Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Read-across from experimental results for the same organic structure . This substance has an identical structure of CAS 1195028-55-7 in respect of the anionic components, but containing Na cations instead of a mixture of Na+ and Li+.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reading:
other:
Remarks on result:
no indication of skin sensitisation
Remarks:
The read-across study supplied supports the feasibility of the approach: see report in the summary endpoint.
Interpretation of results:
GHS criteria not met
Conclusions:
The read-across study supplied supports the feasibility of the approach: see report in the summary endpoint.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

This endpoint is not an information requirement of Annex IX of REACH Regulation.

Justification for classification or non-classification

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.