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EC number: 413-550-5 | CAS number: 142068-96-0 H112339
- 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
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A written assessment of toxicokinetic behaviour is considered appropriate for the substance. The substance displays only minor toxicological effects in any of the studies proposed, and is deemed to be be not harmful for health effects. As such, it is deemed inappropriate in terms of animal welfare to conduct a toxicokinetic assessment when no harmful effects are predicted based on known toxicology. A written assessment has therefore been prepared to address this endpoint.
Data source
Materials and methods
- Objective of study:
- other: Assessment of toxicokinetic behaviour
- Principles of method if other than guideline:
- Written assessment based on toxicological profile.
- GLP compliance:
- no
Test material
- Reference substance name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- EC Number:
- 413-550-5
- EC Name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- Cas Number:
- 142068-96-0
- Molecular formula:
- Hill formula: C53H28Cl2N14Na8O26S8
- IUPAC Name:
- octasodium 5-[(4-chloro-6-{[4-({[4-chloro-6-({7-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-8-hydroxy-3,6-disulfonatonaphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}methyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Details on test material:
- Not applicable
Constituent 1
Test animals
- Species:
- other: Not applicable
Administration / exposure
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Not applicable
- No. of animals per sex per dose / concentration:
- Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Not applicable
- Details on dosing and sampling:
- Not applicable
- Statistics:
- Not applicable
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
Any other information on results incl. tables
The following information about the toxicokinetics were based on examination of the toxicological test package and knowledge known historically about reactive dyes. Independent experimental studies on the toxicokinetics was not done. Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form the essential toxicological profile of a substance. The assessment of the toxicokinetic properties of Substance H 112339 given below is based on the results obtained for the following toxicological endpoints;
Acute oral toxicity
Acute dermal toxicity
Skin irritation
Skin sensitisation
Ames Test – salmonella& E.coli
In Vitro Cytogenetic Assay in Human Lymphocytes
In vitro gene mutation test in CHO cells (HPRT Locus Assay)
Subacute (28-day) oral toxicity
Sub-chronic (90-day) oral toxicity study
All studies were carried out according to the principles of Good Laboratory Practice and met the requirements of the OECD and EU-Guideline for the Testing of Chemicals. Simultaneously reference to physico-chemical data such as solubility in solvents, log Pow and hydrolytic stability is included
General
The degree of purity of the substance is 70-80 %.Unknown byproducts of the dyestuff synthesis include water, salts and sulphonic acid organic derivatives, which are given as impurities.
Substance H 112339 is red powdered or granular solid at room temperature conditions. A vapour pressure determination performed and gave a value of <10-5 Pa at 25⁰C. Therefore a significant inhalation exposure to vapours is not expected. The low n-octanol/water partition coefficient (log Pow -5.7 at 20 ° C) as well as the relatively high molecular weight of the substance (>1600) a systemic bioavailability after dermal exposure is not anticipated.
Toxicological Profile:
Substance H 112339 was tested for acute oral toxicity in male and female Wistar rats. After application of 2000 mg/kg body weight by gavage, neither nor any clinical symptoms occurred. However, red staining of urine clearly indicates absorption and systemic availability of substance H 112339. Urinary excretion of Substance H 112339 being visualized by red staining of urine took about 4 days.
Based on the results of this study the median lethal dose (LD50) of Substance H 112339 in the rat is greater than 2 000 mg/kg body weight. Dermal treatment with 2 000 mg/kg body weight caused slight irritation and staining but caused no mortality or symptoms of toxicological relevance. Substance H 112339 is however irritating to the skin (but was reversible apart from staining) and is not a skin sensitiser in the Buehler test. According to the results of the acute dermal toxicity study as well as the skin irritation and sensitisation data and supported by the pronounced hydrophilic properties, Substance H 112339 most probably has no significant dermal absorptive potential.
Studies on genotoxicity (Ames-Test (ICJ CTL, 1991), in vitro cytogenetics (ICf CTL, 1992), in vitro HPRT-test (BASF AG, 2000)) were negative either with and without metabolic activation. Therefore, there is no indication of reactivity of Substance H112339 and its metabolites under the test conditions.
Most probably DNA reactive species are not formed in liver although liver enzymes lead to enhanced bacterial toxicity which suggests biotransformation activation of the substance.
In a 28-day study in rats with doses of 0, 50, 250 and 1000 mg/kg body weight given by gavage, clinical, clinico-chemical and histo-pathological effects observed in the 250 mg/kg and 1000 mg/kg groups also demonstrate absorption and systemic availability of Substance H 112339 (ICI Central Toxicology Laboratory, 1992) . In the 1000 mg/kg group (and in part also in the 250 mg/kg group), staining of tissues was observed at terminal and recovery kill. Since staining of tissues after two weeks of recovery is still present, excretion of Substance H 112339 being distributed in tissues appears to be rather slow. Staining of urine also indicates that renal excretion is a relevant pathway for the elimination of Substance H 112339.
In the 90-day study in rats, in which doses of 50. 250 and1000 mg/kg body weight were administered by gavage, clinical, clinico-chemical and (histo-)pathological effects were observed at all dose levels in females and at doses ≥ 250 mg/kg body weight with the kidneys being the main target organ (BASF AG, 2000). The results of this 90-day study confirm the statements on the toxicokinetic behaviour of Substance H 112339 in that:
a) Substance H 112339 is absorbed from the gastrointestinal tract and is systemically available in all tissues and organs
b) Substance H 112339 and its metabolites is - at least in part - excreted by the kidneys
In a 1-generation reproduction study in the rat, no effects on reproduction were noted, indicating that prolonged exposure is not expected to cause reproductive effects.
Evaluation :
Based on all available data, Substance H 112339 does not exhibit a conspicuous toxicokinetic behaviour. Substance H 112339 has a very low acute toxicity potential. The results from all studies with dermal exposure indicates that Substance H 112339 has insignificant or no dermal absorptive potential. Additionally, taking the results of the subacute and subchronic oral toxicity study into account, H112339 is absorbed from the gastrointestinal tract and is systemically available in all tissues and organs.
As such, a significant bioaccumulation potential in mammals can most probably be excluded, particularly given the low solubility in fat (0.009mg/100g fat), despite the observations in the studies. This conclusion is further endorsed by the effects of a bioaccumulation study in fish which clearly indicated that the substance is not bioaccumulated in this species (BCF < 3.3) Toxicity was further characterized by hypoplastic anemia with corroborating histopathological findings in spleen and bone marrow. Furthermore, as a consequence of severe systemic toxicity, also liver, ovaries, adrenal cortex, and serous coats were affected. By contrast, the discoloration of urine, feces, and/or skin was related to the tinctorial properties of the test substance (dye-stuff), but does not represent a toxicologically relevant finding.
The slight changes in kidney pathology and/or urinalysis of individual low dose females can be interpreted as remnants of transient tubular degeneration. The slight decrease in hematocrit in females of this dose level is assessed as being a mild adverse effect, only due to the lack of a histopathological correlate or other concomitant changes in red blood cells.
From the mutagenicity assays it appears that Substance H 112339 is not metabolised toward genotoxic structures.
Summary:
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Substance H 112339 . The data indicate that there is little or no dermal absorption. Although substance specific toxicity can be attributed to the material in prolonged exposure studies, significant bioaccumulation of Substance H 112339 can most probably be excluded due to the marked hydrophilic properties and lack of solubility in fat. Based on the negative mutagenicity assays, a metabolisation towards genotoxic sub-structures can be ruled out.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: no bioaccumulation potential based on review of study results
- Executive summary:
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Substance H 112339 . The data indicate that there is little or no dermal absorption. Although substance specific toxicity can be attributed to the material in prolonged exposure studies, significant bioaccumulation of Substance H 112339 can most probably be excluded due to the marked hydrophilic properties and lack of solubility in fat. Based on the negative mutagenicity assays, a metabolisation towards genotoxic sub-structures can be ruled out.
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