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EC number: 854-560-3 | CAS number: 1891094-25-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental study started 6th December 2016 and experimental study was completed 21st December 2016. Final report was issued 2nd March 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- EC Number:
- 854-560-3
- Cas Number:
- 1891094-25-9
- Molecular formula:
- C53H38N4Na6O22S5
- IUPAC Name:
- hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl: WI Wistar rats
Source: Charles River Laboratories, Research Models and
Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant
Age of animals at dosing: Young healthy adult rats, 8-9 weeks old
Body weight at treatment: 193 – 212 g
Acclimatization period: 12 or 13 days Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 522/7
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Lignocel 3/4-S Hygienic Animal Bedding” produced by J. Rettenmaier & Söhne GmbH & CO.KG (D-73494 Rosenberg, Germany) was
available to animals during the study. Certified nest building material was also provided for animals (ARBOCEL crinklets natural produced by J. Rettenmaier & Söhne GmbH +Co KG).
A copy of the Certificate of Analysis is retained in the archives at CiToxLAB Hungary Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.0 – 24.4 °C
Relative humidity: 29 – 58 %
Ventilation: 15 – 20 air exchanges/hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test item was administered formulated in distilled water at a concentration of 200mg/mL at a dose volume of 10 mL/kg bw.The test item was administered formulated in distilled water at a concentration of 200mg/mL at a dose volume of 10 mL/kg bw.
Initially, three female animals (Group 1) were treated with 2000 mg/kg bw of the test substance. No mortality was observed, therefore further 3 animals (Group 2) were treated at the dose level of 2000 mg/kg bw. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris. - Doses:
- 1
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- The single-dose oral toxicity of the test substance was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in Crl: WI Wistar rats.
Two groups of three female Crl: WI Wistar rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in distilled water at a concentration of 200mg/mL at a dose volume of 10 mL/kg bw.
Initially, three female animals (Group 1) were treated with 2000 mg/kg bw of the test substance. No mortality was observed, therefore further 3 animals (Group 2) were treated at the dose level of 2000 mg/kg bw. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours afterdosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test substance did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Treatment with the test substance at the dose level of 2000 mg/kg bw caused reddish coloured faeces and urine (6/6) on Days 0-2.
- Other findings:
- Macroscopic findings. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Crl: WI Wistar rats. According the GHS criteria, Dye-2016 can be ranked as "Category 5" or "Unclassified"for acute oral exposure.
- Executive summary:
Introduction
This study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Crl: WI Wistar rats. The method was designed to meet the requirements of the following guidelines:
OECD Guideline for the Testing of Chemicals No. 423 'Acute Oral Toxicity - Acute Toxic Class Method' (adopted 17 December 2001)
Method
Two groups of three fasted females were treated with the test substance at a dose level of 2000 mg active ingredient/kg bodyweight. The test item was administered orally as a solution in distilled water. Clinical signs and bodyweight were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality: There were no deaths.
Clinical Observations: Treatment with the test substance at the dose level of 2000 mg/kg bw caused reddish coloured faeces and urine (6/6) on Days 0-2.
Body weight gains of test substance treated animals during the study showed no indication of a test item-related effect.
Macroscopic Findings There was no evidence of the macroscopic observations at a dose level of
2000 mg/kg bw.
Conclusion
Under the conditions of this study, the acute oral LD50 value of the test item Dye-2016 was found to be above 2000 mg/kg bw in female Crl: WI Wistar rats. According the GHS criteria, Dye-2016 can be ranked as "Category 5" or "Unclassified"for acute oral exposure.
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