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Diss Factsheets
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EC number: 200-774-1 | CAS number: 72-19-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP range-finding study for OECD407 study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Guideline:
- other: dose-range-finding study for OECD Guideline 407 study
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- L-threonine
- EC Number:
- 200-774-1
- EC Name:
- L-threonine
- Cas Number:
- 72-19-5
- Molecular formula:
- C4H9NO3
- IUPAC Name:
- L-threonine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males 40-44 days, females 40-44 days
- Weight at study initiation: males 106.2-123.3 g, females 104.1-121.4 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxypropylmethylcellulose gel
- Details on oral exposure:
- The test substance was dissolved in 0.5% Methocel to the appropriate concentrations and was administered orally by gavage, at a constant volume of5 ml/kg b. w. daily for 14 days. The control animals received 5 ml vehicle/kg b. w. daily for 14 days in the same manner. The amount of the test
substance was adjusted to the animal's actual body weight daily. The test substance was freshly prepared every day. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- For each test substance that is mixed with a vehicle, tests by appropriate analytical method will be carried out for the main study (see LPT protocol
no. 16091 /02) to determine the concentration and stability of the test substance in the mixtures:
The analysis of the test substance-vehicle mixtures showed that the concentrations of the test substance-vehicle mixtures were in the range from 71.5% to 86.6% of nominal values after preparation. The slightly lower yields as expected ( 100% ± 20%) are probably related to analytical difficulties with the matrix Methocel. - Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- once daily, 7 days per week for 2 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
control: 5 mL vehicle/kg b.w./day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg b.w./day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
600 mg/kg b.w./day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg b.w./day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Rationale for dose selection:
The dose Ieveis for this preliminary study were selected in agreement with the sponsor based on available toxicity data.
Examinations
- Observations and examinations performed and frequency:
- Clinical signs:
Individual animals were observed at least once daily for any signs of behavioural changes, reaction to treatment or illness. lmmediately after
administration any signs of illness or reaction to treatment were recorded for each individual animal. Cageside observations included: general
appearance including changes in skin/fur, eyes, mucous membranes; respiratory and circulatory systems, somatomotor activity and behaviour
patterns. The onset, intensity and duration of any signs were recorded. ln addition, animals were checked regularly throughout the working day from 7.00 a.m. to 3.45 p.m. On Saturdays and Sundays animals were checked regularly from 7.00 a.m. to 11.00 a.m. with a final check performed at
approximately 1.00 p.m. Dated and signed records of appearance, change and disappearance of clinical signs were maintained on clinical history
sheets for individual animals.
Mortality:
Further checks were made early in each working day and again in the afternoon to Iook for dead or moribund animals. This allowed post mortem
examination to be carried out during the working period of that day. On Saturdays and Sundays a similar procedure was followed except that the
final check was carried out at approximately 1.00 p.m.
Body weight:
The body weight of each rat was recorded at the time of allocation of animals to groups, on the day of commencement of treatment and once a
week thereafter always on the same day of the week throughout the experimental period. - Sacrifice and pathology:
- On test day 15 (24 hours after the last test substance administration) all animals were sacrificed under ether narcosis by cutting the aorta
abdominalis, weighed, dissected and inspected macroscopically under the direction of a pathologist. All superficial tissues were examined visually
and by palpation and the cranial roof removed to allow observation of the brain, pituitary gland and cranial nerves. After ventral midline incision and skin reflection all subcutaneous tissues were examined. The condition of the thoracic viscera was noted with due attention to the thymus, lymph
nodes and heart. The abdominal viscera were examined before and after removal, the urinary bladder was examined externally and by palpation. Thegastro-intestinal tract was examined as a whole and the stomach and caecum were incised and examined. The lungs were removed and all pleural
surfaces examined under suitable illumination. The liver and the kidneys were examined. Any abnormalities in the appearance and size of the gonads, adrenals, uterus, intra-abdominal lymph nodes and accessory reproductive organs were recorded.
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality:
None of the rats died prematurely.
Clinical signs:
The treatment with 300, 600 or 1000 mg L-threonin/kg b.w./day for 2 weeks did not show any influence on behaviour and external appearance of rats. None of the rats died prematurely.
Body weight:
No test substance-related influence was observed on the body weight of the male and female rats treated with any of the tested dose Ieveis (300, 600 or 1000 mg L-Threonin/kg b.w./day).
Food and drinking water consumption:
No influence was noted on food intake for the male and female rats treated with either 300, 600 or 1000 mg L-Threonin/kg b.w./day. No test substance-related influence was noted on the drinking water consumption.
Macroscopic post mortem findings:
The macroscopic post mortem examination on test day 15 did not reveal any test substance-related findings in animals treated with 300, 600 or 1000 mg L-Threonin/kg b.w./day.
Applicant's summary and conclusion
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.
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