N,N-diethylhydroxylamine

Endpoint summary

Additional information

In accordance to ECHA's Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7C (v3.0, June 2017, p.146), two long-term studies have been conducted as DEHA falls within the soil hazard category 3 (not readily biodegradable and not very toxic to aquatic life). The performed studies (OECD 222 and OECD 216) are in accordance with those recommended in the above mentioned guidance. The two studies are long-term tests, as stated in both ECHA's Guidance R7c and OECD 216 guideline. A PNEC has been derived using a NOEC of 320 mg/soil dry weight and an assessment factor of 50, in accordance with ECHA's Guidance Chapter R.10 (May 2008). The resulting RCRsoil are far below 1. Therefore, according to column 2 of annex X of REACH regulation EC 1907/2006, no toxicity study on plant is required.

 

This strategy was proposed to ECHA following a final decision on our testing proposal. In its answer, ECHA stated the following: "We have examined the arguments and the approach you bring forward in your letter, and can preliminary conclude that your arguments seem to be plausible and well justified. Therefore we propose that you update your registration dossier by the deadline set in the decision, and revise the chemical safety assessment with the approach and arguments you have presented in your letter with sufficient documentation. Then we will be in a position to evaluate your approach for the revision of the chemical safety assessment as requested in the decision."

ECHA's recommendations were strictly respected. The registrant’s letter and ECHA’s answer are present as attached files in the present section of the IUCLID.