Alkenes, C11-12, hydroformylation products, low boiling

Endpoint summary

Additional information

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol. As defined in the Read-across Justification Document in section 13, data provided for these constituents when considered together is representative of Alchisor TAL 123 and suitable for assessment purposes. Study data for each constituent has been evaluated. In a protective approach the most sensitive study result from across the three constituents has been identified and used to address the hazard endpoint in question.

 

In vitro

 

16 studies are presented in relation to the assessment of Alchisor TAL 123's in vitro mutagenicity. This endpoint is addressed by data from constituents of Alchisor TAL 123. Specifically two studies and 4 read across entries for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), 3 studies with dodecan-1-ol in addition to 3 read across entries for dodecan-1-ol. In addition 4 read across entries are presented for undecan-1-ol. Adequate reliable data is available for each constituent. Therefore using a protective approach the dataset is a reliable adequate basis for Alchisor TAL 123 assessment purposes.

 

A suite of mutagenicity studies were conducted on C9-14 aliphatics (2-25% aromatics), including the Ames test and in vitro chromosome aberration test. Read across data from two in vitro chromosome aberration studies, an ames study and a mammalian cell gene mutation study were also provided. All these in vitro studies were negative for mutagenicity.

 

No substance specific information is available for undecan-1-ol. Key studies were chosen from studies on closely related linear or branched alcohols of similar chain length. The choice of key study was based on reliability and similarity of chain length. Read across data presented included an ames study and two mammalian gene cell mutagenicity tests. The data available from standard in vitro genetic toxicity assays from all the related substances shows no evidence of mutagenic potential. Accordingly undecan-1-ol has no in vitro mutagenic potential.

 

In vitro mutagenicity information is available for dodecan-1-ol from three reliable (Klimisch score 2) bacterial mutagenicity study, and from an in vivo mouse micronucleus assay. The results of both of these studies were in agreement. For endpoints where there is no information on dodecan-1-ol, key studies were chosen from studies on closely related linear or branched alcohols of similar chain length. The choice of key study was based on reliability and similarity of chain length. The data available from standard in vitro and in vivo genetic toxicity assays for all related substances show no evidence of mutagenic potential.

 

In vitro mutagenicity study reports presented for constituents of Alchisor TAL 123 indicate a lack of mutagenic potential. Consequently following the protective approach as detailed above, Alchisor TAL 123 is described as non-mutagenic.

 

In vivo

 

The in vivo mutagenicity of Alchisor TAL 123 was assessed by evaluating studies from the three constituents. In this instance 3 read across studies were provided for the Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). An in vivo micronucleus assay with dodecan-1-ol was used in support of the in vivo mutagenicity assessment of both dodecan-1-ol and undecan-1-ol. Adequate reliable data is available for each constituent. Therefore using a protective approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes. The data available from standard in vivo genetic toxicity assays for all related substances show no evidence of mutagenic potential.

 

It should be noted that an in vivo dominant-lethal inhalation study (7.8.1 Toxicity to Reproduction, ExxonMobil 1980) conducted in rats in relation to the Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) was negative for mutagenicity at the maximum concentration of 300 ppm after 8 weeks of daily exposure via inhalation. No mutagenic, reproductive, developmental, or histopathological effects were observed.

 

In vivo mutagenicity study reports presented for constituents of Alchisor TAL 123 indicate a lack of mutagenic potential. Consequently following the protective approach as detailed above, Alchisor TAL 123 is described as non-mutagenic.

Short description of key information:
In Vitro

C9-C14 aliphatic hydrocarbons (2-25% aromatics)
Ames test (DHC 1984a. Report No. 84/BP0004-011/245 [Hydrocarbons, C11-C14, n alkanes, isoalkanes, cyclics, aromatics (2-25%)]), negative.

In vitro mammalian chromosome aberration test (DHC 1984b. Report No. 84/BP0004-011/245 [Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)]), negative.

In Vitro Sister Chromatid Exchange Assay in Mammalian Cells 'read across' (API 1987. [Hydrodesulfurized kerosene]), negative.

Undecan-1-ol
Ames test 'read across' (Thompson 1996. [dodecan-1-ol]), negative

Mammalian cell gene mutation study 'read across' (Iglesias 2002), negative

Mammalian cell gene mutation study 'read across' (Kirby 1983), negative.

In vitro mammalian chromosome aberration test 'read across' (van Delft 1998), negative

Dodecan-1-ol
Ames test (Thompson 1996 [dodecan-1-ol]), negative

In vitro mammalian chromosome aberration test 'read across' (van Delft 1998), negative

Mammalian cell gene mutation study 'read across' (Iglesias 2002), negative

In Vivo

C9-C14 aliphatic hydrocarbons (2-25% aromatics)
Mammalian bone marrow chromosome aberration test 'read across' (Gochet 1984. [White Spirits]), negative.
Mammalian Erythrocyte Micronucleus Test 'read across' (McKee 1994. [Turbo Fuel A]), negative.

Undecan-1-ol
Mammalian Erythrocyte Micronucleus Test 'read across' (Banduhn 1992. [dodecan-1-ol]), negative.

Dodecan-1-ol
Mammalian Erythrocyte Micronucleus Test (Banduhn 1992. [dodecan-1-ol]), negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The negative results using in vitro and in vivo genotoxicity assays do not warrant the classification of Hydrocarbons C11-14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) fluids as genotoxins. Undecan-1-ol and dodecan-1-ol are members of the category aliphatic alcohols. The category members contain no structural elements which may be of concern for potential mutagenic activity. In vitro tests over the carbon range (C6-22) of the long chain alcohols category members (primary aliphatic alcohols) and supporting substances (C5-C24-34) are negative including a bacterial mutagenicity study. In addition an in vivo mouse micronucleus study exists which reports no mutagenic potential for dodecan-1-ol. The evidence presented supports the conclusion that these alcohols are not genotoxic in vivo. Consequently Alchisor TAL 123 is not classified as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).