Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

8.1.1. Persistence Assessment

According to Annex XIII of the REACH Regulation (1907/2006/EC), a substance meets the persistence criterion (P) when:

- the half-life in marine water is higher than 60 days, or

- the half-life in fresh- or estuarine water is higher than 40 days, or

- the half-life in marine sediment is higher than 180 days, or

- the half-life in fresh- or estuarine water sediment is higher than 120 days, or

- the half-life in soil is higher than 120 days.

According to Annex XIII of the REACH Regulation (1907/2006/EC), a substance meets the very persistence criterion (vP) when:

- the half-life in marine, fresh- or estuarine water is higher than 60 days, or

- the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or

- the half-life in soil is higher than 180.

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (viaphotolysis, hydrolysis and/or biodegradation).

APD does meet the criteria for ready biodegradability according to the study conducted using method 301F, indicating rapid biodegradation. Therefore, APD does not meet the Persistent (P) or very Persistent (vP) criteria

 

8.1.2.Bioaccumulation Assessment

According to Annex XIII of the REACH Regulation (1907/2006/EC), a substance meets the bioaccumulation criterion (B) when:

- the bioconcentration factor (BCF) is higher than 2000.

According to Annex XIII of the REACH Regulation (1907/2006/EC), a substance meets the very bioaccumulative criterion (vB) when:

- the bioconcentration factor is higher than 5000.

 

Since the log Kow value of AEPD (-1.02) is below 4.5 the substance is not expected to be bioaccumulative,based on the screening criteria for bioaccumulation, stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008).

 

8.1.3. Toxicity Assessment

According to Annex XIII of the REACH Regulation (1907/2006/EC), a substance meets the toxicity criterion (T) when:

- the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is lower than 0.01 mg/L, or

- the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or

- there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Environmental Toxicity:

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L. The lowest NOEC obtained for AEPD was 3.99 mg/L. Thus, AEPD is not considered as a toxic substance regarding ecotoxicological endpoints.

 

Human Health Hazards Assessment:

APD is not classified as carcinogenic, mutagenic or toxic for reproduction, nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) 1272/2008.

 

Thus, APD is not considered to be toxic, based on the available data on ecotoxicological and toxicological endpoints, and therefore the substance does not meet the toxicity criterion (T).

 

8.1.4. Summary and overall conclusions on PBT or vPvB properties

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.

APD is not identified as a PBT nor as a vPvB substance on the basis of the relevant data provided and discussed.