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Diss Factsheets
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EC number: 222-158-1 | CAS number: 3373-59-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- L-TEE
- IUPAC Name:
- L-TEE
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Threonineethylester
- Analytical purity: 97%
- Purity test date: No data
- Lot/batch No.: 142-576-6
- Expiration date of the lot/batch: No data
- Stability under test conditions: Considered to be stable during testing
- Storage condition of test material: Frozen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:Wl(Glx/BRL/han)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: 285-319g (males), 178-194g (females)
- Fasting period before study: overnight prior to dosing
- Housing: suspended stainless steel mesh cages
- Diet (e.g. ad libitum): ad libitum, except overnight prior to dosing and three hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 or 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-70 % RH
- Air changes (per hr): 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily with flurorescent strip-lights
IN-LIFE DATES: From 11 April or 9 May 200 to 30 May 2000
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Purified water from on site Elgastat purifier.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Dispersed in purified water to reach 10/20 mL/kg bw
- Justification for choice of vehicle: solubility
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg (males) and 20 mL/kg (females)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose selection followed the Acute Toxic Class procedure detailed in EC and OECD guidelines. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at least daily, weighing on Day -1, 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,necropsy - Statistics:
- NA
Results and discussion
- Preliminary study:
- NA
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No clinical signs was observed
- Gross pathology:
- No macroscopic changes were observed for animals killed on Day 15.
- Other findings:
- - Organ weights: Not performed
- Histopathology: Not performed
- Potential target organs: None
Any other information on results incl. tables
At a first sight and based on read across to acute oral toxicity data on L-TEE, L-TME should not be considered to be an acute oral toxicant. However, as L-TME and L-TEE are small ester molecules, they may be expected to be easily hydrolysed by esterases in the body the acute toxicity may as well be determined by the product of hydrolysis. In that respect methanol should be considered much more toxic than ethanol in relation to human exposure.
For methanol toxicity, human data needs to be used, because rats are insensitive to the toxicity of methanol (ref. e.g. ECHA guidance on CLP criteria v4, November 2013, p282). In terms of human experience methanol is known to cause lethal intoxications in humans (mostly via ingestion) in relatively low doses (300-1000 mg/kg bw) (ref. e.g. ECHA guidance on CLP criteria v4, November 2013, p282). Using 300 mg methanol/kg bw as minimum lethal dose, the corresponding theoretical L-TME dose would be:
Mw of L-TME is 133 Dalton of L-threonine is 101 Dalton and methanol is 32 Dalton. Methanol part of L-TME constitutes approx. 24%. The corresponding oral lethal dose of L-TME assuming 100% hydrolysis to methanol and L-threonine would be 1250 mg/kg bw.
Thus from a precautionary view L-TME can according to the CLP-criteria for acute toxicity be classified as acute tox 4.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity of L-TEE was assessed in rats following a single administration of L-TEE. The study was performed in compliance with OECD guideline 423 and ECC guideline B1 tris. L-TEE was dispersed in purified water and administered at a dose volume of 10 (male) or 20 mL/kg (female). The acute oral median lethal dose (LD50) of L-TEE was estimated to be greater than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of L-TEE was assessed in rats following a single administration of L-TEE. The study was performed in compliance with OECD guideline 423 and ECC guideline B1 tris. L-TEE was dispersed in purified water and administered at a dose volume of 10 (male) or 20 mL/kg (female). The acute oral median lethal dose (LD50) of L-TEE was estimated to be greater than 2000 mg/kg bw.
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