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EC number: 202-318-7 | CAS number: 94-26-8
Ames test (OECD 471): negative in S. typhimurium TA92, TA1535, TA100, TA 1537, TA94 and TA98 with metabolic activation
A read-across approach was additionally conducted on source substance isobutyl 4-hydroxybenzoate:
Ames (OECD 471): not mutagenic in S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A with and without metabolic activation
A bacterial gene mutation assay with butyl 4 -hydroxybenzoate was performed to a protocol similar to OECD Guideline 471 (Ishidate, 1984). In this study the substance was not mutagenic in any of the six S. typhimurium strains (TA92, TA1535, TA100, TA 1537, TA94 and TA98) tested with metabolic activation up to 1 mg/plate.
There is one limited study on the bacterial mutagenicity of target substance butyl 4 -hydroxybenzoate available. The assessment of bacterial mutagenicity was additionally based on a study conducted with source substance isobutyl 4 -hydroxybenzoate as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance structurally closest to the target substance is chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
CAS 94 -26 -8
A bacterial gene mutation assay with the target substance butyl 4 -hydroxybenzoate was performed to a protocol similar to OECD Guideline 471 (Ishidate, 1984). In this study the substance was not mutagenic in any of the six S. typhimurium strains (TA92, TA1535, TA100, TA 1537, TA94 and TA98) tested with metabolic activation up to 1 mg/plate.
Mutagenic activity of isobutyl 4-hydroxyparaben was investigated in a bacterial reverse mutation assay (Ames test; test strains used: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A according to OECD 471 (Verbaan, 2016).Test concentrations up to 1,600 µg/plate were tested in the experiment. The test compound proved to be not mutagenic to the bacterial strains.
Based on the available data (weight of evidence) and following the analogue approach, butyl 4-hydroxybenzoate is not expected to be mutagenic in bacteria.
Overall concusion for genetic toxicity:
In the literature further data on genotoxicity are available on butyl 4-hydroxybenzoate. Butyl 4-hydroxybenzoate was shown to cause sister-chromatid exchange (SCE), structural chromosome aberration (CA), and DNA migration in the comet assay in Chinese hamster cells in vitro at 0.75 mM (equivalent to 0.146 mg/mL) (Tayama et al., 2007). In contrast, three publications show negative results for chromosomal aberration in Chinese hamster cells (Ishidate et al., 1984; Ishidate at al., 1978; Yoshida et al., 1978). Further, in an in vivo comet assay according to OECD 489 the test substance did not induce DNA damage in any observed organ at the limit dose of 2000 mg/kg bw (Sasaki et al., 2002).
Overall, the majority of available genotoxicity tests for butyl 4-hydroxybenzoate in mammalian cells in vitro and in vivo show negative results. Thus, butyl 4-hydroxybenzoate is not considered to be mutagenic or clastogenic.
Ishidate, M. et al. (1978) Cytotoxicity test on medical drugs. Chromosome aberration tests with Chinese hamster cells in vitro.Eisei Shikensho Hokoku 96:55--61.
Ishidate, M. et al. (1984) Primary mutagenicity screening of food additives currently used in Japan. Food Chem Toxicol 22:623--636.
Sasaki, Y. F. et al. (2002) The comet assay with 8 mouse organs: results with 39 currently used food additives. Mutation Research 519 (2002):103–119
Tayama S. et al. (2007) Genotoxic effects of environmental estrogen-like compounds in CHO-K1 cells.Mutation Research 649 (2008):114–125
Yoshida, S. et al. (1978) Cytogenetic studies of antimicrobials on cultured cells. Tokyo Toritsu Eisei Kenkyusho Kenkyo Nempo (Annu. Rep. Tokyo Metrop. Res. Lab. Public Health) 29(2): 86-88 1978
Therefore, based on the read-across approach and on data available for the target substance itself, the available data on genetic toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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