Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
- EC Number:
- 406-850-2
- EC Name:
- (2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
- Cas Number:
- 133855-98-8
- Molecular formula:
- C17 H13 Cl F N3 O
- IUPAC Name:
- 1-{[(2R,3R)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiran-2-yl]methyl}-1H-1,2,4-triazole
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Weight at study initiation: males 273 +/- 8.6 g, females 193 +/- 6.2 g
- Age at study initiation: 8-9 weeks
- Housing: In groups of 5 in Type -D-III cages
- Diet ad libitum: Pelleted Kliba rat diet 343,
- Water ad libitum: Tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Remarks:
- supplied via a central air-conditioning system
- Mass median aerodynamic diameter (MMAD):
- 3.9 µm
- Geometric standard deviation (GSD):
- 2.3
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The animals were placed in tubes of the head-nose inhalation system INA 20 (BASF AG, chamber volume: 55l) with their snouts in an inhalation chamber with excess pressure. The test substance was dosed unchanged.
The dust/air mixture was generated by means of a microgenerator and the concentration was adjusted by varying the rotation of the metering disc. The supply air was conditioned via a central air-conditioning system and the air flow was set at 1500 l/h. Temperatures in the exposure system were 19 - 25°C.
By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10% lower (excess pressure). This ensured that the mixture of the test substance and air was not diluted with laboraoty air in the breathing zones of the animals.
AIR SAMPLING FOR ANALYSIS OF TEST MATERIAL CONCENTRATIONS, METHOD FOR PARTICEL SIZE ANALYSIS
Samples of the test atmosphere (1l) were taken adjacent to the animals’ nose once an hour with an air flow of 1.25 m/s. The concentration was determined gravimetrically.
Particle size analysis was done 30 minutes after the beginning of the test. A sample of 9 l was analyzed using an impactor. The MMAD was 3.9 µM and the GSD was 2.3. The respirable dust fraction was determined as 77%. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric determination of the inhalation atmosphere concentration
- Duration of exposure:
- 4 h
- Concentrations:
- The mean analytical concentration of 4 samples was 5.26 +/-0.07 mg/l. The nominal concentration was 63 mg/l.
- No. of animals per sex per dose:
- 5 males per dose, 5 females per dose
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations for clinical symptoms: Several times during exposure, afterwards at least once daily at workday.
- Frequency of observations for mortality: Daily
- Frequency of weighing: On first day (before exposure), day 7 and day 14.
- Necropsy of survivors performed: yes, all animals were sacrificed and subjected to gross pathology at study termination. - Statistics:
- The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp. 32 35) in accordance with tables of the BASF Computer Center.
The calculation of the particle size distribution was carried out in the Department of Toxicology of BASF Aktiengesellschaft on the basis of mathematical methods for evaluating particle measurements (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235 -259).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.3 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: No mortality occured.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: During exposure accelerated breathing and a slight reddish discharge from noses were seen. The slight reddish discharge persisted after exposure but no abnormalities were detected from day one onward.
- Body weight:
- The body weight gain of male and female rats in the test group was comparable to the historical control (for details see Table 1).
- Gross pathology:
- Upon necropsy no pathological findings were observed.
- Other findings:
- Signs of airway irritation during and shortly after exposure; no symptoms thereafter.
MMAD = 3.9µm
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose via inhalation of the test item in rats is higher than 5.3 mg/L.
- Executive summary:
The substance was tested for its acute inhalation toxicity. The test method was based on EPA (FIFRA) and OECD 403 guidelines. GLP requirements were fulfilled. 5 mal and 5 female Wistar rats were exposed to a concentration of 5.3 mg/L of the test substance for a period of 4 hours. During and up to one day after the exposure inhalation specific clinical symptoms were observed. No mortality occurred. Thus, the inhalation LC50 (4h) in rats is higher than 5.3 mg/L.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.