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Description of key information

NOAEL (21 day oral, dw)) > 444mg/kg/day (female)
NOAEL (21 day, oral, dw) > 500mg/kg/day (male)
NOAEL (2 day, oral, gav) > 400mg/kg/day (male)
NOAEL (4 day, oral, gav) = 1000mg/kg/day (female)

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
1 000 mg/kg bw/day

Additional information

In a study to evaluate the effects on the immune system of 2 -butoxyethanol (2BE) exposure, male and female rats were exposed through drinking water exposure to doses of up to 450 -500mg/kg/day for 21 days. Measures of cellular and humural immune function were assessed, including NK cell function, deleyd type hypersensitivity reaction, IL2, interferon and serum IgG production. No effects were seen on the thymus. Natural killer cytotoxic responses were enhanced in male and female rats treated with the low dose of 2BE, but only by around 6 -13% and the effect was not seen in the high dose animals. No effect on antibody production nor DTH reactions was observed. The authors concluded that the immune system is not a sensitive target for 2BE. This was confirmed in another study to assess the response of rats antibody response to TNP-LPS when treated acutely with 2 -butoxyethanol at doses up to 400mg/kg, which showed no evidence of immunosuppressive effects at doses which produced lethal general toxicity.

In a study to assess the effects on the immune system of 2-butoxyethanol, mice were subject to repeat dermal application over a period of 4 days at doses up to 1500mg/kg. The study reported increased splenic cellularity and spleen/body weight ratios at the highest dose. Reduced splenic T cell proliferative and mixed lymphocyte responses were also reported but without a clear dose response relationship. There was no effect on the thymus, on B cell proliferation, humoral immunity parameters, a cytotoxic T lymphocyte assay or NK cell activity.

The conclusion drawn from the studies available is that immunotoxicity is not an important characteristic of 2 -butoxyethanol

Justification for classification or non-classification

No biologically plausible adverse effects seen at levels below 1000mg/kg/day. No classification required.