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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1991 to November 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in ocmpliance with GLP. No test guidlinee is specified within the study report; however the method is considered comparable to OECD Guideline 401.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- No details of test guidance referenced within the study report; however the method is equivalent to OECD Guideline 401.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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:
- The test sample (reference: NBY 405/74) was received as a dark brown powder. It was sent for testing from ICI Specialties, Blackley, Manchester, UK. A certificate of analysis (reference: 9103127 and dated 8 August 1951) stated that the test sample contained 71.6% (w/w) substance H112339 and 10.5% (w/w) moisture. From information supplied by the sponsor the test sample was used within the stated expiry date.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Specific pathogen free (SPF) Wistar-derived albino rats (Alpk:APfSD strain) were supplied by the Barriered Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK. The rats were young adults and at the beginning of the study they weighed 241-250g for males and 180-199g for females.
The rats were housed in suspended cages (37-5cm length x 32.5cm width x 23.0cm height). The cages were constructed of stainless steel, two sides being sheet and the remainder 14 standard wire gauge mesh. A maximum of five rats were housed in each cage and the sexes were kept separately.
The animals were allowed free access to food (Porton Combined Diet, Special Diets Services Ltd: Appendix A) and given unlimited access to water via an automatic system.
The room in which the rats were held was designed to maintain a temperature of between 19°C and 23°C and a relative humidity of 55±15%. Temperature and relative humidity were recorded constantly. The air-exchange system was designed to give 25-30 air-changes per hour and the light pattern was controlled by a time switch to give alternate periods of 12 hours of artificial light and 12 hours of darkness.
The rats were acclimatised to the animal laboratory for a minimum of six days prior to the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised
- Details on oral exposure:
- The test sample was given the CTL reference number Y07719/OQ1/001 and was tested as a preparation in deionised water.
The main study was preceded by a preliminary study (speculative oral study] in which a dose level of 2000mg/kg was tested on a small group of animals. Based on information from this study the dose-level for the main study was selected as 2000mg/kg. The dose level was adjusted to account for the moisture content, therefore a dose of 2234.6mg/kg test substance as supplied was administered which is approximately equal to 2000mg/kg of the test material excluding water. - Doses:
- 2000mg/kg body weight
- No. of animals per sex per dose:
- Five male and five female rats were used for this study.
- Control animals:
- no
- Details on study design:
- Five male and five female rats were used for this study. Each animal was given a number, unique within the study, using an ear-punch. Each animal was weighed and then fasted overnight for a period of up to 24 hours.
The main study was preceded by a preliminary study (speculative oral study] in which a dose level of 2000mg/kg was tested on a small group of animals. Based on information from this study the dose-level for the main study was selected as 2000mg/kg. The dose level was adjusted to account for the moisture content, therefore a dose of 2234.6mg/kg test substance as supplied was administered which is approximately equal to 2000mg/kg of the test material excluding water.
The rats were given a single oral dose of the test sample as a preparation in deionised water. A standard volume of 10ml/kg was dosed to each animal. The volume of the dose was calculated for each animal according to its weight at the time of dosing. The preparation was administered by gavage using a 12.5cm long plastic catheter attached to a sterile disposable plastic syringe of suitable size for the volume eg 2ml or 5ml.
The animals were observed for signs of systemic toxicity once within 2 hours of dosing and again between 4 and 7 hours after dosing. Subsequent observations were made once daily, or twice daily whenever there were significant signs of toxicity, up to day 15. The animals were weighed on the day before dosing (day -1), the day of dosing (day 1) and on day 3, day 4, day 8 and day 15.
At the end of the study, all of the animals were humanely killed by inhalation of excessive levels of halothane BP (FLUOTHANE, ICI Pharmaceuticals) vapour followed by exsanguination. The animals were given a gross post mortem examination. - Statistics:
- No data
Results and discussion
- Preliminary study:
- The main study was preceded by a preliminary study (speculative oral study] in which a dose level of 2000mg/kg was tested on a small group of animals. Based on information from this study the dose-level for the main study was selected as 2000mg/kg.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no signs of toxicity and none of the animals died.
- Clinical signs:
- other: The faeces, urine, coat and tail of the animals were stained red by the test sample but this is considered not to be of toxicological significance.
- Gross pathology:
- There were no macroscopic abnormalities detected in any of the animals at the post mortem examination.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose of substance HI12339 was greater than 2000mg/kg to both male and female rats.
- Executive summary:
The report was conducted in accordance with the following Good Laboratory Practice (GLP), no test guidance is referenced within the study report although this is deemed equivalent to OECD Guideline 401.
A group of five male and five female rats received a single oral dose of 2000mg/kg substance H112339. The animals were assessed daily up to day 15 for any signs of toxicity and their bodyweights were recorded at intervals.
No signs of systemic toxicity were observed and none of the animals died.
The acute oral median lethal dose of substance HL12339 was greater than 2000mg/kg to both male and female rats.
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