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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jul 2005 to 16 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:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200, January 28
- Version / remarks:
- 1985
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult (9-10 weeks)
- Weight at study initiation: Males 282-330 g and females 194-217 g at experimental start.
- 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: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 26 Jul 2005 to 16 Aug 2005
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 2 inch x 3 inch, 4-ply gauze pad was placed on a dose area of approximately 2 inches x 3 inches
- % coverage: 10% of the body surface
- Type of wrap if used: The gauze pad and entire trunk of each animal were wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing: After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed of any residual test substance.
TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: Individual body weights of the animals were recorded prior to test substance application (initial) and again on Days 7 and 14 (termination).
- Frequency of observations: The first several hours after application and at least once daily thereafter for 14 days
- Necropsy of survivors performed: yes, gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.
- Clinical signs: Gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnormal behaviour.
- Gross pathology:
- There were no signs of gross abnormalities.
Any other information on results incl. tables
Table 1. Individual body weights/weight gains and doses
Animal No. |
Sex |
Body Weight (g) |
Dose1 |
||||
Day 0 Weight |
Day 7 Weight |
Gain* |
Day 14 Weight |
Gain* |
g |
||
4106 |
M |
330 |
356 |
26 |
407 |
77 |
0.94 |
4107 |
M |
282 |
316 |
34 |
390 |
108 |
0.81 |
4108 |
M |
290 |
329 |
39 |
389 |
99 |
0.83 |
4109 |
M |
316 |
347 |
31 |
403 |
87 |
0.90 |
4110 |
M |
307 |
340 |
33 |
388 |
81 |
0.88 |
4111 |
F |
194 |
212 |
18 |
236 |
42 |
0.55 |
4112 |
F |
200 |
219 |
19 |
241 |
41 |
0.57 |
4113 |
F |
212 |
224 |
12 |
241 |
29 |
0.61 |
4114 |
F |
206 |
221 |
15 |
253 |
47 |
0.59 |
4115 |
F |
217 |
230 |
13 |
254 |
47 |
0.62 |
* - Body weight gain from Day 0.
1 The test substance was applied as a 70% w/w mixture in distilled water.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The single dose acute dermal LD50 of the test substance is greater than 2000 mg/kg of body weight in male and female rats.
- Executive summary:
An acute dermal toxicity study was performed in accordance with OECD TG 402 and according to GLP prinicples. The test was conducted with 5 male and 5 female Sprague-Dawley rats to determine the potential for the test substance to produce toxicity from a single topical application. 2000 mg/kg bw of the test substance was applied to the skin for 24 hours by using an occlusive dressing. The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days. Body weights were recorded prior to application and again on days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.
Results showed that all animals survived, gained body weight and appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 2000 mg/kg bw in male and female rats.
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