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EC number: 261-351-5 | CAS number: 58594-72-2
- 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
- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- GPMT
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1990-09-19 to 1990-10-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The US Federal Register Vol. 50, No.188, subpart 798.4100
- Version / remarks:
- September 27, 1985
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA: Pesticide Assessment Guidelines, Subdibision F - Hazard Evaluation: Human and Domestic Animals - Series 81-6: Dermal Sensitization
- Version / remarks:
- Addendum 4 on Data Reporting (January 1988)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Agricultural Chemicals Law and Regulations Japan (II); Testing Guidelines for Toxicology Studies, pp. 27-29: Dermal Sensitization Toxicity Study
- Version / remarks:
- January 28, 1985
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable GMPT was performed before entry into force of the REACH Regulation
Test material
- Reference substance name:
- 1-[2-(allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
- EC Number:
- 252-615-0
- EC Name:
- 1-[2-(allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
- Cas Number:
- 35554-44-0
- Molecular formula:
- C14H14Cl2N2O
- IUPAC Name:
- (±)-1-(β-allyloxy-2,4-dichloro-phenylethyl) imidazole / (±)-allyl 1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: crystalline solid
- Appearance: Yellow to brown crystalline solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: G3A561
- Expiration date of the lot/batch: Not specified
- Purity: 98.1%
- Manufacturing Date: 1989-01-23
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in closed containers.
- Solubility and stability of the test substance in the solvent/vehicle: The stability of imazalil in 1% sesam oil (with or without FCA), 10% petrolatum, and 5% petrolatum was controlled and guaranteed. All mixes were prepared for immediate use.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Test facility permanent non-inbred laboratory colony
- Females (if applicable) nulliparous and non-pregnant: not applicable
- Age at study initiation: Not specified
- Weight at study initiation: 300-400g
- Housing: Housed in an air-conditioned room and placed individually in numbered metallic cages. The cages were placed in racks.
- Diet (e.g. ad libitum): "Hope-farms" standardized pellets administrated in slef-raising hoppers and fed ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One-week
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified
- IN-LIFE DATES: From: 1990-09-19 To:1990-10-13
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesam oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- day 0
- Adequacy of induction:
- other: produced no necrosis at the injection site
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10%
- Day(s)/duration:
- day 7; 48h occlusive patch
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5%
- Day(s)/duration:
- day 21; 24 hours occlusive patch
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 2 main groups (vehicle induced and imazalil induced) of 20 animals each.
- Details on study design:
- RANGE FINDING TESTS:
The formulations used were chosen based upon a screen test which indicated that the 1% solution in sesam oil alone produced no necrosis at the injection site. The 10% powder in petolatum produced a slight erythema at the application site whereas the 5% powder in petrolatum did not result in erythema when applied to the skin of guinea-pigs during 24h under occlusive patch.
MAIN STUDY
A. INTRADERMAL INDUCTION - Day 0
- No. of exposures: Once
- Site: depilated nuchal area
- Concentrations:
The following injections were given:
- 2 injections of 0.1 mL of Freund's complete adjuvant blended with an equal amount of water
- 2 injections of 0.1 mL of the test article formulation close to the first 2 injections
- 2 injections of 0.1 mL of the test article formulation emulsified with Freund's complete adjuvant
Test groups: 1% solution in sesam oil
Control group: 100% sesam oil
B. EPICUTANEOUS INDUCTION - Day 7
- The test article and vehicle formulations were held in contact with the skin under an occlusive patch during 48 hours.
- The vehicle-induced group received the vehicle formulations.
- Scoring was perfromed 24 hours later.
C. CHALLENGE EXPOSURE - Day 21
- Two weeks after the epicutaneous induction a formulation of 5% imazalil in pertrolatum was applied epicutaneously on the left shaved flank under occlusive patch during 24 hours.
- Challenge controls:
- not specified
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
- Positive control results:
- A positive sensitizer, DNCB was additionally evaluted in a separate study (Exp no. 2216). A 100% sensitization rate was obtained 48 and 72h.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% test item in petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% test item in petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 100% sensitization rate
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 100% sensitization rate
Any other information on results incl. tables
Observations
All guinea-pigs survived the study. Body weights, which were recorded prior to and at the end of the study, were comparable between groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As appears from these data and when compared to the results of the positive control study with DNCB (exp no. 2216) where a 100% sensitization rate was obtained 48 and 72h.
Based on the sensitization rate obtained after the challenge exposure, the study director classified the test item as weak sensitizer (sensitization rate between 0 and 8%). However accroding to the criteria laid out in the CLP regulation, Imazalil should not be classified as skin sensitizer.
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