Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

The Annex VIII of the REACH regulation requires an assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information.

Key value for chemical safety assessment

Additional information

The Annex VIII of the REACH regulation requires an assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information. There is no available data on the toxicokinetics of the chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar’ and ar’’-Me derivs (CAS No. 92257-28-8). Toxicokinetics is essentially the study of "how a substance gets into the body and what happens to it in the body". Four processes are involved in toxicokinetics; namely absorption, distribution, metabolism and excretion (ADME). It may be noted that the chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar’ and ar’’-Me derivs (CAS No. 92257-28-8)is a dark red clear liquid r having applications such as use in Colorant for petroleum products and dyeing. Since the chemical is not a food dye, it is unlikely to be ingested and there is a low possibility of the chemical exerting a toxic effect after ingestion. The chemical is expected to have low potential for absorption across biological membranes due to the very low solubility in water and corresponding high partition coefficient value of Log Pow = 8.2101. As per the Lipinski rule, chemical having Log Pow greater than 3 are not readily bioavailable. Thus, these chemicals even if ingested are expected to be excreted out of the human body unchanged. Thus, the likelihood of inhalation of these particles is low. Thus, considerign the use of this chemical as well as the fact that oral and inhalation exposure are very unlikely, the end point of toxico-kinetics was considered for waiver.