Registration Dossier
Registration Dossier
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EC number: 940-417-3 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Overall assessment on the genotoxicity of the registration substance
Four in-vitro studies are avaiable for the assessment of the genotoxicity of the registration substance. One Amest test on the registration substance and three tests (Ames test, chomosome aberration test and HPRT) on the read-across supporting substance. In all four studies no mutagenicity or no clastogenicity was found. The genotoxicity potential of the registration substance is considered to be of no concern.
Justification for the use of diethylenglycoldibutylether (DEGDBE) as read-across supporting substance
DEGDBE belongs to the homologues of butyl-O-(CH2CH2O)n-butyl with n =2, whereas the main components of the registration substance (PolyEGDBE) correspond to the homologues with n = 2,3,4.
Read-across supporting substance |
Diethylene glycol dibutyl ether (DEGDBE)** CAS 112-73-2 |
Butyl-O- (CH2CH2-O)2-Butyl |
Registration substance (Target chemical) |
Polyethylene glycol dibutyl ether (PolyEGDBE)*** CAS 31885-97-9 |
Butyl-O- (CH2CH2-O-)n-Butyl n = 2,3,4 |
The only difference for the registration substance and DEGDBE being the number of ethylenglycol unit in the center of the molecule, the basic concept of "chain length category" can be applied. A comparable toxicity profile is expected.
In addition, the available data for the endpoint repeated dose toxicity are strongly supporting the proposed approach, in that the both substances induced hemolysis and liver effect (OECD 422 study on the registration substance, 28 -day toxicity study on DEGDBE; both studies provided in corresponding endpoint study records), whereas DEGDBE was found to be more potent than the registration substance.
Taking account that DEGDBE is of lower molecular size than the registration substance and that DEGDBE is of less potency than the registration substance after prolonged oral exposure, the registration substance is not likely to exhibit enhanced toxicity than DEGDBE.
In conclusion, the data of DEGDBE can be soundly used for the hazard assessment of the registration substance.
Justification for selection of genetic toxicity endpoint
Four in-vitro tests are available (two Ames test, Chromosome aberration test, HPRT; one Ames test on the registration substance and other tests on the read-across supporting substance). These studies are considered to be of equal validity.
Short description of key information:
No genotoxicity found in in-vitro tests.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification is derived based on the in-vitro data on the registration substance and on the read-across supporting substance.
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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