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EC number: 609-496-9 | CAS number: 379685-94-6
- 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:
- From 13 August 2002 to 30 December 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 17th July 1992
- Deviations:
- yes
- Remarks:
- One animal of the main test received by mistake a dose-volume of 2.5 mL/kg, instead of 2.05 mL/kg (dose received of 2475 mg/k. This minor deviation was not considered to have compromised the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 31st July 1992
- Deviations:
- yes
- Remarks:
- One animal of the main test received by mistake a dose-volume of 2.5 mL/kg, instead of 2.05 mL/kg (dose received of 2475 mg/k. This minor deviation was not considered to have compromised the validity or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester
- EC Number:
- 609-496-9
- Cas Number:
- 379685-94-6
- Molecular formula:
- C18H23F3N2O4
- IUPAC Name:
- Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Other: ochre fine powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Rj: SD (IOPS Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Janvier, Le Genest-Saint-IsIe, France.- Females (if applicable) nulliparous and non-pregnant: yes- Age at study initiation: approximately 6 weeks old- Weight at study initiation: 198 ± 9 g for the males and 164 ± 3 g for the females- Fasting period before study: ovenight period of approximately 18 hours before dosing, and during the 4 hours after administration of the test item. - Housing: animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and one rat (sighting test) or five rats of the same sex (main test) during the treatment period. Each cage contained autoclaved sawdust (SICSA, Alfortville, France). Sawdust was analysed by the supplier for composition and contaminant levels. - Diet: free access to A04 C pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France), except during the fasting period and the 4 hours following the test material administration. Each batch of food was analysed by the supplier for composition and contaminant levels. The diet formula was provided in the study report.- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of water are performed regularly by extemal laboratories (include detection of possible contaminants (pesticides, heavymetals and nitrosamines)). - Acclimation period: at least 5 days ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 2°C - Humidity (%): 30 to 70% - Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air. - Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 0.5% suspension of methylcellulose in purified water (prepared at the testing laboratory by reverse osmosis)
- Details on oral exposure:
- VEHICLE - Lot/batch no. (if required): 80K1020 (Sigma, Saint-Quentin-Fallavier, France) MAXIMUM DOSE VOLUME APPLIED: 10mLkgOn thé day of treatment, thé test item was ground using a mortar and pestle, then was prepared at thé chosen concentration in thé vehicle. DOSAGE FORM PREPARATION: On the day of treatment, the test item was ground using a mortar and pestle, and was then prepared at the chosen concentration in the vehicle. All preparations were made freshly on the morning of administration by the testing laboratory pharmacy and any unused material was discarded that same day.ADMINISTRATION OF THE TEST SUBSTANCE: The volume administered to each animal was adjusted according to body weight determined on the day of treatment.
- Doses:
- 500 and 2000 mg/kg bw for the sighting test2000 mg/kg bw for the main test
- No. of animals per sex per dose:
- One female per dose level for the sighting test5 male and 5 females for the main test
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days for the sighting test and 14 days for the main test - Frequency of observations and weighing: During the hours following treatment, animals were frequently observed. Then, at least once a day for 7 days (sighting test) or 14 day (main test) . All rats were weighted just before administration of the test item on day 1, and then on days 8 and 15.The body weight gain of the treated animals was compared to that of CIT control animals with a similar initial body weight.- Sacrifice: by CO2 asphyxiation - Necropsy of survivors performed: yes, as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. No organ samples were taken.
- Statistics:
- not applicable
Results and discussion
- Preliminary study:
- Dyspnea and piloerection were observed on day 1 in the animal given 500 mg/kg bw.No clinical signs and no mortality were observed at the 2000 mg/kg dose level.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality, no significant clinical signs and no macroscopic findings
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Piloerection was observed on day 1 in all animals.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test material is higher than 2000 mg/kg body weight without mortality, significant clinical signs or macroscopic findings. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the acute oral toxicity of the test material, according to OECD Guideline 420 (dated July 17th, 1992) and EU method B.1 bis of the E.E.C. directive n° 92/69 (dated July 31st, 1992).
Material and methods
The test material -prepared in a 0.5% suspension of methylcellulose- was administered by gavage to a group of 10 Sprague Dawley rats (5 males and 5 females) at the dose of 2000 mg/kg body weight. This dose was chosen based on the results of a preliminary test (sighting test) where the doses of 500 and 2000 mg/kg body weight were administered to female rats (one per dose group).
Animals of the main test were monitored at least once a day for 14 days. All rats were weighted just before administration of the test item on day 1, and then on days 8 and 15. Necropsies were performed on all the animals.
Results
No mortalities or significant clinical signs were recorded during the study. Only piloerection was observed on day 1 in all animals. The body weight gain of the treated animals was not affected by the treatment with the test material. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related change.
Conclusion
Under the experimental conditions of this study, the oral LD50 of the test material is higher than 2000 mg/kg body weight without mortality, significant clinical signs or macroscopic findings. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
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