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Administrative data

Key value for chemical safety assessment

Additional information

Alchisor TAL 145 can be characterized according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-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 145 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 endpoint in question.

 

In vitro

 

As detailed in Table 1 below, 14 genotoxicity related study reports are available for constituents of Alchisor TAL 145. Adequate reliable data is available for each constituent. Therefore using our protective approach the dataset is a reliable adequate basis for Alchisor TAL 145 assessment purposes.

 

Table 1: In Vitro Genotoxicity Key/Supporting Studies for Constituents of Alchisor TAL 145

 

 

Constituents of Alchisor TAL 145

 

Reference

Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%)

Dodecan-1-ol

Tetradecan-1-ol

DHC 1984a

Key

 

 

DHC 1984b

Key

 

 

Gochet 1984

Supporting (read across)

 

 

Conaway 1982a

Supporting (read across)

 

 

Conaway 1982b

Supporting (read across)

 

 

API 1987

Key (read across)

 

 

Henkel 1982

 

Supporting

 

Shimuzu 1985

 

Supporting

 

Thompson 1996a

 

Key

 

Sasol 1998

 

Key (read across)

Key (read across)

Kirby 1983

 

Key (read across)

Key (read across)

Iglesias 2002b 1

 

Key (read across)

Key (read across)

Thompson 1996b

 

 

Key

Iglesias 2002b 2

 

 

Key (read across)

 

 

A suite of mutagenicity studies were conducted on Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), including a bacterial cell gene mutation assay and an in vitro chromosome aberration test. Read across data from three mammalian cell gene mutation assays and a bacterial cell gene mutation assay was also presented. All these in vitro studies were negative for mutagenicity.

 

In vitro mutagenicity information is available for dodecan-1-ol from three reliable (Klimisch score 2) bacterial cell gene mutation assays. The results 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. Read across data is presented from an in vitro mammalian chromosome aberration assay and two mammalian cell gene mutation assays. The data available from standard in vitro genetic toxicity assays for all related substances show no evidence of mutagenic potential.

 

The mutagenicity assessment of tetradecan-1-ol is supported by a bacterial cell gene mutation assay. In addition read across data is presented in the form of two mammalian chromosome aberration studies and two mammalian cell gene mutation assays. Results from all these studies were negative.

 

In vitro mutagenicity study reports presented for constituents of Alchisor TAL 145 indicate a lack of mutagenic potential. Consequently following the protective approach as detailed above, Alchisor TAL 145 is described as non-mutagenic.

 

In vivo

 

As detailed in Table 2 below, 5 in vivo genotoxicity related study reports are available for constituents of Alchisor TAL 145. Adequate reliable data is available for each constituent. Therefore using our protective approach the dataset is a reliable adequate basis for Alchisor TAL 145 assessment purposes.

 

Table 2: In Vivo Genotoxicity Key/Supporting Studies for Constituents of Alchisor TAL 145

 

 

Constituents of Alchisor TAL 145

 

Reference

Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%)

Dodecan-1-ol

Tetradecan-1-ol

Banduhn 1992

 

Key

Key (read across)

Iglesias 2002b

 

 

Key (read across)

Gochet 1984

Key (read across)

 

 

Conaway 1982

Supporting (read across)

 

 

McKee 1994

Key (read across)

 

 

 

A single mammalian erythrocyte micronucleus test is provided in support of dodecan-1-ol.Read across data is presented in support of the in vivo mutagenicity assessment of the both the Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and tetradecan-1-ol. Read across data for the Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is provided by two mammalian bone marrow chromosome aberration tests and a mammalian erythrocyte micronucleus test. Tetradecanol is supported by read across data from two mammalian erythrocyte micronucleus tests. 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 C9-C14 aliphatics (2-25% aromatics) 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 145 indicate a lack of mutagenic potential. Consequently following th protective approach as detailed above, Alchisor TAL 145 is described as non-mutagenic.


Short description of key information:
In Vitro

Genetic Toxicity in vitro - Negative - Bacterial reverse mutation assay (OECD TG 471)

Genetic Toxicity in vitro - Negative - In vitro Mammalian Chromosome Aberration Test (OECD TG 473)

Genetic Toxicity in vitro - Negative - In vitro Mammalian Cell Gene Mutation Test (OECD TG 476)

Genetic Toxicity in vitro - Negative - In vitro Sister Chromatid Exchange Assay in Mammalian Cells (OECD TG 479) - Read-Across from Hydrodesulfurized Kerosene

In vivo

Genetic Toxicity in vivo - Negative - Micronucleus Assay in Mouse Bone Marrow (OECD TG 474) - Read-Across from Jet Fuel A

Genetic Toxicity in vivo - Negative - Mammalian Bone Marrow Chromosome Aberration Test (OECD TG 475)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The negative results from in vitro and in vivo genotoxicity assays do not warrant the classification of Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) fluids as genotoxins. Dodecan-1-ol and tetradecan-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 145 is not classified as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.