Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro-

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow <=3 and a low potential to cross biological membranes

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
As also described in '2.3 PBT assessment', a weight-of-evidence approach to the assessment of bioaccumulation has been conducted according to the strategy for substances with low octanol and water solubility in the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0).
Step 1: Low water and octanol solubility have been determined experimentally. Octanol solubility was Co=0.103 mg/L and water solubility was Cw=0.0004 mg/L, resulting in log Co/Cw of 2.4, i.e. smaller than 4.5
Step 2: With the substance molecular weight of 357.19 g/Mol, the critical body burden (CBB) was calculated (using equation 11-3) as CBB = 0.002 mMol/L * 357.19 g/Mol = 0.714 mg/L = 714 µg/L, as also reported in Table R.11-14 under 'Diketopyrrolopyrrole Pigment (DPP)'. Therefore, octanol solubility is approx. 6 times smaller than the CBB (equation 11-3).
In addition, the substance does not show a specific mode of action, as it was not toxic in aquatic studies (fish and daphnia short-term studies and a daphnia long-term study). Furthermore, it was not taken up in a rat toxicokinetic study using radiolabelled substance.
Therefore, it can be assumed that the substance has only a limited potential to establish high body burdens and to bioaccumulate.
Step 3: Based on the evidence summarised under Step 1 and Step 2, it can be concluded that the substance is non-B. This is further supported by results of bioaccumulation studies (acc. to OECD 305) with two other DPP pigments. 3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione (EC no. 416-920-6) and 3,6-Bis(4-tert-butylphenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione (EC no. 416-250-2) did not significantly bioaccumualte in fish.

Reason / purpose for cross-reference:

data waiving: supporting information

Description of key information

A weight-of-evidence approach to the assessment of bioaccumulation has been applied according to the strategy for substances with low octanol and water solubility in the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0).

Based on evidence demonstrating that both water (Cw) and octanol (Co) solubility are low, resulting in a log Co/Cw of 2.4 (< 4.5), that Cw is substantially smaller than the critical body burden and that uptake is negibible, it can be concluded that the substance does not bioaccumulate.