Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Non-human information

 

In vitro data

The key studies are considered to be a bacterial mutation assay (Harlan Laboratories, 2010a), a mammalian cell gene mutation assay (Harlan Laboratories, 2010b) and a mammalian cell cytogenetic assay (Harlan Laboratories, 2010c).  These are three recognised core assay types for investigating mutation in vitro.

Acetylene was tested in an Ames plate assay modified to allow exposure to a gaseous material (Harlan Labortaories, 2010a). S. typhimurium strains TA1535, TA1537, TA98 and TA100, together with E.Coli strain WP2uvrA were used with exposures carried out both with and without auxiliary metabolic activation (S9).  A range of doses was used from 0.5 to 50% atmospheres.  Acetylene was negative in this assay. 

In the mammalian cell gene mutation assay (Harlan Laboratories, 2010b), mouse lymphoma (L5178Y) cells were exposed to acetylene in a contained system in both the absence and presence of S9, again at doses up to 50% atmosphere.  Exposure times of 4 hours (+/- S9) and 24 hours (-S9) were used.  Acetylene was negative in this assay. 

In the mammalian cell cytogenetic assay (Harlan Laboratories, 2010c), CHL cells were exposed to acetylene in a contained system in both the absence and presence of S9, at doses up to 1.25% atmosphere. Exposure times of 6 hours (+/- S9) and 24 hours (-S9) were used. Acetylene was negative in this assay, both for endpoints of chromosomal damage and also numerical changes. 

 

In vivo data

There are no in vivo mutagenicity data for acetylene.  Acetylene has been examined for mutagenic activity in vitro in a range of recognised core assay types, examining for endpoints of gene mutation, chromosomal damage and chromosomal numerical changes, and was negative in all assays.  There are no data to indicate any likely genotoxic activity for acetylene in vivo.

 

 

Human information

There is no information indicating any adverse effects of acetylene.


Short description of key information:
Acetylene has been examined for mutagenicity in vitro in a range of recognised core assay types, examining for endpoints of gene mutation, chromosomal damage and chromosomal numerical changes. It has shown negative results in all assays. It is concluded that the available data indicate that acetylene has no significant genotoxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

It is concluded that the available data indicate that acetylene does not warrant classification under CLP.