69%RH
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other:
- Amount / concentration applied:
- 0.1 mL (0.04 grams of the ground test substance)
- Duration of treatment / exposure:
- Not applicable: treated eyes were not rinsed after exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM: Ocular irritation was evaluated in accordance with Draize et al. (see Table 3 below)
TOOL USED TO ASSESS SCORE: A high-intensity white light (Mag Lite) - Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis.
Corneal opacity was evident in two rabbits by 24 hours. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 72 hours. Individual and mean eye irritation scores are presented in Table 1 and 2 respectively. - Other effects:
- All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse clinical signs, or abnormal behavior.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A primary eye irritation test was conducted according to OECD/EC guidelines and GLP principles. Under the conditions of this study, Myclobutanil (99.7% purity) caused corneal opacity, iritis, and conjunctival irritation, which cleared by 72 hours.
- Executive summary:
A primary eye irritation test was conducted according to OECD/EC guidelines and GLP principles. One-tenth of a milliliter (0.04 grams) of the ground test substance (99.7% purity) was instilled into the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis. Corneal opacity was evident in two rabbits by 24 hours. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 72 hours.
Referenceopen allclose all
The results are included in Table 1 below.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A primary skin irritation test was conducted with New Zealand albino rabbits to determine the potential for Myclobutanil to produce irritation after a single topical application. Under the conditions of this study, the test substance caused very slight erythema, which cleared by 72 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al. There was no edema observed at any treated site during this study. One hour after patch removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation (maximum score 1) decreased thereafter. All animals were free of dermal irritation by 72 hours.
A second study is available, in which Myclobutanil (0.5 mL) was applied to the skin of 6 male rabbits under a patch covered with an impervious cuff. After 4 hours exposure, the patches and cuffs were removed and the application sites were wiped gently. Erythema and edema were scored at 1 hour after removal, at 24 and 72 hours and after one week.
At no time point adverse skin effects were noted, as a result is this test substance considered practically non-irritating to the skin of rabbits.
A primary eye irritation test was conducted according to OECD/EC guidelines and GLP principles. One-tenth of a milliliter (0.04 grams) of the ground test substance (99.7% purity) was instilled into the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis. Corneal opacity was evident in two rabbits by 24 hours. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 72 hours. Based on this study no classification for serious eye damage or serious eye irritation is warranted.
In a second study, 0.1 g of the ground amber solid test substance (crude myclobutanil, 85.7% purity) was applied to the corneal surface of 6 rabbits. Another 3 rabbits were treated, the eyes of these rabbits were irrigated with water for approximately 60 seconds starting 20-30 seconds after dosing. The eyelids were held open momentarily after dosing and then released gently to allow the animal to blink freely. The treated eyes were scored according to Draize's Procedure at 24, 48 and 72 hours after instillation, and at day 7, 14 and 21. The results of this in vivo eye irritancy test performed indicated long-lasting effects on the eye. Based on the duration of the ocular effects, the test substance was considered severely irritating to the eyes of rabbits (i.e., vascularization of the cornea was present at 21 days). Irrigating the exposed eyes with water for 60 seconds beginning 20 to 30 seconds after exposure prevented the corneal effects, decreased the conjunctival effects and shortened the recovery period.
The results of the study performed using crude myclobutanil indicate that classification as Eye Dam. Cat 1 is appropriate for this grade of material. However, the results of the study performed with material of higher (99.7%) purity representative of the registered substance do not trigger CLP classification for serious eye damage or serious eye irritation. The different results of the two studies indicate that the eye irritation is due to the presence of process impurities. Nonetheless, myclobutanil has a harmonised CLP classification for serious eye irritation in Category 2. While the available data indicate that this classification is not required, the classification cannot be removed without specific consultation and the submission of a separate CLH dossier.
Justification for classification or non-classification
Based on the available data it is concluded that Myclobutanil does not have to be classified for skin irritation or corrosion according to the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008).
A harmonised classification for Myclobutanil is available for serious eye irritation (Cat. 2, H319)). The available data for high purity myclobutanil indicate that classification for serious eye irritation (Cat. 2) or serious eye damage (Cat. 1) is not required; however removal of the harmonised classification is beyond the scope of the REACH registration dossier.
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.