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EC number: 423-800-5 | CAS number: 7305-71-7
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-amino-5-methylthiazole
- EC Number:
- 423-800-5
- EC Name:
- 2-amino-5-methylthiazole
- Cas Number:
- 7305-71-7
- Molecular formula:
- C4 H6 N2 S
- IUPAC Name:
- 5-methyl-1,3-thiazol-2-amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Chbb:THOM (SPF)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% Natrosol 250 HX® (Hydroxyethykellulose)
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- other: NOTEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The 4 weeks oral administration of AMTH to albino rats resulted in a marked lowering of the thyroid function (hypothyroidism) in the animals
treated with 100 mg/kg, indicated also in the 20 mg/kg group. The changes normalized largely within the treatment-free recovery period.
Taking in aeeount all the findings mentioned above the NOTEL (No observed toxie effeet level) in the present trial is 4 mg/kg. - Executive summary:
Objective:
The aim of this study was to assess the speetrum of side-effeets, to identify target organs and to estimate the no toxie effect level of AMTH, a starting material of Meloxicam (UH-AC 62 XX), following repeated oral administration of graduated doses to rats. This investigation was required by law (Chemikaliengesetz [Chemical act], 2nd amendment of July 29, 1994).
Design of the study: Four weeks administration of AMTH suspended in hydroxyethylcellulose (Natrosol 250 HX) in dosages of 0 (control; Natrosol, GO), 4 (G 1), 20 (G 2) and 100 mg/kg (G 3) to 5 Wistar rats per dose and of eat:h sex via gastric tube. In the control and the high dose group, 5 m/5 f animals were additionally inserted for a 2 weeks recovery period, prolonged to 0 weeks during the study.
Materials and methods:
Test compound: AMTH (2-Amino-5-Methylthiazol), batch no. 141038
Anirnals: 60 rats (30 males, 30 females), Chbb:Thom (SPF)
Age at study start: 43 days
Body weight at study start: males 208.6-231.0 g, females 100.1-178.8 g
Study period: May 14-July 22, 1996
Main results:
No animal died during the study. Sedation was observed in the 20 and 100 mg/kg treated animals, in the latter one initially with prone position and dacryorrhea. The high dose (100 mg/kg) rats showed additionally rough eoat during the entire administration period. All symptoms disappeared during the recovery period. Body weight gain and food t:onsumption were decreased in the high dose group (100 mg/kg) during the administration period. In the mid dose group, the food intake was slightly lowered in the first administration week.
Changed hematological values in males and/or females were evident mainly in the high dose group in form of decrease in hemoglobin, erythrocyte count, hematocrit, reticulocytes, total leucocyte count (especially lymphocytes) and thrombocyte count. The thromboplastin time was elevated. Erythrocytes were also decreased in the 20 mglkg females. Among the clinical chemistry parameters ofthe high dose (100 mg/kg) group, slightlyelevated values were observed in LAP, bilirubin (males), total cholesterol, cholinesterase (males), BUN, creatinine and total protein (albumin and globulin). Glucose, total glycerol (males) and inorganic phosphate levels were slightly decreased in this group. All changed hematological and clinical chemistry values were largely normal after the 6 weeks treatment-free recovery period. Organ weight changes were mainly observed in the high dose group (100 mglkg). Weight decrease occurred in heart, thymus (also the 20 mglkg males), spleen, and adrenals (females only) and was of mild character. Strong weight increase was evident in thyroids. Lungs and pituitary of the high dose males were slightly elevated in weight. Apart from sporadic spontaneous changes, there were no gross pathological findings evident among the substancetreated grou ps. Test substance-related histopathological organ changes were found in the thyroid, pituitary, adrenals, thymus, liver, spleen and lungs of animals of the mid (20 mglkg) and high dose (100 mglkg) group. The macroscopically enlarged thyroids showed diffuse hypertrophy and hyperplasia of the follicle epithelium with reduced colloid content as the typical picture of hypothyroidism. This change disappeared during recovery period. At this time point, the organ showed a hyperactive appearance. The acidophilic-to-basophilic cell ratio ofthe adenohypophysis was inverted. The adrenal cortex of the high dose males was slightly atrophic. The thymus showed premature involution with reduction of all cell populations. In the lungs slightly increased foam cell aggregation was observed. This change was only weak and is therefore not regarded to be responsible for weight increase of this organ. Slight hypertrophy ofthe centrolobular hepatocytes was observed in high dose rats, most probably due to enzyme induction. The splenic red pulp was collapsed because of depletion of blood cells.
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