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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-090-0 | CAS number: 761-65-9
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The substance is acutely harmful to fish.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- 89.3 mg/L
Additional information
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of the N,N-dibutylformamide (CAS 761-65-9) (Q)SAR results were used for the estimation of the acute toxicity to fish. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
The QSAR result is used to support the experimental key study (Brooke et al., 1984). Further experimental studies are not provided.
Assessment
The experimental data on acute toxicity of the N,N-dibutylformamide to fish are available (Brooke e al., 1984). This flow-through study was conducted according to Standard Methods for the Examination of Water and Wastewater, 15th ed. (APHA). The study was not performed under GLP, but the test procedure is in accordance with generally accepted scientific standards and described in sufficient detail.
Based on available experimental results N,N-dibutylformamide is considered to be acutely harmful to fish. The validity criteria according to OECD TG 203 are fulfilled. The 96 h LC 50 was determined to be 89.3 mg/L (nominal, analytically verified, Brooke et al., 1984)
The experimental result is supported by a LC50 for the short-term toxicity on fish which was determined using the OECD QSAR Toolbox v4.4. The 96-h LC50 for mortality was derived using a trend analysis of the standardized workflow for ecotoxicological endpoints as provided by the Toolbox (BASF SE, 2021). The resulting 96-h LC50 was 64.7 mg/L. The Substance is within the applicability domain of the model. The LC50 is within the same order of magnitude as the experimental data.
As key value, the LC50 from the study by Brooke et al. (1984) will be used as the LC50 was experimentally derived and the study is fully reliable and valid.
Overall, it can be concluded, that based on the available experimental and estimated data the substance is acutely harmful to fish.
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.
