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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

PBT and vBvP Assessment of the main component

A substance is identified as a PBT substance if it fulfils all criteria described in REACH Annex XIII. According to information summarized in the sections 4 to 7, 7PPD fulfils the T criterion and does not fulfil the P or B criteria. Hence 7PPD is not PBT.

A substance is identified as a vPvB substance if it fulfils both the vP and the vB criteria as described in REACH Annex XIII.

Neither the vP criterion nor the vB criterion is fulfilled. Therefore, 7PPD is not vPvB.

PBT and vBvP Assessment of transformation products

In the hydrolyis study several hydrolysis products have been found: 4 - Hydroxydiphenylamine, its oxidised form 4-(phenylnitroso)benzen-1-olate ("N-Oxide"), Aniline p-Hydroquinone, 2,4 -Dimethylpentylamine and p-Benzoquinone and additionally the oxidesed form of 7PPD (7QDI) as a metabolite in the anaerobic soil simulation study which were individually assessed for PBT/vPvB properties. These metabolites are also considered as not PBT and not vPvB.

PBT and vBvP Assessment of Impurities >0.1%:

According to the REACh regulation, also impurities >0.1% are subject to PBT and vBvP assessment. The relevant impurities are listed inTable3. Chemical structures can be found in IUCLID chapter 1.2.

 

  • N,N'-di-sec-butyl-p-phenylenediamine(EC no.: 202-992-2) (common name 44PD) andN,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine(EC no.: 221-375-9) (common name 77PD) are impurities which are members of the PPD family. Their characteristics have been used for the read-across approach. The relevant parameters are described in the read-across justification document attached to the IUCLID file chapter 13. Their properties, especially the mode of hydrolysis, are similar to those of 7PPD and thus, these substances are evaluated in the same way as 7PPD is. Hence, these impurities are not PBT or vBvP.
  • N-(4-aminophenyl)aniline(EC no.: 202-951-9) (common name 4-ADPA) is a substance which is already listed in the ECHA dissemination tool. The substance is not readily biodegradable but inherently biodegradable with more than 70% DOC removal in 7 days independent from adsorption. The calculated BCF is 7. The most sensitive long-term effect concentration was observed in a daphnia reproduction test with a 21d-NOEC of 0.04 mg/L. Hence, the substance is neither PBT nor vBvP.
  • N,N-di(1,4-dimethylpentyl)aminecan be considered as dimeric form of 1,4-dimethylpentyl- amine, which is the primary degradation product of 7PPD. The properties or this substance has been already discussed in chapter 8.1.1 and is evaluated neither to be PBT nor vBvP.
  • Mono alkylated aniline from aniline and N-(1,4-dimethylpentyl)-benzeneamine: According to information from 7PPD, just the hydrolysis behavior should be similar. Primary hydrolysis products are aniline and 1,4-dimethylpentylamine. The properties or these substances have been already discussed in chapter 8.1.1. Both substances are evaluated to be not PBT and not vBvP.
  • There are indications that further impurities may exceed the 0.1% level. Although the identity of each individual impurity has not been eleucidated in the analytical method used for the characterization of the substance, older analytical studies indicate that these unknown impurities are likely to have PPD-like structures. Therefore they will behave (hydrolyse etc.) in a similar manner.