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PBT assessment

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PBT assessment: overall result

Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
Composition 0
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB

An evaluation of the inherent properties of T003422 is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a OECD 301B study (Desmares-Koopmans, 2016). The substance is considered to be not readily biodegradable, no significant biodegradation was observed (1% under the conditions of the test). However T003422 showed hydrolysis in an OECD 111 study (Ciric, 2017). The hydrolysis test at 20°C was performed twice due to a possible combination of photolysis and hydrolysis. The DT50 values (days) of the test item at 20° were 1.9, 6.7 and 2.9 at pH 4, 7, and 9 respectively. Hydrolysis is a key feature in the fate of this substance. The low level of biodegradation observed in a modified Sturm test may be misleading since the test used a concentration higher than the expected water solubility of the test substance and so most of the added substance would most likely not be available for biodegradation (the test item tended to float on the water surface). The related substance T003422 is likely to be classified as unstable. In conclusion T003422 should be considered as not persistent.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The log n-octanol/water partition coefficient (Kow) of the test substance in a guideline study (Ciric, 2017) was determined to be greater than 7.2. The substance has a high measured log Kow which may indicate high bioaccumulation. However due to the fact that the compound is unstable as observed in the hydrolysis study, the actual measurement of the log Kow may not be very reliable and bioaccumulation is expected to be low. Furthermore, the utility of a partition coefficient in determining the bioaccumulation potential of hydrolytically unstable substances is questionable. No full bioaccumulation test with T003422 is available however it is expected that the hydrolysis product has no or a low bioaccumulation potential. Due to the fast hydrolysis, exposure of the environment to the substance is unlikely or very low. Considering the above together with the fast hydrolysis of T003422, the potential for significant bioaccumulation is considered low. However, a conservative approach was followed and the substance has been classified as potentially B/vB.

The available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. The acute ecotoxicity testing were performed using test concentration above the water solubility of the test substance. No toxic effects were observed at the highest test concentration. As the substance hydrolysis rapidly and on the basis of the reported data, the screening T criterion is not met. Taking into account the available data and the criteria of the CLP regulation (REGULATION (EC) N° 1272/2008), the substance does not fulfill the screening criterium for being considered as T.

The substance does not meet the P or vP criteria. Bioaccumulation potential is expected to be low due to hydrolysis, however, a conservative approach was followed and the substance has been classified as potentially B/vB. The substance does not meet the T criteria. To conclude, T003422 is not considered a PBT or a vPvB substance according to the EU criteria.