International Agency for Research on Cancer (IARC) - Summaries & Evaluations


VOL.: 40 (1986) (p. 123)

CAS No.: 25013-16-5
Chem. Abstr. Name: (1,1-Dimethylethyl)-4-methoxyphenol

5. Summary of Data Reported and Evaluation

5.1 Exposure

Butylated hydroxyanisole (BHA) has been used since 1947 as an antioxidant in many foods, including edible fats and oils, meats, cereals, potato products, baked goods, nuts, snack foods, chewing-gum and beverages. It has also been used extensively in cosmetics, especially lipsticks and eye shadow. There is widespread human exposure to this compound by ingestion and skin application.

5.2 Experimental data

Butylated hydroxyanisole was tested for carcinogenicity in two experiments in rats and in two experiments in hamsters by administration in the diet, inducing benign and malignant tumours of the forestomach.

Butylated hydroxyanisole was studied in mice and rats for its ability to modify the carcinogenicity of selected chemical agents. When administered with known carcinogens, butylated hydroxyanisole either enhanced, inhibited or had no effect on carcinogenicity.

Butylated hydroxyanisole administered to rats at maternally toxic and occasionally lethal doses during, or before, during and after, gestation induced slight embryotoxicity but no definite indication of teratogenicity. No effect was seen in rabbits, pigs or rhesus monkeys.

In rats, feeding of butylated hydroxyanisole in the diet caused superficial necrosis, ulceration and hyperplasia of the squamous epithelium of the forestomach. Induction of forestomach hyperplasia also occurs in hamsters. Administration of butylated hydroxyanisole by gavage to monkeys was associated with an elevated mitotic index in the squamous epithelium of the distal oesophagus.

Butylated hydroxyanisole was not mutagenic to Salmonella typhimurium, Drosophila melanogaster or to Chinese hamster cells in vitro. It did not cause chromosomal effects in D. melanogaster or in cultured Chinese hamster cells.

When tested in combination with other chemicals (usually known mutagens or carcinogens), butylated hydroxyanisole often modified their DNA damaging, mutagenic and clastogenic activities. In most studies, butylated hydroxyanisole reduced the activity of indirectly-acting mutagens/carcinogens.

5.3 Human data

No data were available to evaluate the carcinogenicity of butylated hydroxyanisole to humans.

5.4 Evaluation

There is sufficient evidence for the carcinogenicity of butylated hydroxyanisole to experimental animals.

No data were available on the carcinogenicity of butylated hydroxyanisole to humans.

For definition of the italicized terms, see Preamble Evaluation.

Subsequent evaluation: Suppl. 7 (1987) (p. 59: Group 2B)


Last updated: 22 April 1998

    See Also:
       Toxicological Abbreviations
       Butylated hydroxyanisole (BHA) (WHO Food Additives Series 15)
       Butylated hydroxyanisole (BHA) (WHO Food Additives Series 18)
       Butylated hydroxyanisole (BHA) (WHO Food Additives Series 42)