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A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
EC number: 406-870-1 | CAS number: 115100-55-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 19, 1990 to October 18, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
- EC Number:
- 406-870-1
- EC Name:
- A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
- Cas Number:
- 115100-55-5
- Molecular formula:
- not applicable
- IUPAC Name:
- triiron(3+) nonasodium 2-(2-{4-hydroxy-2-oxido-5-[2-(3-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate 2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-2-hydroxy-4-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate tris(2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-4-hydroxy-2-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate) 2-{2-[4-hydroxy-5-(2-{4-[(4-nitro-2-sulfophenyl)amino]phenyl}diazen-1-yl)-2-oxidophenyl]diazen-1-yl}-4,6-dinitrobenzen-1-olate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: BRL Ltd., Basel, Switzerland
-Females (if applicable) nulliparous and non-pregnant: [yes/no]
-Age at study initiation: Approx. 8-9 weeks
-Weight at study initiation:
males; 179 - 203 g
females: 154 - 201 g
-Fasting period before study: Feed was withheld overnight prior to dosing until approxlmately 3-4 hours after administration of the test substance.
-Housing: Group housed, five per sex to a cage, using polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by Broekman Instltute, Someren, The Netherlands).
-Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland).
-Water (e.g. ad libitum): Free access to tap-water.
-Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21 ± 3 °C
-Humidity (%): 40-70 %
-Air changes (per hr): 15 air changes per hour
-Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
-Amount of vehicle (if gavage): 20 ml/kg body weight (Group 1 ), 10 ml/kg body weight (Group 2 and 3 ) - Doses:
- Group 1: 5000 mg/kg body weight.
Group 2: 2800 mg/kg body weight.
Group 3: 1580 mg/kg body weight - No. of animals per sex per dose:
- 5 per sex per doses
- Control animals:
- no
- Details on study design:
- -Duration of observation period following administration: 14 days
-Frequency of observations Mortality / Viability: At periodic intervals on the day of dosing (day 1) and twice dally thereafter for 14 days
-Frequency of observations and weighing: Test days 1 (pre-administration), 8 and 15.
-Necropsy of survivors performed: yes
All animals killed for humane reasons or animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation and subjected to necropsy. All animals assigned to the study were subjected to necropsy.
The necropsies were performed by experienced prosectors and descriptions of all macroscopic abnormalities recorded.
-Other examinations performed: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days.
All signs of reaction to treatment were recorded with particular attention paid to changes in the skin, fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsion, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- The LD50 value for females alone and the slope of the dose mortality curve were estimated using the Maximum likelihood method (Finney, O.G. Probit Analyses, 3rd Edn., London, Cambridge, University Press, 1971).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 047 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 4 females rats are dead within 24 hours of dosing.
- Clinical signs:
- Signs of systemic toxicity observed during the study period in each dose group were as follows:
5000 mg/kg body weight: Piloerection, lethargy, hunched posture, ataxia, alopecia
2800 mg/kg body weight: Piloerection, lethargy, alopecia
1580 mg/kg body weight: No abnormities
All surviving animals had recovered by day 4.
All females found dead showed body weight loss on the day of death. All surviving animals showed body weight gain over the study period. - Gross pathology:
- Macroscopic post mortem examination of the animals that died during the study or surviving animals at termination did not reveal any histopathological changes that were considered to have arisen as an effect of treatment. Minor changes noted in each group were:
5000 mg/kg body weight: Black/brown stomach contents, dilatation of the renal pelvis
2800 mg/kg body weight: Dilatation of the renal pelvis
1580 mg/kg body weight: No abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP regulation (EC) no. 1272/2008
- Conclusions:
- The oral LD50 values for male and female rats combined or for males separately were estimated as exceeding 5000 mg/kg. The estimated LD50 value for females alone was 4047 mg/kg.
- Executive summary:
The purpose of this study was to assess the toxicity of the test article when administered to rats as a single oral dose.
The study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 84/449/EEC, Part B.1, "Acute Toxicity-Oral".
The substance was administered by oral gavage to five rats of each sex per group, at 5000 mg/kg body weight. As 4 females died during the study period 2 additional groups, each comprising of 5 females, were dosed at 2800 or 1580 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period. Four females receiving 5000 mg/kg body weight died within 24 hours of dosing. No mortalities occurred during the study period among males receiving 5000 mg/kg or females receiving 2800 or 1580 mg/kg.
Signs of toxicity noted among animals receiving 5000 or 2800 mg/kg included piloerection, lethargy, hunched posture, ataxia and alopecia. Females receiving 1580 mg/kg showed no changes in clinical appearance. Females found dead on day 2 showed body weight loss. All surviving animals showed body weight gain over the study period. Macroscopic post mortem examination of animals found dead or surviving animals at termination did not reveal any abnormalities that were not commonly noted among rats of this age and strain or that were considered toxicologically significant.
The oral LD50 values for male and female rats combined or for males separately were estimated as exceeding 5000 mg/kg. The estimated LD50 value for females alone was 4047 mg/kg. Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC, Annex VI of the EEC Directive 67/548/EEC), the substance cannot be classified and has no obligatory labelling requirement.
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