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Key value for chemical safety assessment

Additional information

One key gene mutation study in bacteria was identified for 1 -dodecene dimer with 1 -decene, hydrogenated. Read-across studies for in vitro cytogenicity in mammalian cells and gene mutation in mammalian cells were identified within category or from structural analogues. For 1 -dodecene dimer with 1 -decene, hydrogenated, strains TA 98, TA 100, TA 1535, and TA 1537 ofS. typhimurium and Escherichia coli strain WP2 uvrA were exposed to Oronite XS 101 in acetone at concentrations of 0; 100; 330; 1000; 3330; or 10,000 μg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method (Macado, 1989). There was no evidence of induced mutant colonies over background.

Read across from Alkane 4 was used to assess the potential of cytogenicity in mammalian cells (Wright, 1995). Human lymphocyte cultures from a healthy volunteer were exposed to Alkane 4 in ethanol at concentrations of 0, 39, 78.1, 156.25, 31 2.5, 625, 1250, 2500 and 5000μg/mL with or without metabolic activation in the first experiment (Experiment 1) and at concentrations of 625, 1250, 2500 and 5000μg/mL (Experiment 2) for 20 hours or 1250, 2500, and 5000 μg/mL (Experiment 2) for a 44 hour harvest time.

 

Alkane 4 did not induce chromosomal aberrations or polyploidy cells with or without metabolic activation. Positive controls, ethyl methanesulfphonate in the absence of S9, and cyclophosphamide in the presence of S9, gave an appropriate response. Based on these results Alkane 4 is considered non-clastogenic to human lymphocytes in vitro when tested at concentrations ≤ 5000 µg/mL.

 

Read across from Alkane 4 also was used to assess the potential of gene mutation. In a study by Pant (2000), Chinese hamster ovary (CHO) cells culturedin vitrowere exposed to Alkane 4 in ethanol at concentrations of 0, 313, 625, 1250, 2500, or 5000 μg/mL in the presence and absence of mammalian metabolic activation (S9) for 4 hours.

 

At 625 μg/mL with metabolic activation, a significant response was observed; however, the increase was not significant when it was compared to the historical, cumulative solvent control data. The same was true for the test article concentration of 2500 µg/mL, with activation, in the confirmatory mutation assay. The increase in the number of mutants was not significant when compared to historical, cumulative solvent control data. The response seen in the definitive mutation assay at 625 μg/mL was not reproduced in the confirmatory assay. Thus, the test article Alkane 4 was not considered to have caused a significant increase in the mutant frequency at the HGPRT locus among the test article-treated cultures in the presence and absence of exogenous metabolic activation. There was no dose-dependent response in the test article treated cultures. The mutant frequencies of the test article solvent and the solvent for the positive controls were within the historical negative control values.

One key in vivo genetic toxicity study was identified for1-dodecene dimer with 1-decene, hydrogenated. In this study, 18/sex/dose were treated with a single intraperitoneal injection of Oronite XS 101 at doses of 0, 1250, 2500, or 5000 mg/kg bw (Machado, 1989). Bone marrow cells were harvested at 24, 48, and 72 hours post-treatment from 5 mice/sex/group/time point. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time.

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for poly alpha olefins using Alkane 4 and Alkane 5 as an analogue. Alkane 4 and Alkane 5, like other compounds in this category, are poly alpha olefins, i. e., highly branched isoparaffinic chemicals produced by oligomerization of oct-1-ene, dec-1-ene, and/or dodec-1-ene. Therefore their physiochemical and toxicological properties are expected to be similar to those of other poly alpha olefins.


Short description of key information:
One key gene mutation study in bacteria (OECD 471) was identified for 1-dodecene dimer with 1-decene, hydrogenated. Read-across studies for in vitro cytogenicity in mammalian cells (OECD 473) and gene mutation in mammalian cells (OECD 476) were identified within category or from structural analogues. One key in vivo gene mutation study (OECD 474) was identified for 1-dodecene dimer with 1-decene, hydrogenated.

All genetic toxicity tests, both in vitro and in vivo, were negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All read-across in vitro genetic toxicity studies (i. e., gene mutation studies in bacteria; cytogenicity studies in mammalian cells; and gene mutation studies in mammalian cells) from substances within category or from structural analogues showed negative results. Identified in vivo mouse micronucleus studies also produced no evidence of mutagenic effects. Based on the results of the read-across studies,1-dodecene dimer with 1-decene, hydrogenated is unlikely to be mutagenic and does not meet the criteria for classification and labelling as described in EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.