Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-337-1 | CAS number: 3069-33-8
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), rat: LD50 = 1000 mg/kg bw (cut-off value)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key study is available with N-[3-(methoxydimethylsilyl)propyl]ethylenediamine (CAS 3069-33-8), which was conducted according to OECD 423 and in compliance with GLP (LPT, 2003). In a first step 3 male Crl:CD rats were treated with the limit dose of 2000 mg/kg bw. Two animals died within 2 days showing reduced motility, ataxia, reduced muscle tone, and dyspnea. In accordance with the testing strategy supplied in OECD guideline 423 3 male animals were treated with 200 mg/kg bw. No mortality and no clinical signs were observed. In a third step 3 female animals were treated with 200 mg/kg bw. Again no mortality and no clinical signs were observed. No findings after necropsy and no effects on body weight were observed in any dose group. A LD50 cut-off value of 1000 mg/kg bw was derived according to the flow chart given in the guideline.
Justification for selection of acute toxicity – oral endpoint
The reliable GLP compliant OECD Guideline study was choosen.
Justification for classification or non-classification
The available data on acute oral toxicity of the test substance meet the criteria for classification as Acute Tox 4“Harmful if swallowed (H302)” according to Regulation (EC) 1272/2008 and as “Harmful if swallowed (R22) according to Directive 67/548/EEC.
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.
