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EC number: 600-039-9 | CAS number: 10023-48-0
- 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: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic toxicity and teratological test of thiamine monophosphate disulfide
- Author:
- Hori et al.
- Year:
- 1 965
- Bibliographic source:
- J Vitaminol 12:42-48
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: The test substance was administered intraperitoneally for 6 months to male Wistar rats.
- Parameters analysed / observed: Body weight, organ weights, food intake, clinical signs, haematological findings and gross pathology - GLP compliance:
- no
Test material
- Reference substance name:
- disulfanediylbis[(2Z)-2-{[(4-amino-2-methylpyrimidin-5-yl)methyl](formyl)amino}pent-2-ene-3,5-diyl] bis[dihydrogen (phosphate)]
- Cas Number:
- 992-46-1
- Molecular formula:
- C24H36N8O10P2S2
- IUPAC Name:
- disulfanediylbis[(2Z)-2-{[(4-amino-2-methylpyrimidin-5-yl)methyl](formyl)amino}pent-2-ene-3,5-diyl] bis[dihydrogen (phosphate)]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar-King
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Approximately 110 g
- Housing: Animals were indiviudally housed.
- Diet: Solid diet of CA-1 (Central Laboratories for Experimental Animals, Tokyo, Japan), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 - 60
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: 1.5% sodium bicarbonate in water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 6 months
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on an acute toxicity study in mice a LD50 of 6 g/kg bw was determined after intravenous administration, thus it was suggested that the toxicity was very low.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: Twice a week
FOOD CONSUMPTION: Yes, for 6 days once a month
HAEMATOLOGY: Yes
- Parameters checked: Number of erythrocytes, number of leucocytes and haemoglobin value - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organs checked and weighed: Liver, heart, spleen, kidney, adrenal gland and testes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 4/20, 3/20 and 4/20 animals of the control, low- and high-dose group, respectively, that died, had lusterless hair and a bloody nose. According to the authors the animals died of pneumonia.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Control: 4/20 animals died of pneumonia
50 mg/kg bw/day: 3/20 died of pneumonia and 1/20 animals died due to an error during dosing by injection
100 mg/kg bw/day 4/20 died of pneumonia and 1/20 animals died due to an error during dosing by injection - Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The animals that died, had a reduced body weight (no further details were given).
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A parasitic infection by Cysticerus fasciolaris and the pathological change due to pneumonia were observed in all dose groups including control group. According to the authors, the high percentage of blood aborption in the lymph sinus of the mesenteric lymph-node was considered to be caused by the bleeding following intraperitoneal injection due to the hemorrage. This effect was not considered to be toxicologically relevant (please refer to Table 1 under "any other information on results incl. tables").
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A case of hypertrophy in the perihepatic membrane was seen in the high-dose group, but no degeneration of hepatic parenchyma was found. According to the authors this effect was considered to be caused by minor irritation and the physical stimulation during the injection (please refer to Table 2 under "any other information on results incl. tables").
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No adverse effects observed up to and including the highest tested dose of 100 mg/kg bw/day
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
Table 1: Pathological findigns
Dose level (mg/kg bw/day) | Pathological findings | Number of pathological cases / Number of animals |
Control | Parasitism of Cysticercus | 2/16 |
Control | Partial change of pulmonary lobe | 1/16 |
50 | Parasitism of Cysticercus | 3/16 |
50 | Partial change of pulmonary lobe | 1/16 |
100 | Parasitism of Cysticercus | 4/15 |
100 | Partial change of pulmonary lobe | 2/15 |
100 | Congestion of the adrenal medulla | 1/15 |
100 | Partial fibrin sedimentation of hepatic capsula | 1/15 |
Table 2: Histopathological findings
Dose level (mg/kg bw/day) | Histopathological findings | Number of histopathological cases / Number of animals |
Control | Blood absorption in mesenteric lymphnodes | 10/16 |
Control | Infiltration of lympho- and monocytes in heart interstitium | 1/16 |
Control | Infiltration of lympho- and monocytes in hepatic Glisson sheath | 1/16 |
Control | Mild fatty infiltration in the liver | 1/16 |
Control | Infiltration of lympho- and monocytes in kidney | 1/16 |
Control | Atrophy of splenic medulla | 1/16 |
Control | Mild catarrhal pneumonia | 3/16 |
50 | Blood absorption in mesenteric lymphnodes | 12/16 |
50 | Mild catarrhal pneumonia | 2/16 |
50 | Infiltration of lympho- and monocytes below the pericardium | 1/16 |
50 | Infiltration of lympho- and monocytes in hepatic Glisson sheath | 2/16 |
50 | Mild fatty infiltration in the liver | 1/16 |
100 | Blood absorption in mesenteric lymphnodes | 12/15 |
100 | Infiltration of lympho- and monocytes in mycocardium | 1/15 |
100 | Infiltration of lympho- and monocytes in hepatic Glisson sheath | 1/15 |
100 | Hypertrophy of hepatic capsule | 2/15 |
100 | Mild fatty infiltration in the liver | 2/15 |
100 | Mild catarrhal pneumonia | 2/15 |
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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