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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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
In a repeated dose toxicity study with reproduction/developmental toxicity screening according to OECD guideline 422 and GLP Leuco Sulfur Black 1 was administered by gavage to groups of 10 rats per sex and dose at 0, 100, 300 and 1000 mg/kg bw/d. Male rats were treated for 29 days, female rats for 14 days prior to pairing, though the pairing and gestation periods until the F1 generation had reached day 4 post partum. The test item was administered in water as vehicle at a dose volume of 10 mL/kg bw/d. Control animals were doses with the vehicle alone.
Observation and examinations consisted of mortality, clinical signs, detailed clinical observations, food consumption, body weight, functional observation battery, clinical biochemistry, haematology, urinalysis, macroscopical examination at necropsy, organ weights and histopathological examination of organs. Reproductive parameters examined were examination of reproductive organs with special emphasis on the stages of spermatogenesis and histopathology of interstitial cell structure, mating performance and fertility, duration of gestation, implantation sites, pre- and post-implantation loss, corpora lutea count. Parameters relevant for developmental toxicity consisted of litter size, number of live and dead pups, sex ratio, pup weight at day 4 post partum, macroscopical examination of pups at termination.
The only effect seen was a dark discolouration of faeces in all high dose animals starting on day 3 of the study and lasting until termination. Based on this finding a NOAEL of 1000 mg/kg bw/d was derived for general toxicity as well as for reproductive and developmental toxicity.
The discolouration of faeces was the only effect observed in this study and also in the acute oral toxicity study. Organs or urine were not discoloured and signs of substance deposits were not found in histopathological analysis of the organs. This indicates that Leuco Sulfur Black 1 is directly excreted and that absorption in the gastrointestinal tract does not occur following oral administration.
The mean molecular weight and number-average molecular weight (Mn) of Leuco Sulfur Black 1 is > 8000 Da. It is very poorly or even not soluble in common polar and non-polar solvents such as water (solubility of 62.4 mg/L), DMSO, methanol, DMF, THF, chloroform and not soluble in acid likes sulfuric acid and trifluoroacetic acid. The vapour pressure of the pure substance, calculated from the boiling point of > 400 °C, is 1.8 x 10E-5 hPa at 25 °C. These substance properties supported by the results of oral toxicity studies demonstrate that the absorption of Leuco Sulfur Black 1 via the oral, dermal or inhalation route and, consequently, systemic bioavailability is negligible.
Based on the substance properties and the fact that no toxicity was seen in any of the tests it is concluded that exposure to Leuco Sulfur Black 1 does not raise any health concern. In line with Regulation (EC) No 1907/2006 Annex XI and taking into account the REACH paradigm that new tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted, further animals studies to examine the reproductive and developmental toxicity of Leuco Sulfur Black 1 are not necessary and should not be performed.
Short description of key information:
Leuco Sulfur Black 1 did not cause any toxic effects in the repeated dose toxicity study with reproduction/developmental toxicity screening in rats (OECD 422). The limit dose of 1000 mg/kg bw/d was derived as NOAEL for general parental toxicity and reproductive/developmental toxicity.
Effects on developmental toxicity
Description of key information
Leuco Sulfur Black 1 did not cause any toxic effects in the repeated dose toxicity study with reproduction/developmental toxicity screening in rats (OECD 422). The limit dose of 1000 mg/kg bw/d was derived as NOAEL for general parental toxicity and reproductive/developmental toxicity.
Additional information
see "effects on fertility"
Justification for classification or non-classification
Based on the available data Leuco Sulfur Black 1 is not subject to classification and labelling according to Directive 67/548/EECand Regulation 1272/2008/EC.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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