Registration Dossier
Registration Dossier
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EC number: 906-484-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
According to ECHA factsheet of 15/09/2009 ECHA considers registration dossiers for substances ≥ 100 t/y and 1000 t/y as technically complete even if they do not contain the results of a 28-day repeated dose toxicity study if the following condition is met: The dossier contains a testing proposal for a 90-day repeated dose toxicity study in accordance with Section 8.6.2 of column 1, Annex IX. A Testing proposal for a inhalative 90-day repeated-dose toxicity study was created in section 7.5.3 (IUCLID). In accordance with Annex VIII, section 8.6.1, column 2 and Annex IX, section 8.6.1, column 1, no testing of oral or dermal repeated dose toxicity is required as inhalation is the most probable exposure pathway.
DIPE did not meet the criteria for a classification as Category 1 or 2 Specific Target Organ Toxicity - repeated exposure, or T, R48, as derived from literature values for oral / inhalation repeated dose toxicity, as far as values are known (see table below; NOAEL (oral) > 100 mg/kg b.w./day; NOAEL (inhalation) > 250 ppmV/6h/day or 1 mg/litre/6h/day). C6 internal branched olefins as an analogue for 2 -methylpent-2 -ene and its isomers were also not classified for Specific Target Organ Toxicity toxicity - repeated exposure. (see table below). Hence, it is likely that also the reaction mass will not have to be classified.
Table: Repeated-dose toxicity data for the main components of the reaction mass from the literature
|
Oral |
Inhalation |
Observations |
DIPE (1) |
|
NOAEL: 480 ppm (rat, 90-day) NOAEC 13800 mg/m³, LOAEC: 7100 ppm (rat, subchronic, 13 weeks, exposure 6 h/day) |
|
| 2 -methylpent-2 -ene (2) | NOEL ≥ 100 mg/kg (for analogue C6 internal branched olefins) | NOEL ≥ 3.44 mg/L (1000 ppm) (for analogue C6 internal branched olefins) | In males, alterations in organ weights, changes in certain clinical chemistry/hematology values, and male rat-specific kidney damage that is likely associated with the alpha 20- globulin protein were noted (LOELs ≥ 100 mg/kg oral only). Based on evidence from neurotoxicity screens included in repeated dose studies with C6 internal linear/branched olefins, the category members are not neurotoxic (for analogue C6 internal branched olefins). |
References:
(1) ExxonMobil Chemical Company Shell Chemical LP For: American Chemistry Council, lsopropanol Panel, Diisopropyl Ether HPV Task GroupDecember 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
Currently, the reaction mass is not classified for Specific Target Organ Toxicity based on information available for individual constituents. Classification will be verified by tests with the reaction mass itself.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
