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EC number: 406-850-2 | CAS number: 133855-98-8 BAS 480 F
- 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
Epoxiconazole was non-irritant in the OECD 404 skin irritation study in White Vienna rabbits. This also holds true for eye irritation under OECD 405 test conditions.
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:
- 1987
- 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:
- May 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach (Main)
- Age at study initiation: not specified
- Weight at study initiation: female: 2.37kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40x51 cm; single
- Diet (e.g. ad libitum): Kliba 341, 4MM, Klingentalmuehle AG, 130g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the suspension
- Concentration (if solution):50% aqueous formulation - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:upper third of the back or flanks
- % coverage: semi-occlussive
- Type of wrap if used: porous dressing (four layers of absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure:4h
SCORING SYSTEM:
Erythema and edema:
0=none
1=very slight
2=well-defined
3=moderate to severe
4= severe to very severe - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 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:
- None of the animals showed erythema or edema.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions the substance does not show a skin irritating potential.
- Executive summary:
The substance was tested for its skin irritating potential. The test method was based on EPA (FIFRA) and OECD 404 guidelines. GLP requirements were fulfilled. Approx. 0.5g of a 50% aqueous suspension of the test substance was applied to the intact dorsal skin of 6 female white Vienna rabbits each under a semi-occlusive dressing for 4 hours. After the patches were removed the treated area was rinsed with Lutrol and Lutro/water (1:1).
No signs of irritation were observed after application.
Reference
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:
- 1988
- 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:
- May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- Nov 1982
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach (Main)
- Age at study initiation:
- Weight at study initiation: male: 3.10kg, female: 2.99kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40x51 cm
- Diet (e.g. ad libitum): Kliba 341, 4MM, Klingentalmuehle AG, 130g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 10-24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light - Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml bulk volume (about 31 mg of the comminuted test substance)
- Concentration (if solution): - Duration of treatment / exposure:
- Single application of the conjunctival sac of the right eyelid. The substance was not washed out.
- Observation period (in vivo):
- 72 h. Readings at 1 h, 24 h, 48 h, and 72 h
- Number of animals or in vitro replicates:
- 3 male and 3 female animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM:
Scale for scoring ocular lesions:
Chemosis and cornea opacity: 0=none, 1=well-defined, 2=severe, 4= very severe
Conjunctivae redness: 0=normal, 1=slight, 2=well-defined, 3=severe
Iris: 0=normal, 1=circum-corneal injection, 2=iritis
Discharge: 0=normal, 1=slightly increased, 2=clearly increased, 3=distinctly increased - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item does not show eye irritating properties and has not to be classified for eye irritation.
- Executive summary:
The substance was tested for its eye irritating potenital. The test method was based on EPA (FIFRA) and OECD 405 guidelines. GLP requirements were fulfilled. 0.1ml of the comminuted test substance was applied once to the eyes of 3 male and 3 female white Vienna rabbits. 1 hour after applciation slight redness and slightly increased discharge of the conjunctivae occurred. The symptoms were observed for a period of 48h. After 72h the reversibility could be demonstrated.
Reference
Table 1: Results acute eye irritation
Readings |
Animal |
Sex |
Cornea |
Iris |
Conjunctiva |
Symptoms |
|||
OP |
AR |
Red |
Sw |
DI |
|||||
1 h |
1 2 3 4 5 6 |
F M M F M F |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
1 1 1 1 0 0 |
0 0 0 0 0 0 |
0 1 1 1 1 1 |
|
24 h |
1 2 3 4 5 6 |
F M M F M F |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
2 1 2 2 0 0 |
0 0 0 0 0 0 |
0 1 0 0 0 0 |
|
48 h |
1 2 3 4 5 6 |
F M M F M F |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
1 1 1 1 0 0 |
0 0 0 0 0 0 |
0 1 0 0 0 0 |
|
72 h |
1 2 3 4 5 6 |
F M M F M F |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
|
Mean |
1 2 3 4 5 6 |
F M M F M F |
0.0 0.0 0.0 0.0 0.0 0.0 |
|
0.0 0.0 0.0 0.0 0.0 0.0 |
1.0 0.7 1.0 1.0 0.0 0.0 |
0.0 0.0 0.0 0.0 0.0 0.0 |
|
|
Mean |
|
|
0.0 |
|
0.0 |
0.6 |
0.0 |
|
|
OP=Opacity-degree of density; Sw=Chemosis; AR=Area of cornea involved; DI=Discharge; Red=Conjunctivae redness
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
The available data on irritation endpoints does 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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