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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

1.PBT AND VPVB ASSESSMENT

1.1.Assessment of PBT/vPvB Properties

1.1.1.Summary and overall conclusions on PBT or vPvB properties

The substance sodium methanolate does not fulfil the screening criteria for persistence, bioaccumulation and toxicity. In conclusion, sodium methanolate is not a candidate for PBT or vPvB classification.

 

1.1.2.PBT/vPvB criteria and justification

Data for the definitive conclusion on the PBT or vPvB properties of sodium methanolate are not available. 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 the substance may potentially fulfil the PBT or vPvB criteria.

Persistence

The screening criterion for persistence is the potential of a substance for degradation. The substance sodium methanolate reacts readily with waterto form sodium hydroxide and methanol. Methanol is readily biodegradable whereas sodium hydroxide as an inorganic substance is no subject to biodegradation. In addition, methanol, evaporates readily. Photodegradation of methanol takes place with a half-life of 17-18 days. Hence, sodium methanolate does not fulfil the criteria for persistence.

Bioaccumulation

A test on bioconcentration in aquatic organisms is not needed due to the very low potential of sodium methanolate for bioaccumulation. Available experimentally observed BCF values for methanol were observed as <10 L/kg.

According to “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT assessment” (ECHA 2008), the screening criterion for bioaccumulative substances which has to be classified as “B” or “vB”, is a BCF > 2000 L/kg. As the BCF for the surrogate sodium methanolate is well below this trigger, the substance is not considered to have bioaccumulative properties in the frame of a PBT assessment.

Toxicity

The screening for the “T” in support of the PBT assessment is based on acute toxicity tests with aquatic organisms. Low toxicity was observed in all organisms with LC50 values >100 mg/L for all endpoints (with methanol).

Further, in an early-life-stage bioassay conducted withOryzias latipesavailable by Gonzales-Doncel et al. (2008) NOECs for methanol range between 7900 - 15800 mg/L. This result indicates that methanol has a very low long-term toxicity to fish.

Since the endpoint of methanol is well above the trigger of 0.01 mg/L, sodium methanolate is not classified as toxic (“T”) related to the environment.

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, sodium methanolate does not meet the T criterion.

 

1.2.Emission Characterisation

Emission characterisation is not required since sodium methanolate does not fulfil the PBT / vPvB criteria.