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EC number: 619-020-1 | CAS number: 94361-06-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jul 2005 to 1 Aug 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200, January 28, 1985
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
- Cas Number:
- 94361-06-5
- Molecular formula:
- C15H18ClN3O
- IUPAC Name:
- 2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week
- Water: ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 26 Jul 2005 to 1 Aug 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Distilled
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.71 g of the test mixture - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hour
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was applied by placing it on a 1 inch x 1 inch, 4-ply gauze pad .
- % coverage: 6 cm^2 intact dose site
- Type of wrap if used: The pad and entire trunk of each animal were wrapped with semi-occlusive 3 inch Micropore tape to avoid dislocation of the pad.
REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.
OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after patch removal
SCORING SYSTEM:
- Method of calculation: The classification of irritancy was obtained by adding the average erythema and edema scores for the 1, 24, 48, and 72-hour scoring intervals and dividing by the number of evaluation intervals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after patch removal, very slight erythema was noted for all three treated dose sites. All animals were free from dermal irritation within 24 hours.
- Other effects:
- All animals appeared active and healthy during the study. Apart from the skin irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour
Any other information on results incl. tables
Table 1. Individual skin irritation scores, erythema/oedema
Animal |
Sex |
Hours After Patch Removal |
|||
1 |
24 |
48 |
72 |
||
#1 |
M |
1/0 |
0/0 |
0/0 |
0/0 |
#2 |
F |
1/0 |
0/0 |
0/0 |
0/0 |
#3 |
M |
1/0 |
0/0 |
0/0 |
0/0 |
Total |
3/0 |
0/0 |
0/0 |
0/0 |
|
Mean |
1.0/0.0 |
0.0/0.0 |
0.0/0.0 |
0.0/0.0 |
Table 2. Summary of primary skin irritation scores
|
Hours |
|||
1 |
24 |
48 |
72 |
|
Erythema |
1.0 |
0.0 |
0.0 |
0.0 |
Oedema |
0.0 |
0.0 |
0.0 |
0.0 |
TOTAL (PDI)2 |
1.0 |
0.0 |
0.0 |
0.0 |
Primary Dermal Irritation Index (PDII) : (PDI for 1, 24, 48 and 72 hours) /4=0.3
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance is slightly irritating to the skin, but not sufficient for classification under CLP.
- Executive summary:
In a primary skin irritation test that was performed in accordance with OECD TG 404 and GLP principles, 2 males and 1 female New Zealand White rabbit were used to determine the potential for the test substance to produce irritation after a single topical application. Five-tenths of a gram of the test substance was moistened with distilled water and then applied to the skin for 4 hours using a semi-occlusive dressing. Following exposure, dermal irritation was evaluated by the method of Draize et al. Observations were done at 1, 24, 48, and 72 hour after patch removal.
Results showed that one hour after patch removal, very slight erythema was noted for all three treated dose sites. All animals were free from dermal irritation within 24h. The Primary Dermal Irritation Index (PDII) calculated for this substance was 0.3. The mean average scores for oedema and erythema was 0 for all the animals for 24, 48, and 72h.
Under the conditions of this study, the test substance is slightly irritating to the skin, but not sufficient for classification under CLP.
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