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Diss Factsheets
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EC number: - | CAS number: 42355-78-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test procedures cannot be subsumed under a testing guideline, nevertheless are well documented and scientifically acceptable. Justification for Read Across is detailed in the Toxicokinetics summary and in the Category Justification Report attached to the section 13.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
- Reference Type:
- publication
- Title:
- Metabolic Behaviour of Water-Soluble Fluorescent Whitening Agents in the Rat and Bean Plant.
- Author:
- W. Muecke, G. Dupuis, H.O. Esser
- Year:
- 1 975
- Bibliographic source:
- Environmental Quality and Saftety, Supplement, Vol 4, 174-179.
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- The fate of 14C-labeled test substance (TS) was followed in the rat. An oral dose of approximately 5 mg/kg was administered to animals. Faeces, urine and expired CO2 were collected separately at predetermined time intervals for analysis. The animals were killed by decapitation 96 hours after dosing.
- GLP compliance:
- no
- Remarks:
- Pre GLP.
Test material
- Reference substance name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 237-600-9
- EC Name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 13863-31-5
- Molecular formula:
- C38H40N12Na2O8S2
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- C14
Test animals
- Species:
- rat
- Strain:
- SIV 50
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas, Kisslegg, Germany.
- Weight at study initiation: average was 229 ± 14 g.
- Housing: kept separately.
- Individual metabolism cages: yes, all-glass metabolism cages.
- Diet: commercial rat food (Nafag No. 185, Nafag, Gossau, Switzerland).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS
Test substance was dissolved in water and approx. 0.5 ml of solution was administered. - Duration and frequency of treatment / exposure:
- Once.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5.23 ± 0.05 mg/kg
- No. of animals per sex per dose / concentration:
- 4 males and 4 females.
- Details on study design:
- The animals were killed by decapitation 96 hours after dosing.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY
- Sampling in life: faeces, urine and expired CO2 were collected separately at predetermined time intervals for analysis.
- Tissues sampled: samples of blood, liver, kidney, brain, muscle and fat were collected for analysis.
- Time and frequency of sampling: tissues and blood after 96 hours. - Statistics:
- Excretion half-life times were calculated from the net rate coefficient of drug elimination using the 24-hour excretion values.
The limit of quantitative determination was calculated according to C.A. carrie (Ami. Chem. 40, 596, (1968) ).
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The results indicate that test substance is not absorbed from the gut of the rat and probably passes through the gut tightly bound to cellulose in the gut contents. The rate of excretion is probably only dependent on the rate at which the gut contents pass through the gastro-intestinal tract.
- Details on distribution in tissues:
- The average residue in all tissues of both sexes was less, than 0.005 ppm test substance equivalents (limit of quantitative determination).
- Details on excretion:
- More than 90% of the administered radioactivity was excreted within 48 hours of dosing. The faeces being the main, and practically only route of elimination.
Little or no radioactivity was found in the urine and expired air.
The faeces were lyophilized, ground to a fine powder, and exhaustively extracted in a Soxhlet apparatus,first with methanol and second with water. Practically no radioactivity was extracted with these solvents. This is not entirely supprising as this compound is known to bind very tightly to cellulose and is probably bound to the same substance in the rat faeces.
Any other information on results incl. tables
Excretion of Radioactivity by Rats after an oral Dose of approximately 5 mg/kg 14C-test substance
Excretion | ||
Males; n = 3* | Females, n = 4 | |
Faeces | ||
0 - 24 h | 74.8 ± 10.6 | 83.9 ± 9.0 |
24 - 48 h | 18.1 ± 10.5 | 11.2 ± 7.1 |
48 - 72 h | 0.4 ± 0.2 | 0.3 ± 0.2 |
72 - 96 h | 0 | 0.1 ± 0.1 |
Subtotal |
93.3 ± 6.2 | 95.5 ± 2.8 |
Urine | ||
0 - 96 h | 93.3 ± 6.2 | 95.5 ± 2.8 |
Expired Air | ||
0 - 72 h | < 0.01 | < 0.01 |
Cage wash | 0.04 ± 0.02 | 0.3 ± 0.2 |
Total Recovery | 93.6 ± 5.6 | 96.1 ± 2.7 |
Excretion half-life time (h) | 13.8 | 9.5 |
* The result from one male were excluded from table because of a dosing error.
Applicant's summary and conclusion
- Conclusions:
- After an oral dose of approximately 5 mg/kg nearly all the administered radioactivity was rapidly excreted with the faeces.
- Executive summary:
Method
The fate of 14C-labeled test substance (TS) was followed in the rat. An oral dose of approximately 5 mg/kg was administered to animals. Faeces, urine and expired CO2 were collected separately at predetermined time intervals for analysis. The animals were killed by decapitation 96 hours after dosing.
Result
After dosing nearly all the administered radioactivity was rapidly excreted with the faeces.
The average residue in all tissues examined was less than 0.005 ppm TS equivalents. Most of the radioactivity in the faeces was not extractable with either methanol or water. Probably because the compound is tightly bound to cellulose in the faeces.
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