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PBT assessment

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PBT assessment: overall result

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

8.1.1.1.1. Persistence (P) Assessment

The substance is not readily biodegradable in accordance with the definition given in the OECD Guidelines for the Testing of Chemicals. However, the half-life of the substance was determined to be 12 – 13.5 days in freshwater and 10.5 – 71 days in freshwater sediment.

Therefore, the substance does not meet the P criterion and is not considered as persistant (P) or very persistant (vP).

8.1.1.1.2. Bioaccumulation assessment

 

Results of astudy reveal that the does not show significant accumulation in aquatic organisms. Due to rapid depuration, the potential for biomagnification through the food chain is low as indicated by a study according to OECD 305 B and GLP (Bidinotto, 2004). The depuration half-life of the substance in fish ranged from 31 to 35.5 h and its bioconcentration factor (BCF) was found to range from 8.92 to 10.24. Thus, the substance has a low potential for bioaccumulation in fish. The log Kow of the substance with a value of 2.9 is below 4.5.

The available information indicates that the substance has a very low potential for bioconcentration and will not accumulate to significant levels in aquatic organisms.

Therefore, the substance does not meet the B criterion.

8.1.1.1.2. Toxicity assessment

 

From the ecotoxicity perspective the toxicity criterion is met for the substance with a lowest NOEC of 0.01 mg/L (long term fish) being at the ecologically relevant NOEC triggers of 0.01 mg/L.

The substance is classified for specific target organ toxicity after repeated exposure (STOT RE 1) based on the effects on liver and thyroid gland in a subchronic toxicity study with rats. The criteria for toxic (T) based on mammalian effects are therefore met.

 

Therefore, the substance meets the T criterion.

8.1.2. Summary and overall conclusions on PBT or vPvB properties

Overall conclusion:

Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.

Justification:

According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to meet all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to meet all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII. Based on the relevant data provided and discussed, the substance is not identified as PBT or as a vPvB substance.