Registration Dossier
Registration Dossier
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EC number: 211-190-1 | CAS number: 633-03-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
There are available data bof on animals and for humans on different triphenylmethane dyes which showed some sensitizing effects on skin.
There are also in vitro studies performed on similar substances 02, 03 and 06 which resulted all positive and those tests confirm the skin sensitizing potential of this kind of dye.
Based on the above considerations, Basic Green 1 should be considered as contact sensitizers.
Migrated from Short description of key information:
Sensitizing
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Skin sensitization: in vitro studies were conducted according to NCTC2544/IL-18 andTHP-1 activation methods, pre-validation on going, on MG Oxalate and Chloride salts and the two different assays showed that MG salts resulted both positive, confirming moreover the similar biological activity of MG salts. MG salts should be considered as contact sensitizers.
Respiratory sensitization: no data available
Justification for classification or non-classification
Results on in vitro test on human skin identified Malachite Green as a skin sensitizer. This result is supported, according to the application of CLP criteria, by the comparison with similar substances. Nevertheless data available do not allow to define the sub-category 1A or 1B.
According to CLP regulation (EC1272/2008) Malachite Green Acetate is classified as Skin Sens 1, H317 (May cause an allergic skin reaction).
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