Registration Dossier

Administrative data

Description of key information

Data are available for the acute toxicity of hexyl acetate following oral, dermal and inhalation exposure.  Low toxicity is demonstrated for all exposure routes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
41 500 mg/kg bw
Quality of whole database:
A screening study provides limited methodological data but is sufficient for the purposes of hazard characterisation and classification.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
3 µg/m³
Quality of whole database:
In the acute study the results from the study are expressed in duration of exposure survived at the highest non-adverse concentration but the actual concentration used was not reported . The reliability of using the repeated exposure study to address acute endpoints is reduced because the doses administered wre not selcted to give maximal acute exposures.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Two studies are available and report acute dermal LD50 values of >5000 and >20000 mg/kg bw.

Additional information

The acute oral LD50 of hexyl acetate in the rat is shown to be 41.5 mL/kg bw (~41.5 g/kg bw). Two studies of acute dermal toxicity in the rabbit report LD50 values of >5000 mg/kg bw and >20 mL/kg bw (~20 g/kg bw). No mortality is reported in a screening study in rats exposed for 8 hours to a saturated vapour concentration of hexyl acetate.


Justification for selection of acute toxicity – oral endpoint
Only one study available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint
The repeated exposure study was used as the key indicator of the absence of acute effects. At the maximum atmosphere concentration there were no adverse effects indicative of acute toxicity (or repeated exposure toxicity) observed following exposure to atmospheres with concentrations of 500, 1500 or 3000 ppm.
This was supported by an LC50 determination that indicated no adverse effects were observed in rats exposed at the MTD for 8 hours.

Justification for selection of acute toxicity – dermal endpoint
This study reports a lower LD50 value

Justification for classification or non-classification

The results of acute oral, dermal and inhalation toxicity studies do not trigger the classification of hexyl actetate for acute toxicity according to the CLP Regulation.