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EC number: 947-892-6 | CAS number: -
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Remarks:
- Elimination after intravenous administration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- excretion
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A solution of the radio-labeled substance was applied by intravenous administration and distribution in the body and excretion was measured up to 168 h
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name as used in the study report: Tinolux 4204
- Radiolabelling:
- yes
- Species:
- rat
- Strain:
- other: Tif:RIAf (SPF)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY animal farm
- Age at study initiation: 54 days
- Weight at study initiation: 250 g
- Housing: individually in metabolic cages
- Diet: NAFAG pellets No. 890
- Water: not specified
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS: not specified - Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Details on exposure:
- The substance was dissolved in 0.6 ml 0.9% NaCl-solution and injected into the tail vein; 2 mg/kg dose
- Duration and frequency of treatment / exposure:
- single injection
- Dose / conc.:
- 2 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- 2
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on study design:
- The animals were housed singly in metabolic cages constructed of stainless steel and glass and designed to separate urine and faeces. Urine was collected 6 h after dosing and thereafter urine and faeces were quantitatively collected daily up to 144 h and 168 h respectively.
Radioactivity was measured using a liquid scintillation counter by using the following procedures:
- Blood : 0.3 ml of blood was treated with 2 ml of a 1:1 mixture of IRGASOLV (CIBA-GEIGY) and isopropanol followed by the addition of 0.5 ml of 25% aqueous hydrogen peroxide. After 15 min at room temperature 0.5 ml of 2 N HCl and 16.5 ml of IRGASCINT A 300 (CIBA-GEIGY) were added.
- Tissues: Samples of up to 200 mg were left overnight with 2 ml of IRGASOLV at 40*'c, then 0.5 ml of 2 N HCl and 17.5 ml of IRGASCINT A 300 were added.
- Urine: Samples of 0.3 ml were diluted with 20 ml of IRGASCINT A 300 (CIBA-GEIGY Ltd.).
- Faeces: Faeces were homogenized after the addition of about the same amount of water, samples of 70-200 mg of the homogenates were left with 2 ml of a solution of 1:1 IRGASOLV in isopropanol for 4 h at 40 C, then 1 ml undiluted IRGASOLV was added and the mixture kept overnight at 40 C. After that 0.5 ml 2 N HCl and 16.5 ml IRGASCINT A 300 were added. - Statistics:
- Sample counts were corrected for quenching by means of an external calibration curve. They were expressed as concentrations of unchanged substance using the specific radioactivity of the labelled substance. This was determined for each sample series by simultaneously measuring standard samples of known concentrations. Sample counts equal to or less than Ib+ Δn (Δn calculated according the formula below [1]) were considered not to differ significantly from the background value Iband were not further processed.) Δn = 3 √ Ib(1/ts+ 1/ tb) [1] with Δn = detection limit (cpm); Ib= background (cpm); ts= sample counting time (min); tb= background counting time (min).
- Type:
- excretion
- Results:
- up to 168 h only 50% of the intravenously administered radioactivity was recovered with urine (15%) and faeces (35%) .
- Details on distribution in tissues:
- Highest concentrations were found in the liver (15.4 µg/g) and spleen (7.7 µg/g), the lowest ones in the blood and muscle (0.1µg/g) and the brain (0.02 µg/g) .
According to these concentrations 168 h after dosing about 46% of the dose was still in the body with the major fraction in the liver (35% of the dose). - Details on excretion:
- up to 168 h only 50% of the intravenously administered radioactivity was recovered with urine (15%) and faeces (35%) .
- Metabolites identified:
- not measured
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulations
- Specific details on test material used for the study:
- - Name as used in the study report: Tinolux 4204
- Radiolabelling:
- yes
- Species:
- guinea pig
- Strain:
- other: Tif:DHP
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY animal farm
- Age at study initiation:42-56 days
- Weight at study initiation: 310-410 g
- Housing: individually in metabolic cages
- Diet: standard guinea pig pellets - NAFAG No. 830
- Water: not specified
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS: not specified - Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- - first experiment: 30 minutes
- second experiment: 6 hours - Doses:
- 0.05 ml of an aqueous solution containing 1 mg of the substance was applied topically
- No. of animals per group:
- - Two animals in the group of 30 minutes exposure
- Three animals in the group of 6 hours exposure - Control animals:
- no
- Details on study design:
- 24 hours before topical application an area of 3.6 x 3.6 cm = 13 cm2 of dorsal skin was shaved to 1/20 mm hair length. Onto this area 0.05 ml of an aqueous solution containing 1 mg of the substance were applied evenly with a syringe. The application site was covered with a layer of OCLUFOL which was fixed with ISOELAST. In the first experiment (animal A and B) the occlusive dressing was removed 30 min after application. The dressing covering the treated area was cut off and placed in 1000 ml water. The unabsorbed preparation remaining on the surface of the skin at the application site was removed by wiping it off with ten 2 x 2.2 cm cellulose tissue swabs moistened with water, the swabs were extracted in the same water where the occlusive clothing was placed.
In the second experiment (animals C,D and E) the occlusive dressing was removed in the same way 6 h after application.
Radioactivity was measured using a liquid scintillation counter by using the following procedures:
- Blood : 0.3 ml of blood was treated with 2 ml of a 1:1 mixture of IRGASOLV (CIBA-GEIGY) and isopropanol followed by the addition of 0.5 ml of 25% aqueous hydrogen peroxide. After 15 min at room temperature 0.5 ml of 2 N HCl and 16.5 ml of IRGASCINT A 300 (CIBA-GEIGY) were added.
- Tissues: Samples of up to 200 mg were left overnight with 2 ml of IRGASOLV at 40*'c, then 0.5 ml of 2 N HCl and 17.5 ml of IRGASCINT A 300 were added.
- Urine: Samples of 0.3 ml were diluted with 20 ml of IRGASCINT A 300 (CIBA-GEIGY Ltd.).
- Faeces: Faeces were homogenized after the addition of about the same amount of water, samples of 70-200 mg of the homogenates were left with 2 ml of a solution of 1:1 IRGASOLV in isopropanol for 4 h at 40 C, then 1 ml undiluted IRGASOLV was added and the mixture kept overnight at 40 C. After that 0.5 ml 2 N HCl and 16.5 ml IRGASCINT A 300 were added.
Sample counts were corrected for quenching by means of an external calibration curve. They were expressed as concentrations of unchanged substance using the specific radioactivity of the labelled substance. This was determined for each sample series by simultaneously measuring standard samples of known concentrations. - Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- After an exposition time of 30 min and 6 h the excretion was about similar. Up to 168 h about 1% of the administered radioactivity was eliminated in the urine and about 5% in the faeces. Thus about 6% of the topically applied dose was absorbed through the skin. The elimination was slow and not finished after 168 h. 144 h and 168 h after administration a relatively large portion of the dose was still found in the skin at the application site. Results suggest that the amounts taken up by the skin are independent of the exposition time. The concentrations measured for blood, plasma, liver, kidney, muscle and white fat were at or below the significant detection limit. Measurable, but low 14C-concentrations of 0.01-0.08 ug/g were found in the liver. The mean of 0.042 µg/g corresponds to 0.05 % of the dose, calculated for a liver weight of 16 g.
- Key result
- Time point:
- 168 h
- Dose:
- 1 mg
- Parameter:
- percentage
- Absorption:
- ca. 6 %
- Remarks on result:
- other: Similar results were obtained for exposition times of 30 min and 6 h.
Referenceopen allclose all
The authors conclude that the absorption is 6% based on the amount excreted, but as can be observed in the same test using i.v. exposure within 168 hours only 50% of the test substance is excreted. As a result, the absorption would be around 12%.
Description of key information
Limited information is available on dermal absorption and on distribution and excretion of the substance.
A dermal absorption study was done in Guinea pigs (CIBA-GEIGY, 1982). Upon 168 h after topical administration of 14C-labelled substance to guinea pigs about 1% of the dose was found in the urine and 5% in the faeces. Thus about 6% of the topically applied substance was absorbed through the skin. Similar results were obtained for exposition times of 30 min and 6 h. In both experiments the amounts daily excreted with urine and faeces were about equal (ca. 1.3%) during the period of observation. This indicates that the substance was released from the skin depot at a low but constant rate. At 168 h after administration 14% of the dose was still found at the application site. Residual concentrations measured at 168 h in blood, plasma and tissues were at or below the limit of detection. The liver showed low but measurable 14C-concentrations (0.01-0.08 µg/g). In the same study, excretion of the substance after intravenous application in rats was studied (CIBA-GEIGY, 1982). After intravenous administration of 14C-labelled substance to rats radioactivity was very slowly eliminated from the body. Upon termination of the experiment (168 h) 50% of the dose was recovered with excreta, while the remaining fraction was found in the body. Highest 14C-levels were measured in the liver (15.4 µg/g), followed by spleen, adrenals, testes and bone marrow. The authors conclude that the dermal absorption is 6% based on the amount excreted, but as can be observed in the same test using i.v. exposure within 168 hours only 50% of the test substance is excreted. As a result, the dermal absorption would be around 12%.
No studies on inhalation or oral absorption are available. Both oral and intravenous acute toxicity studies are available for rat and mouse (CIBA GEIGY, 1979; CIBA-GEIGY, 1980; CIBA-GEIGY, 1981; CIBA-GEIGU, 1981). The LD50 for oral/rat is approximately 5581 mg/kg bw, while the intravenous LD50 for rat is approximately 828 mg/kg bw. For mouse, these values are > 6000 mg/kg bw oral and between 100 and 300 mg/kg bw intravenous. This indicates that the oral absorption is probably in the order of 3 to 15%. An inhalation study with one dose indicated that the LC50 for inhalation is > 1734 mg/m3 air (CIBA-GEIGY, 1980). Because no higher dose was studied, this cannot be used to obtain an indication of inhalation absorption via comparison with the intravenous LD50.
Key value for chemical safety assessment
Additional information
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