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Administrative data

Description of key information

Oral LD50 data in rats:  >5000 mg/kg
Dermal LD50 in rabbits: >3000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
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 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.

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 acute toxicity of the ethylene glycol ether butyl series decreases with increasing molecular weight as demonstrated by the data available on the first three members of the series. Therefore, TEGBE is expected to be more toxic than TetraEGBE and using data from a study using pure TEGBE to estimate the skin irritation potential of a multi-constituent substance of TEGBE-TetraEGBE will be a conservative approach. It seems reasonable to predict by extrapolation that TetraEGBE will have an acute toxicity no higher than TEGBE and therefore the multi-constituent substance TEGBE-TetraEGBE will have both oral and dermal LD50’s no lower than TEGBE. Since neither are lower than 2000mg/kg the substance does not require classification for acute toxicity.