Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistent:

Methylenebis (dibutyldithiocarbamate ) is considered not readily biodegradable in the environment attaining 21% degradation in 28 days, however Methylenebis (dibutyldithiocarbamate ) is considered as inherently biodegradable and the substance is expected to potentially degrade above 60% after 40 days and ultimately fully biodegrade.

According to Annex XIII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Methylenebis (dibutyldithiocarbamate) does not meet the screening criterion for Persistence (P).

Bioaccumulation:

Based on the low water solubility (0.247 mg/l at 20 ± 5 ºC) and high Log Pow (8.42 at 35 ºC), Methylenebis (dibutyldithiocarbamate) is not expected to be absorbed via the oral route.

In addition using the Estimation Programs Interface (EPI) SuiteTM was developed by the US Environmental Protection Agency's Office of Pollution Prevention and Toxics and Syracuse Research Corporation (SRC), the BCF was calculated at 6.082. According to Annex XIII, 1.1.2 Bioaccumulation, a substance fulfils the bioaccumulation criterionn (B) when the bioaccumulcation factor is higher than 2,000.

According to Annex XIII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Methylenebis (dibutyldithiocarbamate) does not meet the criterion for Bioaccumulation (B).

Toxicity:

Based upon the long term NOEC toDaphia magna(0.247 mg/l) and the lack of classification for reproductive toxicity and repeated dose toxicity, according to Annex XIII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Methylenebis (dibutyldithiocarbamate) does not meet the criterion for environmental toxicity (T).