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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-529-2 | CAS number: 2173-57-1
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity information, NOAEL 100 mg/kg bw in an OECD TG 407 study (SIDS dossier)
Key value for chemical safety assessment
Additional information
The need for C&L for systemic Target Organ Toxicity (STOT) classification is discussed because in a the repeated dose toxicity test severe effects are seen at 500 mg/kg bw but not at 100 mg/kg bw (as presented in the SIDS dossier*). The CLP criteria indicate that such C&L need to be considered when severe effects are seen in a specific target organ at =< 300 mg/kg bw in a 28-day study. Severe effects are considered to be those effects that cause dysfunction of a specific target organ or system.
After reviewing the results it is concluded that the substance does not need STOT C&L for repeated dose because at 100 mg/kg bw no adverse effects are seen and at 300 mg/kg bw no severe effects are seen in the 14-day range finder. The dose at which severe effects are seen, 500 mg/kg bw, exceed the EU-CLP criteria (1272/2008 and its amendments).
OECD report (SIAR and SIDS) available:http://webnet.oecd.org/Hpv/UI/SIDS_Details.aspx?id=C660A3E5-4586-4C20-9F34-104F18CF4C79
Justification for classification or non-classification
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.
