Registration Dossier
Registration Dossier
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EC number: 906-484-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
According to ECHA factsheet of 15/09/2009 ECHA considers registration dossiers for substances ≥ 1000 t/y as technically complete even if they do not contain the results of a screening study for reproductive/-developmental toxicity if the following condition is met: The dossier contains either the results of, or a testing proposal for, a prenatal developmental toxicity study and either the results of, or a testing proposal for, a 2-generation reproductive toxicity study. Testing proposals for a prenatal developmental toxicity study and for a 2-generation reproductive toxicity study were created in IUCLID sections 7.8.2 and 7.8.3.
DIPE as a main components of the reaction mass of DIPE and 2 -methylpent-2 -ene was not found to be toxic for reproduction based on literature data (1; see table below). Furthermore, C6 -branched olefins as analogue for 2 -methylpent-2 -ene and its isomers were not found to be toxic for reproduction (2, see table below).
For a detailed study proposal see attachment.
Table: Reproduction toxicity data for the main components of the reaction mass from literature
|
Oral |
Inhalation |
Conclusion |
DIPE (1) |
|
NOAEL: 430 ppm (maternal and developmental toxicity) (rat, 20 days) |
DIPE is not a teratogen |
| 2 -methylpent-2 -ene (2) | The NOAELs for reproductive and developmental effects were >1000 mg/kg/day (for analogue, C6 -branched olefins) | Based on evidence from reproductive/developmental toxicity screens in rats with C6 linear/branched internal olefins, along with the findings of no biologically significant effects on male or female reproductive organs in repeated dose toxicity studies, the category members are not expected to cause reproductive or developmental toxicity (for analogue, C6 -branched olefins). |
References:
(1) ExxonMobil Chemical Company Shell Chemical LP For: American Chemistry Council, lsopropanol Panel, Diisopropyl Ether HPV Task Group December 12,2005
(2) OECD SIDS: Higher Olefins-Category, SIDS Initial Assessment Report For SIAM19; Berlin, Germany, 19-21 October 2004, prepared by the American Chemistry Council, Higher Olefins Panel
Justification for classification or non-classification
Based on the available data of the constituents, the reaction mass is not classified as toxic to reproduction. This will be verified with the proposed tests.
Additional information
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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