Registration Dossier
Registration Dossier
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EC number: 201-618-5 | CAS number: 85-60-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is not readily biodegradable achieving 2-12% in 28 days. Due to the high water insolubility (<4 μg/l), it is not possible to assess the potential for hydrolysis by testing. The substance is, however a stable organic molecule and is therefore, considered by assessment of structure and experience in use to not hydrolyse in the environment.
The substance is considered to be very persistent in the environment were exposure to occur, based on the known lack of biodegradability.
The bioconcentration factor (BCF) has been calculated as 41 to 758.9 L/kg wet-wt. using QSAR estimation based upon the SMILES code of the molecular structure QSAR model for fish BCF, based on a Radial Basis Function neural network CAESAR v2.1.11 and Arnot-Gobas in EPI Suite.
The partition coefficient was determined to be 6.4. The high log Pow is likely to be due in part to the hydrophobic nature of the molecule.
Furthermore, assessment of the toxicity of the substance shows no dose-related effects at 1000 mg/kg bw/day.
Based on this data the substance is considered to be non-bioaccumulating.
Eco-toxicity studies:
Due to the substance being highly insoluble in water exposure to three aquatic species (algae, daphnia and fish) have been investigated at nominal concentrations. The toxicological examination on fish provided an LC50 >1000 mg/L, on daphnia EC50 >100mg/L and on algae EC50 >100 mg/L.
Mammalian toxicity studies:
The substance has been assessed for genetic toxicity by five in vitro assays with and without metabolic activation, all studies demonstrated a lack of mutagenic response.
The reproduction/developmental screening test produced a NOAEL 1000 mg/kg bw/day with no significant dose-related effects detailed.
The 90-day toxicity feeding study achieved a NOAEL 100ppm.
Considering the toxicological information the substance is not toxic.
The substance may pose a persistence (P) hazard but as the results produced no bioaccumulation (B) or toxicity (T) properties the substance cannot be considered as a PBT / vPvB.
- Likely routes of exposure:
The substance is a powder of a particle size that is not breathable and is generally used in closed conditions.
The likely route of exposure to workers would be by dermal exposure.
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