Registration Dossier

Administrative data

Description of key information

Oral LD50 data in rats:  6650, 5170 mg/kg
Dermal LD50 in rabbits: 3540 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 170 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 540 mg/kg bw

Additional information

Acute oral toxicity data is only available for rats.  In a reliable acute oral toxicity study where original data is available, male and female rats were subjected to doses of up to 6400ml/kg of 2-(2-(2-butoxyethoxy)ethoxy)ethanol and subsequently observed for a period of 14 days. An LD50 value of ~5170mg/kg was obtained.  In an old study report where only basic experimental details were reported, an LD50 of 6650mg/kg was established in male rats for the substance 2 -(2 -(2-butoxyethoxy)ethoxy)ethanol.  In an acute oral toxicity study in male rats for which only basic details are available from a secondary source, an LD50 of 5300mg/kg was established for the same substance. The most reliable study is the former. However, the lowest value from the supporting studies is used to define the LD50. In a poisoning case, a young child self administered a huge dose estimated in excess of 25g/kg of a formulated brake fluid based on triethylene glycol ethers. Whilst intensive medical support was briefly required, the patient made a full recovery

The vapour pressure for 2 -(2 -(2-butoxyethoxy)ethoxy)ethanol is so low  that no exposure is likely via the inhalation route and therefore no hazard would be expected by the inhalation route , bearing in mind the low  toxicity by other routes. 

In an acute dermal toxicity in rabbits, an LD50 of 3540mg/kg was obtain for the substance 2 -(2 -(2-butoxyethoxy)ethoxy)ethanol. Exposure was under occluded conditions. Information available suggests the dose response curve is unusually shallow.  In a dermal acute toxicity limit test in rabbits for which only limited information is available from a secondary source, no deaths were seen in animals treated with a single 2000mg/kg dose of the same test substance.  Exposure was carried out for 24 hours under occlusive conditions and the animals observed for 14 days.

It should be noted that whilst the LD50 by the oral route unusually is greater than that for the dermal route, the values obtained are for different species and are therefore not directly comparable.

Justification for classification or non-classification

The LD50 by the dermal route and the oral route are greater than the cut off dose of 200mg/kg and therefore classification is not required. No adverse effects are seen following inhalation exposure to saturated vapour concentrations and therefore no classification by this route is required.