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EC number: 695-595-2 | CAS number: 83395-38-4
- 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:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted: 17th December 2001
- Deviations:
- not applicable
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001
- Version / remarks:
- No 24, 2001
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment No 19, 2000
- Version / remarks:
- No 19, 2000
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- prop-2-yn-1-yl 1H-imidazole-1-carboxylate
- EC Number:
- 695-595-2
- Cas Number:
- 83395-38-4
- Molecular formula:
- C7H6N2O2
- IUPAC Name:
- prop-2-yn-1-yl 1H-imidazole-1-carboxylate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: 2-propyn-1-yl 1H-imidazole-1-carboxylate
Batch no.: 0802-2#
CAS no.: 83395-38-4
Storage: Room temperature (20±5°C)
Expiry date: November 4, 2021
Appearance: white solid
Purity: 99.1 %
Homogeneity: homogeneous
Production date: 13. Oct. 2020
EC no.: 695-595-2
Molecular formula: C7H6N2O2
Molecular weight: 150.13 g/mol
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of Experimental Pharmacology and Toxicology, Center of Experimental Medicine of the Slovak Academy of Sciences, Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Fasting period before study: yes. Animals were fasted prior to dosing (food but not water was withheld over-night)
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning. The room temperature was maintained within the range of 22±2 °C. The relative humidity will be 55±10 %. The light regime was set to a 12-hour light / 12-hour dark cycle. The sanitation was performed according to standard operation procedures.
- Diet (e.g. ad libitum): A standard laboratory food KKZ-P/M (UEFT CEM SAS) was available ad libitum.
- Water (e.g. ad libitum): The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodical monitored (including microbiological control) and recorded
- Acclimation period: The animals were acclimated to the condition identical to the condition during the experiment at least 5 days prior to the start of treatment. The acclimation was according to standard operation procedures.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Relative humidity (%): 55±10 %
- Air changes (per hr): central air-conditioning
- Photoperiod (hrs dark / hrs light): 12-hour light / 12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqua Pro Injectione Bieffe
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): Appropriate vehicle
- Justification for choice of vehicle: Ultra pure water such as API is a common vehicle for water soluble items in toxicity studies like OECD TG 423
- Lot/batch no. (if required): 19L1001
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. - Doses:
- 2000 mg/kg body weight, 300 mg/kg body weight and 50 mg/kg body weight
- No. of animals per sex per dose:
- 3 animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2 and 4 hours later. Each animal was inspected daily for the next 14 days.
Individual weights of animals were determined shortly before the test item administration and weekly thereafter. Weight changes after first and second week after administration were calculated and recorded.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behavioural patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality of 3/3 females at limit dose of 2000 mg/kg body weight and 3/3 females at the dose of 300 mg/kg body weight was observed.
All six female animals survived after administration at the dose of 50 mg/kg body weight. - Clinical signs:
- other: The test item 2-propyn-1-y1 1H-imidazole-1-carboxylate administered to 3 females Wistar rats at a limit dose of 2000 mg/kg caused slight immediate reaction (piloerection) and after two hours some somatomotor and coordination problems in two animals were r
- Gross pathology:
- No visible pathological findings other than hyperemia of liver were observed in Animals No. 1 - 3 dosed with 2000 mg/kg body weight and Animals No. 3 - 6 dosed with 300 mg/kg body weight.
No pathological findings in Animals No. 7 - 12 dosed with 50 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 of the test item 2-propyn-1-y1 1H-imidazole-1-carboxylate is greater than 50 mg/kg and lower than 300 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item 2-propyn-1-y1 1H-imidazole-1-carboxylate is classified GHS Category 3 with a LD50 cut off value 200 mg/kg body weight, after single oral administration to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item “2-propyn-1-y1 1H-imidazole-1-carboxylate” when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose.
In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all animals within 24 hours after administration. In a second step, 3 females were treated with dose of 300 mg/kg body weight. The test item in the dose of 300 mg/kg caused mortality of all animals within 48 hours after administration. In a third step, 3 females were treated with dose of 50 mg/kg body weight. The test item in dose 50 mg/kg did not cause death of animals and therefore another 3 females were treated 48 hours later at the same dose level. All animals survived at this dose level.
The test item 2-propyn-1-y1 1H-imidazole-1-carboxylate administered to 3 females Wistar rats at a limit dose of 2000 mg/kg caused reaction 1 hour after administration of test item (sleep behavior, somatomor discoordination). Within two hours Animal 1 died and after 4 hours died Animal 2. Animal 3 died within 24 hours. During necropsy we did not see any obvious pathological changes in gastrointestinal tract or other organs other than liver hyperemia.
Dose of 300 mg/kg of body weight caused slight reaction (piloerection). After 24 hours Animal 5 died and blood in the urine in Animal 4 was observed. Within 48 hours Animals 4 and 6 died. Autolytic processes were observed during necropsy of all animals at this dose level.
Dose of 50 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. During necropsy we did not observe any macroscopic findings in all Animals at this dose level.
The LD50 of the test item 2-propyn-1-y1 1H-imidazole-1-carboxylate is greater than 50 mg/kg and lower than 300 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item 2-propyn-1-y1 1H-imidazole-1-carboxylate is classified GHS Category 3 with a LD50 cut off value 200 mg/kg body weight, after single oral administration to Wistar rats.
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