Registration Dossier

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Administrative data

Description of key information

ORAL - RATS (mg/kg): 10600
DERMAL LD50 (mg/kg)
TEGME read across substance: Rabbit: 7.45mg/kg
TEGBE read across substance: Rabbit: 3.45ml/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
10 610 mg/kg bw

Additional information

There is no data available for the UVCB substance itself. There is however measured data for closely related substances either side of it in the homologous series of these triethylene glycol ethers. A full and detailed justification for a read across approach for meeting the individual data requirements for glycol ethers is included as an attachment in chapter 13 to this dossier. For this specific end point, Chapter 13 of the IUCLID dossier submitted by the lead registrant contains a full and detailed justification for using a category approach to fulfil the data requirements for glycol ethers and to specifically justify the use of read across for certain end points, including this one. The analysis included in this document shows there is a clear trend towards reducing toxicity vertically down a homologous series. Interpolation between the results of other glycol ethers within the same homologous family of triethylene glycol ethers can be considered a valid approach to meeting the data requirements of this substance. Data for analogue substances is shown below:

An old but reliable acute oral gavage toxicity study is available for one of the two main components of this UVCB substance 2-(2-(2-ethoxyethoxy)ethoxy)ethanol . In this study, the LD50 was calculated as 10.61g/kg.

In an acute dermal toxicity study in rabbits under occluded conditions with the substance 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol in which key basic details were reported, an LD50 of 7100mg/kg was obtain. In an acute dermal toxicity study under occluded conditions using the substance 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol in rabbits, in which only basic details were reported, an LD50 of 3540mg/kg was obtain. It is reasonable to conclude that the acute LD50 by the dermal route for the substance 2 -(2 -(2 -ethoxyethoxy)ethoxy)ethanol will fall somewhere between these two values.

No acute toxicity data is available by the inhalation route but the very low volatility of this substance and low acute toxicity by other routes leads to the conclusion that such data is not required to conclude that there is no acute toxicity hazard by the inhalation route.

On the basis of a read across extrapolation, it can be concluded with certainty that the substance has very low acute toxicity.

Justification for classification or non-classification

The available data indicates that this substance is of very low acute toxicity by all routes of exposure and classification is not warranted.

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