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Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
5 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Based on observations from other members of this category, it can be concluded that the data from TEGME is a good conservative surrogate to predict the properties of this substance and that it will have low repeat dose toxicity by all routes of exposure.  NOAELs can be predicted from TEGME after taking into account molecular weight differences. Further data from sub-acute studies with the substance is being generated to bring more confidence to this extrapolation.

Justification for classification or non-classification

Repeat toxicity studies are available for a number of substances with the category by both the dermal and oral routes. (Inhalation is not considered relevant due to the very low vapour pressure of TEGEE). Some studies are of higher quality than others since they are more modernFor the oral route, classification is only required if significant toxic effects are seen at a dose of 100mg/kg or lower and 200mg/kg for the dermal route. From the available data from substances within the category applied to TEGEE, it can be concluded with some confidence that TEGEE is not likely to meet these criteria and therefore classification is not required.

The necessity to apply EUH066 for the skin effects seen in the dermal repeat dose studies with some category members should be considered. However, since the effects produced by the substances themselves are not considered sufficient to warrant applying this phrase, it is not considered appropriate to apply it to TEGEE.