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EC number: 266-273-5 | CAS number: 66241-11-0 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 53185.
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-01-20 till 2009-02-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Phenol, 2,4-dinitro-, sulfurized, leuco derivatives
- EC Number:
- 266-273-5
- EC Name:
- Phenol, 2,4-dinitro-, sulfurized, leuco derivatives
- Cas Number:
- 66241-11-0
- Molecular formula:
- Molecular formula is not available.
- IUPAC Name:
- Reaction products of 2,4-dinitrophenol with polysulfide, leuco derivatives, sodium salt
- Details on test material:
- - Name of test material : Leuco Sulfur Black 1
- Physical state: thixotrophic, black, wet paste
- Composition: Leuco Sulfur Black 1:52.75 % (w/w) (calculated by amount of by-compounds)
2,4-Dinitrochlorobenzene: < 20 ppm
2,4-Dinitrophenole: < 20 ppm
Sulfate: 970 ppm
Chloride: 750 ppm
Sodium: 1.3 % (w/w)
Water: 45.75 % (w/w) by Karl-Fischer titration
- Lot/batch No.: ESA0007595
- Expiration date of the lot/batch: 2011-07-11
- Stability under test conditions: Stable under storage conditions.
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., Füllinsdorf / Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: 175.0 g - 197.7 g
- Fasting period before study: fasted for approximately 15 to16 hours (access to water was permitted)
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libidum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum
- Acclimation period: 2009-01-20 to 2009-01-26 (females, 2000 mg/kg), 2009-01-22 to 2009-01-28 (females, 2000 mg/kg)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.439 g substance/mL vehicle
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: found to be a suitable vehicle
- Purity: purified water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): prior to dosing
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no justification (no data available) - Doses:
- 2319 mg active ingredient /kg bw equals 4396 mg test item / kg bw (Lueco Sulfur Black 1: 52.75% w/w)
- No. of animals per sex per dose:
- 3 females at 2319 mg/kg bw
3 females at 2319 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Viability / Mortality: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15.
Body Weights: On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1, depending on the occurrence of clinical signs of toxicity. Once daily during days 2-15. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 319 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: For the first group of animals treated at 2319 mg/kg, no clinical signs were observed in any of the animals on test 1. On test day 2, all three females were noted with black-stained feces and the cage of the animals was changed to facilitate further asses
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]
Dose (mg/kg bw) |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity (#/total) |
2319 |
0/3 |
n.a. |
0/3 |
2319 |
0/3 |
n.a. |
0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose LD50 (female rat)of Leuco Sulfur Black 1 after single oral administration to female rats, observed over a period of 14 days is greater than 2000 mg/kg body weight
- Executive summary:
The acute toxicity of Leuco Sulfur Black 1 by oral application was investigated according to the OECD Guideline 423 under GLP.
Two groups, each of three female HanRcc:WIST (SPF) rats, were treated by oral gavage administration at a dosage of 2319 mg active ingredient / kg body weight (corresponding to 4396 mg test item / kg body weight). The test item was formulated in purified water according to the content of the active ingredient at a concentration of 0.439 g/mL and administered at a dosing volume of 10 mL/kg.
No deaths occurred during the study. Except for black stained feces from test day 2 up to test day 5 at the latest, no clinical signs were noted in all animals during the observation time. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. LD50 was greater than 2319 mg/kg bw.
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