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EC number: 310-132-3 | CAS number: 61902-31-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 53235
- 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:
- 05 September - 29 September, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001 December 17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation (EC) No 440/2008
- Version / remarks:
- 2008 May 30
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation (EC) No. 1272/2008
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Leuco polysulfided 4-[(2,4-dinitrophenyl)amino]phenol
- EC Number:
- 310-132-3
- EC Name:
- Leuco polysulfided 4-[(2,4-dinitrophenyl)amino]phenol
- Cas Number:
- 61902-31-6
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction product of 4-[(2,4-dinitrophenyl)amino]phenol with sodium polysulfide, leuco derivatives
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test item: Leuco Sulfur Blue 11
Appearance: dark black powder
CAS No. 61902-31-6
EC No. 310-132-3
Storage: room temperature
Constituent 1
- Specific details on test material used for the study:
- Expiration date: 29.04.2020
Correction factor: 1.08
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI, SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult rat, 8 weeks old in first and second step
- Weight at study initiation: first step 185 - 189 g; second step 186 - 192 g
- Fasting period before study: the day before administration
- Housing: Group caging (3 animals/cage) in Type II cages
- Diet: ssniff Spezialdiäten GmbH, 59494 Soest, Germany, ad libitum
- Water: tap water from municipal supply, as for human consumption from bottle ad libitum.
- Acclimation period: 5 days in first step and 6 days in second step
- Animal health: Only healthy animals were used for the study. Health status was certified by the study director.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes: above 10 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12/12, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua purificata Ph.Hg. VIII, Parma Produkt Kft.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: treatment volume of 10 mL/kg bw
- Batch no.: 1606-5508
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. - Doses:
- 2000 mg dyestuff/kg bw (corresponding to 2160 mg test item/kg bw)
- No. of animals per sex per dose:
- 3 animals/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter. The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15.
- Necropsy of survivors performed: yes. At the end of the observation period all survivor rats were sacrificed under isofluran anaesthesia (Batch No B49G15A. Piramal Healthcare UK Ltd). After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size.
- Other examinations performed: Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- The method used is not intended to allow statistical evaluation and the calculation of a precise LD50 value.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No death occurred at 2000 mg/kg bw after a single oral dose. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
- Clinical signs:
- other: In group 1 and 2 treated with 2000 mg/kg bw, no treatment related symptoms were observed throughout the 14-day post-treatment period.
- Gross pathology:
- All animals treated with 2000 mg/kg bw survived until the scheduled necropsy on Day 15. Moderate hydrometra was found in one animal of group 1. Hydrometra is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
Any other information on results incl. tables
Table 2: GHS classification according to the results
Dose |
Mortality |
LD50 |
GHS |
2000 |
0/6 |
between 5000 and 2000 |
5 |
Table 3: Summary of Lethality. Post-treatment observation period (14 days)
Groups |
Treatment |
Lethality |
|
Test Item |
Dose |
Females |
|
1 |
Leuco Sulfur Blue 11 |
2000 |
0/3 |
2 |
Leuco Sulfur Blue 11 |
2000 |
0/3 |
Table 4: Summary of Clinical Symptoms
FEMALES
Groups |
Treatment |
Symptoms |
Incidence |
|
Test Item |
Dose |
|||
1 |
Leuco Sulfur Blue 11 |
2000 |
Normal |
57/57 |
2 |
Leuco Sulfur Blue 11 |
2000 |
Normal |
57/57 |
Remark: Incidence = Number of symptoms/Summarized number of observations inside the group
Summarized number of observations inside the group =
(number of observations of first animal) + (number of observations of second animal) +(number of observations of third animal
Table 5: Summary of Body Weights (g)
FEMALES |
|
Day 0 |
Day 7 |
Day 15 |
|
|
|
|
|
Group 1: Leuco Sulfur Blue 11 |
||||
2000 mg/kg bw, Step 1 |
|
|
|
|
|
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
186.7 |
231.7 |
249.7 |
SD: |
|
2.08 |
7.09 |
13.32 |
|
|
|
|
|
FEMALES |
|
Day 0 |
Day 7 |
Day 15 |
|
|
|
|
|
Group 2: Leuco Sulfur Blue 11 |
||||
2000 mg/kg bw, Step 2 |
|
|
|
|
|
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
188.3 |
233.0 |
252.7 |
SD: |
|
3.21 |
14.80 |
17.95 |
|
|
|
|
|
Table 6: Summary of Body Weight Gains (g)
FEMALES |
|
Day 0-7 |
Day 7-15 |
Day 0-15 |
|
|
|
|
|
Group 1: Leuco Sulfur Blue 11 |
||||
2000 mg/kg bw, Step 1 |
||||
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
45.0 |
18.0 |
63.0 |
SD: |
|
7.55 |
6.24 |
13.53 |
|
|
|
|
|
FEMALES |
|
Day 0-7 |
Day 7-15 |
Day 0-15 |
|
|
|
|
|
Group 2: Leuco Sulfur Blue 11 |
||||
2000 mg/kg bw, Step 2 |
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
44.7 |
19.7 |
64.3 |
SD: |
|
11.72 |
3.51 |
14.98 |
|
|
|
|
|
Table 7: Summarized Gross Pathology Findings
Observations (Females) Leuco Sulfur Blue 11 (2000mg/kg bw)
Hydrometria 1/6
Normal 5/6
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study (acute toxicity class method, ATC) according to OECD guideline 423, a LD50 of above 2000 mg dyestuff/kg bw, corresponding to 2160 mg test item/kg bw, was determined.
- Executive summary:
In an acute oral toxicity study according to OECD 423, the LD50 of the test item after single oral gavage was determined. The acute toxic class method (ATC) was carried out involving a stepwise procedure starting at 2000 mg dyestuff/kg bw, corresponding to 2160 mg test item/kg bw, in three female Wistar rats. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, according to the stopping criteria of Annex 2d of OECD Guideline 423.
No lethality was noted at a single oral dose of 2000 mg dyestuff/kg bw. In the first and second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal. The body weight development was undisturbed in all animals. Gross pathologically investigations of all organs of the treated animals showed no treatment related changes.
The test item was ranked into classes of Globally Harmonized Classification System (GHS) as described in the OECD Guideline No. 423. However, the method used is not intended to allow the calculation of a precise LD50 value. Therefore a LD50 of above 2000 mg dyestuff/kg bw, corresponnding to 2160 mg test item/kg bw, was determined.
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