Registration Dossier
Registration Dossier
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EC number: 292-562-0 | CAS number: 90640-43-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, an in vivo skin sensitisation study does not need to be conducted if the available information indicates that the substance should be classified for skin corrosivity.
Profiling in QSAR Toolbox (v.3.0) indicate that N-C12,14 alkyl-1,3-diaminopropane (C12-14-diamine) is not expected to bind to protein, and QSARs for sensitisation indicate a moderate concern.
Furthermore, its use is limited to industrial and professional users where its severe corrosive properties will provide for sufficient protection to exposure.
According to ANNEX VII column 2 of the REACH regulation no testing for dermal sensitisation is required for corrosive substances. Further testing is not mandatory also based on animal welfare grounds.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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