Registration Dossier

Administrative data

Description of key information

Oral LD50 data in rats: 1 study on the registered substance, LD50 >2000 mg/kg

Dermal LD50 in rabbits >2000 mg/kg (on a compenant of the registered substance substance)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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

Additional information

An acute oral toxicity study performed in rats on the registered substance, the acute oral LD50 ofwas determined to be greater than 2000 mg/kg/bw.

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 similar substance 2 -(2 -(2-butoxyethoxy)ethoxy)ethanol. Exposure was under occluded conditions. Information available suggests the dose response curve is unusually shallow. The data suggests significant absorption potential through skin but that absorption is <100%.

Read across is justified since toxicity decreases with increasing molecular weight within a given alkyl homologous series so the lowest molecular weight major component of this substance, (2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, is likely to be the most toxic (or in this case the "least non-toxic") component and data from it can be considered as a conservative surrogate for the toxicity of the UVCB substance "Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy" as a whole, as is the case for dermal toxicity.

Justification for classification or non-classification

The LD50 by the dermal route and the oral route are greater than the cut off dose of 2000mg/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.