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Diss Factsheets
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EC number: 201-317-9 | CAS number: 81-04-9
- 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:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP japanese study which did not follow an OECD guideline.
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the Absorption, Excretion, Distribution and Metabolism of (2-Acetyllactoyloxyethyl)trimethylammonium 1,5-naphtalenedisulfonate (TM-723)
- Author:
- Nakashima, Y. et al.
- Year:
- 1 979
- Bibliographic source:
- Oyo Yakuri. Sendia. Vol 18, ISS 5, 1979, 723-748
Materials and methods
- Objective of study:
- other: ADME
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The absorption, excretion, distribution and metabolism of 2-acetyllactoyloxyethyl)trimethylammonium-1,5-naphtalendisulfonate (TM-723) was studied in rats and mice with 14C and 3H-labelled derivates of the compound and its potentially possible metabolites after intravenous, subcutaneous and peroral administration. Results of the tritium labelled sodium salt of 1,5-naphtalenedisulfonate and the tritium labelled 2-Acetyllactoyloxyethyl)trimethylammonium salt of 1,5-naphtalenedisulfonate are presented in the following.
- GLP compliance:
- no
Test material
- Reference substance name:
- Naphthalene-1,5-disulphonic acid
- EC Number:
- 201-317-9
- EC Name:
- Naphthalene-1,5-disulphonic acid
- Cas Number:
- 81-04-9
- Molecular formula:
- C10H8O6S2
- IUPAC Name:
- naphthalene-1,5-disulfonic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Unspecified test material
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- (3H-naphtalenedisulfonate)TM-723 (named 3H-TM-723) and (3H-sodium-naphtalenedisulfonate)TM-723 (named 3H-TM-723D-Na)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: intravenous, subcutaneous, peroral
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
12.7 mg/kg bw (3H-TM-723D-Na) and 25 mg/kg bw (3H-TM-723)
- No. of animals per sex per dose / concentration:
- No data
- Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- After oral administration of 12.7 mg/kg bw 3H-TM-723D-Na (p.o.) low blood level (<1µg/mL) were reported compared to intravenous (i.v.:~12 µg/mL) and subcutaneous (s.c) application (maximum 5 µg/mL within 0.75 h). Blood level after i.v. and s.c. application decreased to below 1 µg/mL within 2 h indicating rapid tissue distribution or elimination. Excretion after i.v. and s.c application was mainly via urine (>90% within 24 h) while excretion via urine after p.o. application was only 14.5% within 24 h (14.8% within 120 h) for 3H-TM-723D-Na and 16.9% within 24 h (18.3% within 120 h) for 3H-TM-723. After oral application the majority was excreted via feces (85.3% for 3H-TM-723D-Na and 82.0% for 3H-TM-723). Thus, the low blood level and the lower excretion rate in urine after oral application indicate an incomplete absorption of the sodium and the 2- acetyllactoyloxyethyl)trimethylammonium salt of 1,5-naphtalenedisulfonic acid (Armstrongs acid).
- Details on distribution in tissues:
- Residual radioactivity (3H-TM-723D-Na) was predominantly found in the kidney after intravenous (10 minutes) and subcutaneous (30 minutes) application of the radiolabeled test material. In addition, residual radioactivity was also present in lower amount in blood plasma and liver (10 min i.v. and 30 min s.c.). Nevertheless, residual radioactivity could be detected in low extent in more or less almost all tissues within 10 min after i.v. and 30 min after s.c. application of the test material indicating rapid tissue distribution. Peroral application revealed only very limited residual radioactivity (60 minutes) in some tissues (kidney, liver, heart, lung, blood and plasma) compared to i.v. and s.c. application of the test material indicating low oral absorption. Moreover, tissue accumulation is not likely. Pregnant rats administered with radio-labelled 3H-TM-723D-Na (i.v.) showed a similar tissue distribution pattern compared to non-pregnant rats after 10 and 60 minutes. Residual activity was mainly detected in kidney, maternal plasma, blood, liver, stomach and ovarium 10 minutes after application of the test material indicating rapid tissue distribution. In addition, residual radioactivity was also recorded in placenta, amniotic fluid, fetus (liver, kidney, GI tract) indicating that 3H-TM-723D-Na passes the placenta barrier.
- Details on excretion:
- The absorbed radioactivity was predominately excreted with the urine, accounting for >90% (i.v.) and >95% (s.c.) within 24 hours after administration of the radiolabeled test material. Very low amounts of the absorbed radioactivity were excreted with the feces, accounting for less than 4% (i.v.) and 2.2% (s.c.) within 24 hours after administration of the test material. In contrast, the major part of the radioactivity (approximately 81% of administered dose) was excreted with the feces within 24 hours after peroral (p.o.) administration of the radio-labeled test material, whereas only 15% of the absorbed radioactivity was excreted with the urine at the same time, indicating only limited absorption of the administered test material. After 5 days the complete dose was excreted, accounting totally for 99.7% (i.v.), 101.6% (s.c.) and 100.1% (p.o.) of the administered dose in rats, respectively. Biliary excretion of 3H after i.v. and p.o. application of 3H-TM-723D-Na was low (0.5 and 0.14% of applied dose, respectively).
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
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