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EC number: 225-590-9
CAS number: 4948-15-6
The dermal route is typically covered by oral route information in the
absence of data for this administration route. Since no data on
penetration through skin are available, the dermal absorption property
is evaluated based on physico-chemical parameters. The test substance is
practically insoluble in both water and organic solvents with a rather
large molecular weight (Mw= 598). As a result, absorption via the dermal
route is expected to be below 10%. This is taken into account by
modifying the NOAEL with a factor of 10 (ECHA GD chapter R7c).
Identification of relevant dose descriptor
The test substance belongs to a category of organic pigments that
all share a similar chemical structure (see CSR for category
justification). Within this category, several substances were selected
for testing in repeated dose toxicity studies. None of these studies
revealed adverse effects for any tested substance up to the highest
doses tested. Based on these results, together with toxicokinetic
considerations, it was concluded that the members of this category are
not taken up by the body after oral ingestion and are therefore not
systemically available. Nevertheless, as worst case assessment, DNELs
for systemic effects were established. In the available 28-day and
90-day repeated dose studies performed with several category members,
NOAELs ranging from 1000 mg/kg to 5000 mg/kg body weight were
established (highest doses tested). Since the data obtained with
individual category members were shared within the category, it was
chosen to select the lowest NOAEL of 1000 mg/kg obtained after 28-day
administration as common dose descriptor for every substance within the
group. This value was therefore used as starting point to derive the
The dose descriptor chosen is the same as for workers (see above).
The NOAEL of 1000 mg/kg was used as starting point to derive the DNELs.
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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