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EC number: 410-510-9 | CAS number: 86753-82-4
- 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
- Type of information:
- other: Expert statement
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Objective of study:
- other: Assessment of toxicokinetic behaviour
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Available data on toxicity were evaluated for toxikokinetic behaviour
- GLP compliance:
- no
- Metabolites identified:
- no
Reference
Description of key information
An extensive toxicokinetic assessment is
considered of limited value. Below, an assessment of the anticipated
toxicokinetic behaviour is given. At neutral pH, the sulponated
components will be completely ionised. The physico-chemical properties
make it unlikely that the compound will be absorbed to a hhigh extent
from the gastro-intestinal tract. However,
for some azo-dyes it has been shown that intact particles
may also be taken up by the duodenum, although this is
unlikely because of its high molecular weight and pigment characteristic.
Unlike for other azo-dyes, the azo-bonds of the azo-pigment
components will not, or only to
a very limited extent, be splitted in the gastro-intestinal ttract.
For water-soluble PY12 derivatives (the
sulphonated compound with Na+ as counter ion) it has been
shown that it is not susceptible to gut bacterial metabolism
in vivo. There are two reasons why Hypersol Synergist L 4722 does not show cleavage of the azo-bonds. The first
reason is the very low solubility of the three components of
Hypersol Synergist L 4722. The second reason is the fact
that the components do have chemical structures significantly different from benzidine
and dichlorobenzidine derived azo dyes. The latter is probably even more important than water solubility, since
even when a water-soluble sulphonated analogue of Pigment YYellow 12 was
administered orally to rats, over the next 24
hours only 0.02% of the radioactivity was found in the urine and none in the blood or tissues. The remainder was
recovered in the large intestine, the intestinal contents and faeces. Long-term studies (up to 2 years) with
Pigment Yellow 12 by the US National Cancer Institute revealed absence of carcinogenicity and thus, there was no
indication for formation of dichlorobenzidine from the pigment.
For Pigment Yellow 13, Pigment Yellow 83, and
Pigment Yellow 174, which are also diarylide azo- pigments, neither
formation of dichlorobenzidine in metabolism studies
nor carcinogenic potential was observed . Absence of the dichlorobenzidine in urine was also observed in a
study with Pigment Yellow 13 after oral administration to rats,
rabbits and monkeys.
Although it is difficult to extrapolate the azoreductase
activity from animals to humans, it is generally
assumed that the activity in rats is higher than in humans.
Therefore, the rat is considered a good model for safety
evaluation regarding drug metabolism. The very small fraction of
absorbed Hypersol Synergist L 4722 will probably undergo cytochrome P450-mediated hydroxylation of the
aromatic rings. However, the formed metabolites of Hypersol
Synergist L 4722 are not expected to lead to toxic
effects, since cleavage of the azo-bonds is not anticipated for the same reasons as mentioned above. The metabolites
will show a toxicokinetic behaviour comparable to that of the unchanged Hypersol Synergist L 4722. The formed hydroxy-metabolites will probably be conjugated and excreted via
urine or bile. Distribution of Hypersol Synergist L 4722
into peripheral tissues will be limited, because of the anticipated high plasma protein binding.
Since it is generally accepted that substances with log Po/w
ranging from 0.1 to 6 penetrate the skin easily, it is to be expected that Hypersol L4722 will be absorbed to some
extent through the skin. However, following dermal application under cover, the total dose of Pigment Yellow 12
could be accounted for by the radioactivity at the site of
application and on the patch and pipette tip. Therefore,
it is concluded that the dermal uptake of Hypersol
Synergist L 4722 is negligible.
Taking into account the available physico-chemical data, it
is expected that the systemic exposure to Hypersol Synergist
L 4722 will be very low.
Based on the expected kinetic behaviour in the body, as
described above, Hypersol L4722 will not accumulate in the body after prolonged exposure. This assumption is supported
by the low toxicity observed during the 28-days repeated dose toxicity study.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
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.
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