Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The submission substance was not mutagenic in a range of in vitro and in vivo genotoxicity assays. In a bacterial test, the submission substance was not mutagenic in Salmonella strains tested in the presence or absence of metabolic activation. It was also not cytogenic in an in vitro mammalian cell assay and when tested in an in vivo mouse bone marrow micronucleus assay.   All studies were conducted in a manner similar or equivalent to currently established OECD guidelines. All available data indicate the submission substance is non-genotoxic.

Read Across Justification

Category or groups of chemicals that have similar structural features generally are expected to have similar properties as well as similar toxicological characteristics that are predictable across the group in a homologous or structurally analogous series.  Therefore, the use of surrogates having close structural similarities and the same chemical group functionality as in the case of the alkylated naphthalenes would be appropriate for read-across for“a mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes”.

 

“A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes”is a C14-alkylated naphthalene and is also described as MCP 2484, and MCP 968 in this document.

 

“Reaction products of 1-hexadecene and naphthalene” is a C16-alkylated naphthalene and is also described as MCP 917. “Reaction products of 1-hexadecene and naphthalene” is already registered under REACH.

A chemical category groupis a group of chemicals whose physico-chemical and human health and/or environmental toxicological properties and/or environmental fate properties are likely to be similar or follow a regular pattern as a result of structural similarity (i.e., structural analogues). Under REACH, Annex XI allows for the chemical safety assessment of chemicals by the use of this chemical category group or analog approach; see Chapter R.6.2. of the ECHA guidance document (ECHA 2008) for discussion. Based on the close chemical similarity between“a mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes”and its alkylated naphthalene analogues, we believe that the read-across data for“reaction products of 1-hexadecene and naphthalene” are adequate to support hazard characterization ofthe submission substance.


Short description of key information:
In vitro, gene mutation in bacteria, 1 key study, Negative (equivalent or similar to OECD TG 471)
In vitro, chromosome abberation in mammalian cells, 1 key study, Negative (according to OECD TG 473)
In vitro, gene mutation in mammalian cells, 1 key study, read-across, Negative (equivalent or similar to OECD TG 476).
In vivo, Cytogenicity, 1 key study, Negative (equivalent or similar to OECD 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The negative results in in vitro and in vivo genotoxicity assays do not warrant classification of the submission substance as a genotoxin or a clastogen under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.