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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Sep 1984 to 15 Oct 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute 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:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 18 - 24 g
- Fasting period before study: 18-20 hours prior and 4 hours after dosing
- Diet: Ad libitum (analysed for contaminants)
- Water: Ad libitum except for 2 hours prior and 3 - 4 hours after dosing
- Acclimation period: 3 - 8 days prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 25 Sep 1984 to 15 Oct 1984
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg - Doses:
- 125, 160, 250, 320, 400, 500, 640 and 800 mg/kg
- 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 observations: Animals were observed for 1 hour following treatment and at hourly intervals for the remaining of the first day and twice daily for the remaining 14 days.
- Frequency of weighing: Individual body weights on day 1, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic post-mortem examination. The macroscopic appearance of abnormal organs was recorded. - Statistics:
- The acute oral LD50 was determined using the probit method of L.C. Miller and M.L. Tainter (Proc. Soc.exper. Biol. Med.~ (1944) p. 26).
Results and discussion
- Preliminary study:
- A preliminary study was carried out to establish a dosing regime. See table 1 in ''Any other information on results''
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 200 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 218 mg/kg bw
- Based on:
- test mat.
- Mortality:
- See table 2 in ''Any other information on results incl. tables''.
- Clinical signs:
- other: The most common symptoms were weakness, dizziness, decreased movement, flaccidity, ataxia, laboured and decreased respiration. The first onset of symptoms occurred within 9- 10 minutes after dosing. The longest duration of symptoms lasted 72 hours in the
- Gross pathology:
- No particular findings were noted on any organ or tissue at necropsy, neither in animals that died nor in the mice which survived the 14 day observation period.
Any other information on results incl. tables
Table 1. Results of preliminary study
Dosage mg/kg |
Mortality ratio (no. of deaths) (no. dosed) |
Time of death after dosing (hours} Males Females |
||
Males |
Females |
|||
125 |
- |
0/2 |
- |
- |
250 |
- |
0/2 |
- |
- |
500 |
1/2 |
2/2 |
74 |
29,29 |
1000 |
2/2 |
2/2 |
62,86 |
23,62 |
2000 |
2/2 |
2/2 |
14,38 |
14,38 |
4000 |
2/2 |
2/2 |
49,98 |
26,51 |
Table 2. Mortality in male and female NMR1 mice after oral administration of the test substance
Dose (mg/kg) |
Males (dead/treated) |
Time to death (days) |
Females (dead/treated) |
Time death (days) |
125 |
1/5 |
1 |
0/5 |
- |
160 |
1/5 |
1 |
1/5 |
2 |
250 |
4/5 |
1,2 |
4/5 |
2, 3 |
320 |
4/5 |
2,3 |
4/5 |
2, 3 |
400 |
5/5 |
1, 2, 3 |
5/5 |
1, 3 |
500 |
5/5 |
2, 3 |
5/5 |
2, 3, 4, 5 |
640 |
5/5 |
2, 3 |
5/5 |
2, 3 |
800 |
5/5 |
1, 2, 3 |
5/5 |
1, 2, 3, 4 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral LD50 was calculated to be 200 mg/kg for male and 218 mg/kg for female NMRI mice. The test substance is therefore considered toxic to mice after a single dose.
- Executive summary:
In a study that was performed in accordance with OECD 401 and according to GLP, 5 male and 5 female NMRI mice were exposed to the test substance to determine the potential to produce toxicity from a single dose via the oral route (gavage). The mice were once exposed at doses of 125, 160, 250, 320, 400, 500, 640 and 800 mg/kg of the test substance dissolved in DMSO. Animals were observed for 1 hour following dosing and at hourly intervals for the remainder of day 1. For the following 14 days animals were observed for symptoms and mortality in the morning and once in the evening.
Results showed that the maximum non-lethal dose was less than 125 mg/kg in male mice and 125 mg/kg in female mice. The minimum lethal dose was 125 mg/kg in males and 160 mg/kg in females. Earliest onset of lethality occurred 14 hours after dosing in the 125 mg/kg male group and in the 800 mg/kg male and female groups. The most common symptoms were weakness, dizziness, decreased movement, flaccidity, ataxia, laboured and decreased respiration. The first onset of symptoms occurred within 9- 10 minutes after dosing. The longest duration of symptoms lasted 72 hours in the 250 mg/kg group. Recovery was complete in the survivors of all groups by 96 hours.
Based on these findings, the acute oral LD50 was calculated to be 200 mg/kg for male and 218 mg/kg for female NMR1 mice. The test substance is therefore considered toxic to mice after a single dose.
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.