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EC number: 940-448-2 | CAS number: -
- 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:
- 2013-10-29 to 2013-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD/EU guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- tris(9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-9H-xanthen-9-ylium) 6-[(3-sulfonatonaphthalen-2-yl)methyl]-3-[(6-sulfonatonaphthalen-2-yl)methyl]naphthalene-2-sulfonate
- EC Number:
- 940-448-2
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- tris(9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-9H-xanthen-9-ylium) 6-[(3-sulfonatonaphthalen-2-yl)methyl]-3-[(6-sulfonatonaphthalen-2-yl)methyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, 11 weeks old in group 1, 2 and 3 and 12 weeks old in group 4 and 5
- Weight at study initiation: 190-220 g
- Fasting period before study: yes
- Housing: 3 animals/sex/cage
- Diet: ssniff® SM R/M-Z+H complete diet ad libitum
- Water: tap water ad libitum
- Acclimation period: 26 to 33 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % Methylcellulose solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200, 30 and 5 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Lot/batch no.: N83746634
CLASS METHOD
- Rationale for the selection of the starting dose: Starting dose was selected on the basis of the available information about the test item. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose on three female rats. - Doses:
- First step: 2000 mg/kg bw
Second step: 300 mg/kg bw
Third step: 50 mg/kg bw - No. of animals per sex per dose:
- 3 per treatment or 6 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed individually after dosing once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, after the treatment and once each day for 14 days thereafter.
- Frequency of weighing: The body weight were recorded on day 0 (shortly before the treatment), on day 7, and on day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 0/6 animals died at 50 mg/kg bw.
- Mortality:
- Two rats dosed at 2000 mg/kg bw DOCU Red 116 died on Day 1. Two of six animals treated with 300 mg/kg bw dose of test item died during the study. One animal of group 3 died on Day 3 and one animal of group 3 died on Day 2. All deaths seemed to be consequences of systemic toxic effect of the test item.
No death occurred at 50 mg/kg single oral dose of the test item. All rats in step 4 and step 5 survived until the end of the 14-day observation period. - Clinical signs:
- other: Please refer to "Other findings"
- Gross pathology:
- Two rats treated with 2000 mg/kg bw dose of the test item spontaneously died during the study. One animal treated with the same dose survived until the scheduled necropsy on Day 15. An internal necropsy finding as autolysis was observed in two animals. It is normal physiological process after death. Besides, internal necropsy finding as pale kidneys was observed in one animal of group 1. This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Most likely the observation is a congenital anomaly. Moderate hydrometra was observed in one female of the group 1 is physiological finding and connected to the oestrus cycle of the animal.
Two rats treated with 300 mg/kg bw dose of the test item spontaneously died during the study and four animals treated with same dose survived until the scheduled necropsy on Day 15. An internal necropsy finding as autolysis was observed in two animals of group 3. It is normal physiological process after death. Besides, internal necropsy finding as pale kidneys was observed in one animal of group 3 and in one animal of group 2. This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Most likely the observation is a congenital anomaly. Moderate hydrometra was observed in two females of the group 2 and in one animal of group 3 is physiological finding and connected to the oestrus cycle of the animal.
All animals treated with 50 mg/kg bw dose of test item survived until the scheduled necropsy on Day 15. No pathological changes related to the effect of the test item were found during the macroscopic examination of animals. - Other findings:
- In group 1, treated with 2000 mg/kg bw dose, clinical signs of reaction comprised of decreased activity (14 cases of 29 observations), abnormal gait (13/29), crouching (13/29), red coloured faces (15/29) and piloerection (15/29). Decreased activity, abnormal gait, crouching, red coloured faces and piloerection were observed in all animals. These symptoms were detected between treatment day and Day 6. All animals were free of symptoms on the treatment day 30 min. and 1 hour after the treatment, as well as the survivor animal was free of symptoms between Day 7 and Day 14.
In group 2, treated with 300 mg/kg bw dose, clinical signs of reaction comprised of blood around the nose (1 case of 57 observations), red coloured faces (24/57) and piloerection (5/57). Red coloured faces were observed in all animals. Blood around the nose and piloerection were recorded in one animal. These symptoms were detected between treatment day and Day 5. All animals were free of symptoms on the treatment day 30 min. and 1 hour after the treatment, as well as between Day 6 and Day 14.
In group 3, treated with 300 mg/kg bw dose, clinical signs of reaction comprised of decreased activity (14 cases of 32 observations), abnormal gait (11/32), crouching (12/32), red coloured faces (14/32) and piloerection (12/32). Decreased activity, abnormal gait, crouching, red coloured faces and piloerection were observed in all animals. These symptoms were detected between treatment day and Day 5. All animals were free of symptoms on the treatment day 30 min. and 1 hour after the treatment, as well as the survivor animal was free of symptoms on the treatment day 2 hours after the treatment and between Day 6 and Day 14.
In group 4, treated with 50 mg/kg bw dose, clinical signs of reaction comprised of red coloured faces (12 case of 57 observations) and piloerection (1/57). Red coloured faces were observed in all animals. Piloerection were recorded in one animal. These symptoms were detected between treatment day and Day 2. All animals were free of symptoms on the treatment day 30 min., 1 and 2 hours after the treatment, as well as between Day 3 and Day 14.
In group 5, treated with 50 mg/kg bw dose, clinical signs of reaction comprised of red coloured faces (12 cases of 57 observations). This symptom was observed in all animals on the treatment day 3 and 4 hours after the treatment and between Day 1 and Day 2.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item induced mortality following a single oral administration to female rats at a dose of 2000 and 300 mg/kg bw and did not induced mortality at a dose of 50 mg/kg bw. The LD50 was determined to be between 50 and 300 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test item was assessed in an acute oral toxicity study (acute toxic class method) using Wistar rats according to OECD TG 423 (17 December 2001) and EU guideline B.1 tris (30 May 2008). Starting dose was selected on the basis of the available information about the test item.
Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out in animals died on Day 1, Day 2 and Day 3, as well as 15th day after the treatment in survivor animals.
Two of three animals treated with 2000 mg/kg bw DOCU Red 116 died on Day 1. Two of six animals treated with 300 mg/kg bw dose died on Day 2 and on Day 3, respectively. No lethality was noted at single oral dose of 50 mg/kg bw.
In the first step, CNS symptoms (decreased activity, crouching), disturbances of coordination (abnormal gait), disturbance of the autonomic functions (piloerection) and red coloured faces were observed in animals between the treatment day and Day 6 post-dose. In the second step, blood around the nose, disturbance of the autonomic functions (piloerection) and red coloured faces were observed in animals between the treatment day and Day 5 post-dose. In the third step, CNS symptoms (decreased activity, crouching), disturbances of coordination (abnormal gait), disturbance of the autonomic functions (piloerection) and red coloured faces were observed in animals between the treatment day and Day 5 post-dose. In the fourth step, disturbance of the autonomic functions (piloerection) and red coloured faces were observed in animals between the treatment day and Day 2 post-dose. In the fifth step, red coloured faces were observed in animals between the treatment day and Day 2 post-dose.
The body weight development was undisturbed in all survival animals.
Altogether 4 animals died, and 11 animals were sacrificed as scheduled during the study.
All organs of the animals proved to be free of treatment related gross pathological changes.
The test item induced mortality following a single oral administration to female rats at a dose of 2000 and 300 mg/kg bw and did not induced mortality at a dose of 50 mg/kg bw.
The clinical symptoms observed were connected with systemic toxic effect of the test item, except red coloured faces, which was connected with the physical property of test item.
No test item related effects on body weights and body weight gains were observable during the study. Autopsy revealed no treatment related pathological changes.
The method used is not intended for the precise calculation of a precise LD50 value.
The test item was ranked into acute toxicity, oral, category 3 according to the current EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008:
Dose (mg/kg bw)
Mortality (dead/treated)
LD 50 (mg/kg bw)
CLP category
50
0/6
between 50 and 300
3
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