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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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Aug 1985 to 19 Sep 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- no
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:
- Wistar
- Remarks:
- KFM-HAN
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks, same age for male and female rats
- Weight at study initiation: Males: 247- 285 g, females: 203- 227 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least one week under laboratory conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 2
- Humidity (%): 55± 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 21 Aug 1985 to 19 Sep 1985
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Remark on MMAD/GSD:
- From the particle size distribution observed it could be stated that a mean particle size of approximately 41% in the low dose and 68% in high dose was within a size range of 1 to 5 microns.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 100 L
- Method of holding animals in test chamber: During the experiment, rats were placed around the exposure chamber in separate radial polyvinylchloride tubes with their snouts and nostrils exposed to the aerosol only.
- Rate of air (airflow): The air flow was 1000 L per hour and air pressure was 3 atmospheres.
- System of generating particulates/aerosols: The aerosol was generated by a nozzle. The test substance was supplied to the nozzle by a Grafix Exactomat Injector into a high velocity air stream. The nozzle discharged into the air of the chamber.
- Method of particle size determination: Gravimetric determination was performed using an 8-stage Andersen Ambient Particle Sizing Sampler with selectron filters, pore size 0.2 cm (micrometers) and 76 mm in diameter
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetrical determinations on selectron filters, pore size 0,2 cm and 50 mm in diameter
- Duration of exposure:
- 4 h
- Concentrations:
- 2.61 and 5.65 mg/L air
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of weighing: At day 1 (day of exposure), 8 and 15 of the test.
- Frequency of obervations: Four times during the first day and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: At the high dose, histopathological examination was performed on the nasal cavity, lungs with mainstream bronchi, liver, kidneys, adrenal glands and all gross lesions. Only gross lesions were examined at the low dose. - Statistics:
- The LC50 was estimated without use of a statistical model.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.65 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other:
- Remarks:
- Slight sedation, dyspnoea and ruffled fur were observed in all animals 4 hours post dosing
- Body weight:
- Body weight development was not affected in males; however females showed a reduction in body weight gain from day 1 to 8. By study termination females had recovered and showed no treatment related effects on body weight. See table 1 in ''Any other information on results incl. tables''.
- Gross pathology:
- No treatment-related findings were observed.
Any other information on results incl. tables
Table 1. Body weight gain in male and female rat following inhalation of the test substance
Animal No. |
Body weight males |
|||||
|
Conc. Test Substance 2606 mg/m3 |
Conc. Test Substance 5645 mg/m3 |
||||
|
Day 1 |
Day 8 |
Day 15 |
Day 1 |
Day 8 |
Day 15 |
1/ 11 |
261 |
289 |
309 |
260 |
272 |
300 |
2/ 12 |
254 |
287 |
310 |
248 |
252 |
283 |
3/ 13 |
284 |
320 |
340 |
282 |
300 |
328 |
4/ 14 |
272 |
302 |
319 |
272 |
272 |
310 |
5/ 15 |
247 |
269 |
285 |
260 |
280 |
330 |
|
Body weight females |
|||||
|
Day 1 |
Day 8 |
Day 15 |
Day 1 |
Day 8 |
Day 15 |
6/ 16 |
217 |
217 |
227 |
227 |
233 |
248 |
7/ 17 |
225 |
222 |
231 |
217 |
220 |
234 |
8/ 18 |
217 |
220 |
230 |
227 |
223 |
241 |
9/ 19 |
223 |
220 |
221 |
203 |
207 |
232 |
10/ 20 |
219 |
224 |
231 |
213 |
216 |
235 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the acute inhalation LC50 of the test substance suspended in air for male and female rats was determined to be higher than 5.65mg/ L air. No classification is required.
- Executive summary:
In this acute inhalation toxicity study performed in accordance with OECD TG 403 and in accordance with GLP principles, 5 male and 5 female Wistar rats per group were exposed to the test substance to determine the potential to produce toxicity from a single exposure. The rats were exposed to concentrations of 2.61 and 5.65 mg/L air of the test substance via the inhalation (nose-only exposure) route for 4 hours. The airflow was 1000 mL/ hour and air pressure was 3 atmospheres. The nozzle discharged into the air of the exposure chamber. The parameters of inhalation exposure including; oxygen content, relative humidity, temperature, particle size and airflow velocity were all monitored. The actual concentration of the test substance in the chamber was determined gravimetrically. The measurements were conducted at regular intervals throughout the exposure period. The study was terminated 15 days post dosing. The animals were observed for clinical signs of toxicity four times a day during the first day and daily thereafter. Individual bodyweights were recorded at day 1 (pre-test), day 8 and day 15 of the test. Necropsy was performed on all animals. At the high dose, histopathological examination was performed on the nasal cavity, lungs with mainstream bronchi, liver, kidneys, adrenal glands and all gross lesions. Only gross lesions were examined at the low dose.
Results showed that no animals died during the study. Slight sedation, dyspnoea and ruffled fur were observed in all animals 4 hours post dosing. All rats had recovered completely by 24 hours after initiation of exposure. Body weight development was not affected in males; however females showed a reduction in body weight gain from day 1 to 8. By study termination females had recovered and showed no treatment related effects on body weight.
Based on the results of this study, the acute inhalation LC50 of the test substance suspended in air for male and female rats was determined to be higher than 5.65 mg/ L air.
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