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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Conclusion on Persistance: not vP and not P

In a Ready Biodegradability Test according to OECD Guideline 301 D, EU-Method C.4-E and EPA OPPTS 835.3110, the test item reached a biodegradation rate of 85.7 % biodegradation (based on its ThODNH4) on day 28. The 10-day window criterion for ready biodegradation was unequivocally fulfilled as more than 60 % biodegradation of the test item (78.3 %, based on its ThODNH4) was observed on the fifth day of the test. (see IUCLID section 5.2.1). Therefore, the test item is regarded to be in the 10-d-window and after 28 days readily biodegradable. Consequently, the substance is not considered to be persistent (P) or very persistent (vP).

Conclusion on Bioaccumulation: not vB and not B

In a study according to OECD TG 107 and EU Method A.8 the log Pow of the test item was determined to be -2.8 at 20 °C (see IUCLID section 4.7). This result is below the threshold value for bioaccumulative potential of log Pow > 4.5 as cited in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (Version 3.0, June 2017). Thus, the substance is not considered to be very bioaccumulative (vB) or bioaccumulative (B).

Conclusion on Toxicity: not T

The criterion for toxicity is not fulfilled, since the EC10 for aquatic organisms is >= 0.01 mg/L (the 72-h EC10 (growth rate) for Raphidocelis subcapitata was determined to be > 100 mg/L; see IUCLID section 6.1.5); and the substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A,1C,or 2) according to Regulation EC No 1272/2008; and there is no evidence of chronic toxicity as identified by the substance meeting the critaria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation 1272/2008.

Overall conclusion on PBT and vPvB

Based on the available information, the substance is not PBT / vPvB according to Regulation (EC) 1907/2006.