Human health
The presence of AE in household detergents gives rise to a variety of possible
consumer contact scenarios including direct and indirect skin contact from its use in
laundry detergents, inhalation through the use of spray cleaners and oral ingestion
derived from residues deposited on dishes. The aggregate consumer exposure to AE
has been conservatively estimated to be at maximum 6.48 μg/kg bw/day.
A substantial amount of toxicological data and information in vivo and in vitro
demonstrates that there is no evidence for AEs being genotoxic, mutagenic or
carcinogenic. No adverse reproductive or developmental effects were observed. The
majority of available toxicity studies revealed NOAELs in excess of 100 mg/kg bw/d
but the lowest NOAEL for an individual AE was established to be 50 mg/kg bw/day.
This value was subsequently considered as a conservative, representative value in the
risk assessment of AE. The effects were restricted to changes in organ weights with
no histopathological organ changes with the exception of liver hypertrophy (indicative
of an adaptive response to metabolism rather than a toxic effect). It is noteworthy that
there was practically no difference in the NOAEL in oral studies of 90-day or 2 years
of duration in rats. A comparison of the aggregate consumer exposure and the
systemic NOAEL (taking into account an oral absorption value of 75%) results in a
Margin of Exposure of 5,800. Taking into account the conservatism in the exposure
assessment and the assigned systemic NOAEL, this margin of exposure is considered
more than adequate to account for the inherent uncertainty and variability of the
hazard database and inter and intra-species extrapolations.
AEs are not contact sensitizers. Neat AE are irritating to eyes and skin. The irritation
potential of aqueous solutions of AEs depends on concentrations. Local dermal effects
due to direct or indirect skin contact in certain use scenarios where the products are
diluted are not of concern as AEs are not expected to be irritating to the skin at in-use
concentrations. Potential irritation of the respiratory tract is not a concern given the
very low levels of airborne AE generated as a consequence of spray cleaner aerosols
or laundry powder detergent dust.
In summary, the human health risk assessment has demonstrated that the use of AE in
household laundry and cleaning detergents is safe and does not cause concern with
regard to consumer use.