Registration Dossier
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: 202-607-8 | CAS number: 97-77-8
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Data for the definitive conclusion on the PBT or vPvB properties of disulfiram (CAS No. 97-77-8) are available, except for those regarding the Bioaccumulation (B) criterion. Thus, the screening criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT assessment” (ECHA, 2008) are used as surrogate information to decide whether this substance meets the B criterion and further on, may potentially fulfill the PBT or vPvB criteria.
Persistence (P):
According to the criteria stated in Regulation (EC) 1907/2006, Annex XIII, persistence can be determined through the evaluation of the dissipation half-lives of a substance in different environmental compartments. The biodegradation of disulfiram in water, sediment and soil could be investigated using data from an analogue substance. Hydrolysis (half-lives of 68.5 days, 3.5 days and 6.9 hours at pH 5, 7 and 9) and photolysis (half-life < 10 days) are expected to contribute significantly to the degradation of this substance in water. Disulfiram will be also rapidly degraded in water/sediment and soil systems, in which half-lives below 2 days and 10 days were reported, respectively. Thus, the P criterion is not met for this substance.
Bioaccumulation (B):
Experimental data determining the BioConcentration Factor (BCF) of disulfiram in aquatic organisms are not available. Nevertheless, the log Pow of the substance is considered as a surrogate for the evaluation of the B criterion. According to the screening criteria stated in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT assessment” (ECHA, 2008) substances with log Pow values below 4.5 are not considered as B or vB. Based on this information, disulfiram does not meet the B criterion (log Pow = 3.6).
Toxicity (T):
According to the criteria stated in Regulation (EC) 1907/2006, Annex XIII, the toxicity of a certain substance can be assessed based on the available toxicity data on aquatic organisms and mammals. The long-term study performed testing the chronic effects on fish species (based on data from an analogue substance) resulted in a NOEC value of 4.6 µg a.i./L. Furthermore, this substance is classified as Xn, R48, harmful. Considering this information, the substance meets the T criterion.
Conclusion
The substance is not considered to be PBT or vPvB.
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.
Route: .live1