Registration Dossier
Registration Dossier
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EC number: 500-537-5 | CAS number: 161075-00-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence
GALDEN LMW is considered very persistent due to its chemical structure which is stable in respect to abiotic and biotic degradation.
According to its environmental fate the main compartment of distribution is the atmosphere in which the lifetime has been estimated to be around 800 years (Young et al., 2006)
Bioaccumulation
Due to the low water solubility and high tendency to volatilization of GALDEN LMW, the standard bioaccumulation study on aquatic organisms through water exposure is not feasible. Additionally, GALDEN LMW is not expected to bioaccumulate in aquatic species, as due to its high Henry constant and low water solubility, GALDEN LMW has the strong tendency to volatilize from the aqueous phase. Furthermore, there is no direct or indirect exposure of GALDEN LMW to the aquatic environment during the manufacturing process or the identified uses. Therefore, the water compartment is not considered as a relevant compartment for bioaccumulation potential (neither the water column, nor the sediment part).
However, in accordance with its high tendency to partition into the air compartment, bioaccumulation in air-breathing organisms is to be addressed. The Octanol/Air partition coefficient (KOA) is recognized as a parameter that can serve as a screening criterium for bioaccumulation in air-breathing (terrestrial) organisms. The log Koa of GALDEN LMW has been measured and found to be 0.8670 (at T 20°C). This result indicates that GALDEN LMW is not expected to bioaccumulate in air-breathing organisms.
In conclusion, in accordance with the recommendation of the JRC report "Review of available criteria for non-aquatic organisms within PBT/vPvB frameworks" (Part I bioaccumulation assessment), 2014, GALDEN LMW is not considered as having potential for bioaccumulation, neither for the aquatic organisms because there would not be any exposure in the aquatic compartment, nor for air-breathing organisms due to low octanol/air partition coefficient.
Toxicity
The substance is not considered to be toxic according to the criteria based on Annex XIII of REACH.
Moreover, under all the available toxicity studies no signs of systemic toxicity have been observed for GALDEN LMW indicating that systemic absorption following inhalation, oral and dermal administration may be negligible (No ADME studies are available for GALDEN LMW).- Likely routes of exposure:
Because of its physical and chemical properties the main route of exposure to GALDEN LMW is by inhalation.
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