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EC number: 220-562-2
CAS number: 2814-77-9
In the study the test item dissolved in Acetone:olive oil, 4:1 (v/v) was
assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item
concentrations of 5, 10, and 17 % (w/v).
No symptoms of local toxicity at the ears of the animas and no systemic
findings were observed during the study period. Due to the intense red
colour of the test item local irritation reactions such as ear redness
could not be detected.
this study Stimulation Indices (S.I.) of 1.17, 1.29, and 1.26 were
determined with the test item at concentrations of 5, 10, and 17 % (w/v)
in acetone:olive oil, 4:1 (v/v), respectively
The test item C.I.
Pigment Red 4 was found to be a not skin sensitiser in this assay
Value used for CSA: not
The following information is taken into
account for any hazard / risk assessment:
Respiratory tract sensitisation:
Substance is not classified for this
endpoint. The substance is considered not to exert any sensitizing
effects on the respiratory tract; when aerosolized in respirable form,
the substance is considered likely to behave like an inert dust.
Non-human information: This information is
Pigment Red 4 did not show skin sensitising
properties in LLNA study with mice.
It can reasonably be deduced that Pigment Red
3 does not cause respiratory tract sensitization and thus does not have
to be classified according to the criteria laid down in the EU Dangerous
Substances Directive (67/548/EEC) and in the EU Classification Labelling
and Packaging Regulation (1272/2008/EC), because
- Pigment Red 4 did not cause skin
- it is unlikely that Pigment Red 4 can
interact with the immune system due to its extremely low solubility in
water and n-octanol.
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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