Registration Dossier
Registration Dossier
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EC number: 310-288-2 | CAS number: 161907-78-4 A complex mixture of oxygenated hydrocarbons produced by the distillation of residues from the manufacture of ethylene glycol monoethyl ether. It consists predominantly of a mixture of di-, tri-, tetra- and pentaethylene glycol monoethyl ethers having carbon numbers predominantly in the range C6 to C12 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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