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EC number: 211-694-1 | CAS number: 687-47-8
- 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:
- 1989-09-28 to 1995-08-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl (S)-2-hydroxypropionate
- EC Number:
- 211-694-1
- EC Name:
- Ethyl (S)-2-hydroxypropionate
- Cas Number:
- 687-47-8
- Molecular formula:
- C5H10O3
- IUPAC Name:
- ethyl 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material used in the report: ethyl lactate
- CAS number: 687-47-8 (confirmed by sponsor)
- Trade name: Purasolv EL
- Batch number: EA 0188F
- Appearance: liquid
- Purity: 99.5%
- Storage: at room temperature, in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals Çharles River Wiga GmbH", Sulzfeld, F.R. Germany.
- Age at study initiation: 5 weeks.
- Weight at study initiation: males: 139-158 g; females: 126-141 g.
- Fasting period before study: overnight.
- Housing: Groups of five animals, males and females separated in stainless cages either wire-screen bottom and front.
- Diet (e.g. ad libitum): The Institute's cereal-based, open-formula basal diet for rats was fed to the animals ad libitum during the quarantine and study periods except for fasting prior to dosing.
- Water (e.g. ad libitum): Tap water was freely available at all times by means of an automatic watering system.
- Acclimation period: The rats were kept under the environmental conditions of the Institute's animal house for an acclimatization period of about 1 week prior to the test.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C.
- Humidity (%): 30-70%.
- Air changes (per hr): about 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test substance was diluted with water in a concentration of 20% (w/v). The test dilution was given by gavage, in one single dose of 10 mL/kg body weight to five male and five female rats.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- A preliminary study was carried out to find the general level of acute toxicity for the test substance.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and later on, at least once daily, throughout an observation period of 14 days. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: At the end of the observation period, the rats were killed with carbon dioxide for macroscopic examination. - Statistics:
- Since no mortality occurred a LD50 could not be calculated; a LD50 exceeding 2000 mg/kg bw was given as a result.
Results and discussion
- Preliminary study:
- A prelimary study was carried out to find the general level of acute toxicity of the test substance; data of this preliminary study were not presented in the report.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occcurred
- Clinical signs:
- other: At 1, 4 and 24 hours after treatment all animals showed moderate signs of piloerection. These signs of intoxication were not observed 48 hours after treatment and thereafter.
- Gross pathology:
- Macroscopic examination at the end of the observation period did not reveal any treatment-related gross alteration.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- In an acute oral toxicity study in rats conducted according to OECD Test Guideline 401, no mortality occurred at the limit dose of 2000 mg/kg bw. Based on the results and in accordance with OECD Guideline 401, the oral LD50 was determined to be greater than 2000 mg/kg bw in both male and female rats.
- Executive summary:
In an acute oral toxicity study conducted according to OECD Test Guideline 401, groups of Wistar rats (n= 5/sex) were given a single oral dose of Ethyl (S)-lactate (purity: 99.5%) in water at a dose of 2000 mg/kg bw and were observed for 14 days. All animals survived until the end of the study. At 1, 4 and 24 hours after treatment all animals showed moderate signs of piloerection. These signs of intoxication were not observed 48 hours after treatment and thereafter. All animals gained weight after 3 days and thereafter. At necropsy, no treatment-related macroscopic findings were observed in any animal.
Based on the results the LD50 value was determined to be greater than 2000 mg/kg bw. Therefore, classification for acute oral toxicity according to the CLP Regulation 1272/2008 is not warranted.
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