Registration Dossier

Classification & Labelling & PBT assessment

DSD-DPD

General information

Not classified
Status:
67/548/EEC self classification
Remarks:
Rationale for testing the substance as aqueous solution The testing laboratory got the substance as an aqueous solution. The testing of the product in pure form is not practicable for the reasons set out below: The product is obtained in the form of an aqueous solution containing active ingredient and sodium chloride. The manufacturing at higher contents of solids is not possible, because otherwise the solubility of the reactant sodium monochloroacetate is exceeded and no complete conversion to the registration substance is achieved. The following attempts were made in the laboratory to isolate the substance from the aqueous solution: To purify the product (partial desalination) the water was distilled in vacuum at elevated temperature. The substance was present as a highly viscous liquid, which solidified on cooling to a tough, glassy mass. Therefore, the product was dissolved in ethanol at elevated temperature. During cooling in refrigerator sodium chloride crystallized and could be separated by filtration. By this, sodium chloride content can be reduced to 9% of the solids content. The ethanol was distilled under vacuum at elevated temperature, and the product was left as highly viscous liquid. The product in this form (91% active, 9% sodium chloride) solidified at room temperature to a tough, glass-like mass that could not be handled (poured, weighed, crushed, ...) or brought back into solution. An application or processing in this form is not possible. In addition, this substance is highly hygroscopic. For this reason, the hot substance was diluted with water thus converted into an easily manageable, liquid form. At higher solids content, the solution changes during time (formation of precipitates, turbidity) and by this a uniform composition over time cannot be guaranteed. Conclusion Thus the physical form oft the substance submitted for testing (aqueous solution) is the highest technically feasible active ingredient content concentration. It contains additional substances as water and sodium chloride. The concentration oft commercially marketed products, now and in future, for the reasons given above, doesn’t exceed this concentration.

Classification

Explosiveness

Reason for no classification:
conclusive but not sufficient for classification

Oxidising properties

Reason for no classification:
conclusive but not sufficient for classification

Flammability

Reason for no classification:
conclusive but not sufficient for classification

Thermal stability

Reason for no classification:
conclusive but not sufficient for classification

Acute toxicity

Reason for no classification:
conclusive but not sufficient for classification

Acute toxicity - irreversible damage after single exposure

Reason for no classification:
conclusive but not sufficient for classification

Repeated dose toxicity

Reason for no classification:
conclusive but not sufficient for classification

Irritation / corrosion

Reason for no classification:
conclusive but not sufficient for classification

Sensitisation

Reason for no classification:
conclusive but not sufficient for classification

Carcinogenicity

Reason for no classification:
data lacking

Mutagenicity - genetic toxicity

Reason for no classification:
conclusive but not sufficient for classification

Toxicity to reproduction - fertility

Reason for no classification:
conclusive but not sufficient for classification

Toxicity to reproduction - development

Reason for no classification:
conclusive but not sufficient for classification

Toxicity to reproduction - breastfed babies

Reason for no classification:
data lacking

Environment

Reason for no classification:
conclusive but not sufficient for classification

Labelling

Specific concentration limits

Notes