Registration Dossier

Administrative data

Description of key information

Study

Result

Comment

TEGBE

21 day dermal repeat dose study in rabbits

[NOAEL (local irritation): <1000mg/kgbw/day]

NOAEL (all other effects): >1000mg/kgbw/day - no adverse effects at maximum tested dose

 

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

Predictions are based on a weighted average consideration of the results for this substance and other substances within the category.  Results corrected for molecular weight differences. There is no data on the repeat dose  toxicity of this substance from studies to modern guidelines. A sub-acute bridging study is being carried out on this substance to add confidence to bridging between members of this category.

 

Justification for classification or non-classification

Repeat toxicity studies are available for all three source substances by both the dermal and oral routes. (Inhalation is not considered relevant due to the very low vapour pressure of TEGME). For 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 it can be concluded with some confidence that TEGBE 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 should be considered. However, since the effects produced by the source substances are not considered sufficient to warrant applying this phrase, it is not considered appropriate to apply it to TEGBE.