Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 290-904-3 | CAS number: 90268-98-7
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Expert Statement
- Type of information:
- other: Expert Statement
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Expert Statement, no study available
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Details on test animals or test system and environmental conditions:
- not applicable
- Positive control reference chemical:
- not applicable
- Details on study design:
- not applicable
- Details on dosing and sampling:
- not applicable
- Statistics:
- not applicable
- Details on absorption:
- Bioavailability via oral route is strongly linked to physico-chemical properties of the substance. Generally, oral absorption is favoured for molecular weights below 500 g/mol. Furthermore, a high water solubility of more than 100 mg/L enables the substance to readily dissolve in the gastrointestinal fluids, allowing direct uptake into the systemic circulation through aqueous pores or via carriage of the molecules across membranes with the bulk passage of water. The test item is an UVCB substance and does not have a defined molecular structure but consists of large molecules well above 500 g/mol. The water solubility of 2.81 mg/L does not favour absorption. Taken together, the physiochemical properties indicate that the substance is not bioavailable following the oral route. This assumption is confirmed by the results of acute and repeated dose oral toxicity studies (OECD 423, OECD 422 DRF and OECD 422 main study). No substance related effects or mortality were observed.
The volatility indicates whether a substance may be available for inhalation as a vapour. Volatility decreases with increased molecular weight. In particular due to the high molecular weight absorption of the test item via inhalation route is not expected to occur.
Dermal uptake is favoured for substances with a molecular weight <100 g/mol. The molecular weight of the substances is thus too large. In addition, the substances must be sufficiently soluble in water to partition from the stratum corneum into the epidermis. Absorption is anticipated to be low to moderate if water solubility is between 1 and 100 mg/L. The test item has a water solubility of 2.81 mg/L, therefore not supporting dermal absorption. - Details on distribution in tissues:
- In general, the smaller the molecule, the wider the distribution. Based on its molecular weight distribution (no fractions below 3460 Da) and the hydrophilicity (log Pow <-0.7) it is assumed, that if absorbed, the test substance is not widely distributed and that distribution is only within the aqueous compartment of the organism. Furthermore, an accumulation within adipose tissue can be excluded.
- Details on excretion:
- Leuco Sulfur Yellow 22 is most likely excreted via faeces due to its high molecular weight and its poor water solubility.
- Details on metabolites:
- The test substance is not expected to be bioavailable following oral, inhalative or dermal exposure. In case minor amounts become systemically bioavailable, a prediction of the metabolism is not possible as the test item is a UVCB substance with unknown structure. Based on the results of the Ames test, HPRT test and Chromosome Aberration test it can be assumed that the test substance is not enzymatically activated (toxified) during the metabolism as the metabolic activated test substance showed no higher toxicity compared to the test substance without metabolic activation. Furthermore, available data indicate that the test substance is not susceptible to hydrolysis. Therefore an unaltered passage of the parent substance through the stomach can be presumed.
- Conclusions:
- Due to the high molecular weight and low water solubility of the test substance no absorption is expected by the oral, inhalative or dermal route. The substance is excreted in faeces.
- Executive summary:
Based on physicochemical characteristics (very high molecular weight, low water solubility) no absorption by the oral, inhalative or dermal route as well as no distribution of the test substance is expected. This assumption is further supported by the results of the acute oral toxicity study, revealing no substance related effects. In case minor amounts become systemically bioavailable, enzymatic activation (toxification) yielding in cytotoxic metabolites is not expected to occur as metabolic activation did not increase the toxicity of the test substance in an Ames test, HPRT test and Chromosome Aberration test. Due to the size of the molecule and the poor water solubility excretion via feces is assumed.
Reference
Description of key information
Based on physicochemical characteristics (very high molecular weight, low water solubility) no absorption by the oral, inhalative or dermal route of the test substance is expected. This assumption is further supported by the results of the acute oral toxicity study, revealing no substance related effects and no coloration of urine and internal organs up to the highest tested concentrations. In case minor amounts become systemically bioavailable, distribution within the aqueous compartment, but no wide distribution is assumed. Enzymatic activation (toxification) yielding in cytotoxic metabolites is not expected to occur as metabolic activation did not increase the toxicity of the test substance in an Ames test, HPRT test and Chromosome Aberration test. Due to the size of the molecule and the poor water solubility excretion via feces is assumed.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Absorption
Bioavailability via oral route is strongly linked to physico-chemical properties of the substance. Generally, oral absorption is favoured for molecular weights below 500 g/mol. Furthermore, a high water solubility of more than 100 mg/L enables the substance to readily dissolve in the gastrointestinal fluids, allowing direct uptake into the systemic circulation through aqueous pores or via carriage of the molecules across membranes with the bulk passage of water. The test item is an UVCB substance and does not have a defined molecular structure but consists of large molecules well above 500 g/mol. The water solubility of 2.81 mg/L does not favour absorption. Taken together, the physiochemical properties indicate that the test substance is not bioavailable following the oral route. This assumption is confirmed by the results of acute and repeated dose oral toxicity studies (OECD 423, OECD 422 DRF and OECD 422 main study). No substance related effects or mortality were observed.
The volatility indicates whether a substance may be available for inhalation as a vapour. Volatility decreases with increased molecular weight. In particular due to the high molecular weight absorption of the test item via inhalation route is not expected to occur.
Dermal uptake is favoured for substances with a molecular weight < 100 g/mol. The molecular weight of the substances is thus too large. In addition, the substances must be sufficiently soluble in water to partition from the stratum corneum into the epidermis. Absorption is anticipated to be low to moderate if water solubility is between 1 and 100 mg/L. The test substance has a water solubility of 2.81 mg/L, therefore not supporting dermal absorption.
Distribution:
In general, the smaller the molecule, the wider the distribution. Based on its molecular weight distribution (no fractions below 3460 Da) and the hydrophilicity (log Pow <-0.7) it is assumed, that if absorbed, the test substance is not widely distributed and that distribution is only within the aqueous compartment of the organism. Furthermore, an accumulation within adipose tissue can be excluded.
Metabolism:
The test substance is not expected to be bioavailable following oral, inhalative or dermal exposure. In case minor amounts become systemically bioavailable, a prediction of the metabolism is not possible as the test item is a UVCB substance with unknown structure. Based on the results of the Ames test, HPRT test and Chromosome Aberration test it can be assumed that the test substance is not enzymatically activated (toxified) during the metabolism as the metabolic activated test substance showed no higher toxicity compared to the test substance without metabolic activation. Furthermore, available data indicate that the test substance is not susceptible to hydrolysis. Therefore an unaltered passage of the parent substance through the stomach can be presumed.
Excretion:
According to the physicochemical properties of the test substance, molecular weight, hydrophilic characteristics and water solubility, the main route of excretion is expected to be via faeces.
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.