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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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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:
- Identification: Leuco Sulfur Black 1
CAS No.: 66241-11-0
Description: Thixothrophic, black, wet paste
Batch No.: ESA0007595
Composition: Leuco Sulfur Black 1: 52.75 % (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
Stability of the test item Stable under storage conditions
Stability in solvent: > 4 h in water
Storage: At room temperature (range 20 ± 5 °C), light protected
Expiration Date: July 11, 2011
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:single caging
- Diet (e.g. ad libitum): pelleted standard diet (Harlan Laboratories GmbH, 33178 Borchen), ad libidum
- Water (e.g. ad libitum): tap water, (Gemeindewerke, 64380 Rossdorf), ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness will be used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): artificial light 6:00 a.m. - 6:00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, and 25%
- No. of animals per dose:
- 4
- Details on study design:
- To determine the highest non-irritant test concentration, a pre-test was performed in two animals. Two mice were treated with concentrations of 10 and 25% each on three consecutive days.
In the pre-test clinical signs were recorded within 1 hour and 24 ± 5 hours after each application as well as on day 7. At the tested concentrations theanimals did not show any signs of irritation or systemic toxicity.
The test item in the main study was assayed at 5, 10 and 25%. The top dose is the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation. No severe irritant effects were tolerated choosing the test concentrations. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- Experiment performend in January 2009, 5, 10, and 25% alpha-Hexylcinnamaldehyde yielded a S.I. of 1.49, 4.17, and 4.90, respectively. The EC3 value calculated was 7.8%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1.4 (at 5 %), 1.1 (at 10 %), 1.6 (at 25 %)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table below
Any other information on results incl. tables
Test item concentration % (w/w) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
25 |
--- |
--- |
--- |
--- |
--- |
BG II |
39 |
--- |
--- |
--- |
--- |
0 |
1 |
2735 |
2703 |
8 |
337.9 |
1.00 |
5 |
2 |
3869 |
3837 |
8 |
479.6 |
1.42 |
10 |
3 |
3067 |
3035 |
8 |
379.4 |
1.12 |
25 |
4 |
4386 |
4354 |
8 |
544.3 |
1.61 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate 1=Control Group 2-4=Test Group S.I.=Stimulation Index
a)=The mean value was taken from the figures BG I and BG II b)=Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value can not be calculated, since all S.I.´s are below 3.
Viability / Mortality
No deaths occurred during the study period.
Clinical Signs
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Body Weights
The body weight of the animals, recordedprior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Leuco Sulfur Black 1 was not a skin sensitiser under the described conditions.
- Executive summary:
The present study (Vogel 2009) analyses the sensitising potential of Leuco Sulfur Black 1
Three groups each of four female mice were treated daily with the test item at concentrations of 5, 10 and 25% (w/w) in dimethylformamide by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (dimethylformamide) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3H-methyl thymidine measured in ab-scintillation counter.
All treated animals survived the scheduled study period and no signs of toxicity were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.42, 1.12 and 1.61 were determined with the test item at concentrations of 5, 10 and 25% in dimethylformamide.
The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than 3.
The test item Leuco Sulfur Black 1 was not a skin sensitiser under the described conditions.
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