Registration Dossier
Registration Dossier
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EC number: 268-684-5 | CAS number: 68133-40-4
Endpoint summary
Administrative data
Description of key information
QSAR prediction on DPRA: positive
in vitro, OECD 442E: negative
in vitro, OECD 442D: negative
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A prediction was carried out by OECD QSAR Toolbox 4 to assess key event 1 of skin sensitisation, i.e. the potential of target substance to covalent binding to skin proteins. Structural alerts on target substance for this endpoint were identified as 1,3,5 -triazine derivatives with Cl atom as functional group. In case of aromatic nucleophilic attack by -NH2 and -SH group of model peptides, i.e. lysine and cysteine, Cl atom acts as leaving group.
A study according to OECD guideline 442D to assess key event 2 of skin sensitisation, i.e. the potential of target substance to induce the release of pro-inflammatory cytokines and induce cyto-protective pathways in keratinocytes, was performed. The test was found to be negative in the ARE-Nrf2 Luciferase Test.
A study according to OECD guideline 442E was conducted to investigate key event 3 of skin sensitisation, i.e. the potential of target substance to activate monocytes and dendritic cells in the human monocytic leukemia cell line THP-1, by quantifying changes in the expression of cell surface markers (CD86 and CD54). Target substance was found to be negative in hCLAT.
Based on a negative Lusens result and a negative H-CLAT result the substance is concluded to be a non skin sensitiser and further investigation is not considered as necessary.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the Guidance on the application of CLP criteria (ECHA, 2017): ''Validated in vitro/in chemico methods exist with the aim to identify a sensitising potential of a chemical. These include OECD TG442C (Peptide/protein binding), TG442D (keratinocyte response) and TG 442E (monocytic/dendritic cell response). The in vitro/in chemico tests are not regarded as stand alone tests and the result from such a test should be used together with other data in an overall WoE assessment. Further, at present there is no agreed strategy on how to use in vitro/in chemico methods for direct estimation of sensitising potency, but data from such tests can be used in a WoE assessment together with other data in order to assess skin sensitisation potency. See also the Guidance on IR&CSA, especially Section R.7.3.4.1.''
A skin sensitiser refers to a substance that will lead to an allergic response following skin contact. There is general agreement regarding the key biological events underlying skin sensitisation. The existing knowledge of the chemical and biological mechanisms associated with skin sensitisation has been summarised in the form of an Adverse Outcome Pathway (AOP), from the molecular initiating event through the intermediate events to the adverse effect namely allergic contact dermatitis in humans or contact hypersensitivity in rodents.
Mechanistically based in chemico and in vitro test methods have been considered scientifically valid for the evaluation of the skin sensitisation hazard of chemicals. However, combinations of non-animal methods (in silico, in chemico, in vitro) within Integrated Approaches to Testing and Assessment (IATA) will be needed to be able to fully substitute for the animal tests currently in use, given the restricted AOP mechanistic coverage of each of the currently available non-animal test methods.
Available data is:
- key event 1: positive
- key event 2: negative
- key event 3: negative
Considering the negative result in H-CLAT and the negative result in LuSens, and expecting that the substance does not have the potential to produce significant sensitisation in humans, the substance is proposed as non sensitizer according to the CLP Regulation (EC) No.1272/2008
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.
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