Registration Dossier

Administrative data

Description of key information

ORAL:
Mouse, male: LD50=7128mg/kg (fasted animals), 8188mg/kg (fed animals)
Rat, male: LD50=7128mg/kg (fasted animals), 12410mg/kg (fed animals), >5000mg/kg
Rat, male/female: LD50=9210mg/kg, ~6500mg/kg, 6700ml/kg
Guinea pig, male/female: LD50=4160mg/kg
Cat: LD50>4080mg/kg
Rabbit; LD50=>4000mg/kg, 6.3g/kg
INHALATION:
LD50 greater than saturated vapour pressure
DERMAL
Rabbit, male: LD50=9404mg/kg
Rabbit: LD50=8980ml/kg (9284mg/kg)
Guinea pig: LD50>10g/kg, LD50 5-8g/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
4 160 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
9 284 mg/kg bw

Additional information

A number of reliable studies plus supporting information are available in multiple species for the acute oral toxicity of 2 -(2 -methoxyethoxy)ethanol. A well documented study which looked at both fasted and unfasted animals showed that mice were more sensitive than rats with fasted animals (not surprisingly) more sensitive than fed animals. The lowest value seen was 7128mg/kg for fasted rats and mice. The full results are shown in the key information field. Other studies reported consistent figures for the LD50 in these two species. A single value for the guinea pig of 4160mg/kg was reported in a reliable study and this is used to derive the key parameter for the oral route.

There is one reliable study plus a supporting study which both that acute toxicity by the dermal route is low. All the studies were in rabbits. The key study showed a dermal LD50 of 9404mg/kg. The supporting reports an LD50 of 9284mg/kg. The result from the key study is used as the key parameter

The vapour pressure for 2 -(2 -methoxyethoxy)ethanol is very low. In an acute toxicity study by the inhalation route, rats were exposed to the saturated vapour concentration of 2 -(2 -methoxyethoxy)ethanol, estimated to be 1.2mg/l, for a period of 8 hours. No mortality was observed. Clearly, the substance has a low acute toxicity by the oral route. Along with supporting data from other studies, there is sufficient information available to conclude that there is no acute hazard by the inhalation route.

Justification for classification or non-classification

The rat and mouse are the two species normally used for acute oral toxicity classification. The values obtained for these species are greater than the threshold for classification. Values for other species also fall outside the range for classification.

Acute toxicity data by the dermal route clearly shows that the LD50 is greater than the threshold for classification.

The low vapour pressure of the substance plus limited short term exposure information available for the inhalation route shows that the substance is of low toxicity by the inhalation route and does not meet the criteria for classification.