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EC number: 939-992-3
CAS number: -
There are two studies
available for this endpoint for source chemical, CAS 1325 -54 -8. This
substance is considered as structural analogue to CAS 1195028 -55 -7:
has the same organic part but contains only Na+ cations instead of a
mixture of Na+ and Li+. The read-across study supplied supports the
feasibility of the approach.
Both studies were
performed according to Guideline OECD 406 and were GLP compliant. In the
study of Hagemann (1993) the test material used for testing was "roh
trocken" meaning "crude". The sample tested had a content of 91% of
active substance and inside the report it is defined that purity is 27%.
In a more recent study done by Arcelin (1995) the test material is
described as "gereignit" meaning "purified". The composition of the
tested sample is not known.When purified, it is assumed that the purity
of the sample will be higher than the one used in Hagemann (1993) test.
Under the test conditions of Arcelin (1995), EC 215-397-8 at
concentrations of 15% in bi-distilled water is considered to be a
non-sensitizer. Similar results were obtained with testing conditions of
Hagemann (1993) at concentration 20% in vaseline. There is also one
study done with humans in 1972, Shelansky (1972). This is a human
repeated insult patch test and the tested material gave a negative
result on sensitisation when tested at 4% in 200 individuals covering a
wide range of ages. The human patch test does not give any information
concerning classification. The source substance with CAS 1325 -54 -8 has
a higher purity than the test item used in the Hagemann’s study (27%)
and therefore closer to the test substance used in Arcelin’s study. It
can be concluded that the source substance 1325-54 -8 is not skin
sensitizer. An increase of toxic effects due to the presence of Li+ in
the target chemical CAS No 1195028-55-7 is not expected and read across
to the source chemical Direct Orange 39 Na salt is regarded as feasible.
Justification for selection of skin sensitisation endpoint:
Read-across study considered relevant and reliable.
This endpoint is not an information requirement of Annex IX of REACH
Based on the above stated assessments of the skin sensitisation
potential, the substance is classified as non-sensitising according to
Directive 67/548/EEC and according to CLP (Regulation (EC) No 1272/2008
of the European Parliament and of the Council) as implementation of
UN-GHS in the EU.
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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