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EC number: 297-025-4
CAS number: 93281-13-1
No evidence of bioaccumulative potential.
Direct Black 168 is a dark organic powder.
Direct Black 168 is not toxic/harmful for
short-term exposures and it is not skin irritating; however, it is able
to cause eye irritation.
Direct Black 168 is not a skin sensitizer
agent. No CMR activity has never been reported and has been observed in
specific experiments performed.
No adverse effects were observed during
the experiments run, thus, mechanisms of bioactivation leading to
adverse effects are not expected to occur at moderate dosages.
Specific studies or specific literature
data on toxicokinetics and metabolism are not available, thus
information about the substance has been taken into account, avoiding
Because of the molecular structure and the
hydrophilic of Direct Black 168, dermal absorption is expected to be
negligible. Based on the available information, potential dermal
toxicity is not suspected. Furthermore, the substance gave negative
results in skin sensitisation assay, thus it is considered as not able
to cause an allergic response in susceptible individuals, after exposure
via the skin.
Because of the physical state and the
characteristic particle size distribution, inhalation is not an
appropriate route of exposure.
During the oral toxicity experiments, both
acute and subacute, the treatment did not produce severe changes
detected in health condition. The main finding, attributable to the test
item treatment, was dark stool in the bedding material recorded in the
groups tested at the medium and high dose levels; dark colour of the
faeces was due to the elimination of test item or its metabolite by the
Clinical signs of systemic toxicity
related to the test item and significantly impacting the tested animals
were not detected at moderate dose levels. Haematological evaluation did
not reveal adverse test item related changes, as well as changes in the
serum thyroid hormone were not detected.
Minimal centrilobular vacuolation in the
hepatocytes – sign of hepatic lipidosis – was found during the repeated
dose toxicity test (lasting 42 – 56 days). Hepatic lipidosis is
considered as a slight reversible liver injury in connection with a
disturbance of energy metabolism of affected hepatocytes.
The finding of coloured faeces after
single dose, as well as after repeated administrations, and the almost
complete absence of any other effects let to expect that the substance
can be significantly excreted.
The presence of coloured stool and
coloured content of stomach and intestines let to expect that the
scaffold was not significantly modified by transformation; colour proves
that the conjugation is not completely interrupted. However, the
extension of the elimination rate of the substance as such cannot be
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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