Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
PBT assessment does not apply
Justification:
  • Persistence

As indicated in the REACH Guidance of PBT assessment, Section C.1.3, page 5 [information_requirements_part_c_en.pdf, dec. 2011], persistency testing is practically not possible due to the refractory inherent properties and complexity of this UVCB substance.

Wording in the REACH Guidance:

"....However, for substances for which persistency testing is difficult or practically impossible, like e.g. for certain multi-constituent or very poorly water soluble substances, it may sometimes be more reasonable to start the PBT/vPvB assessment by evaluating the B criterion (see Section R.11.1.3.2 for further guidance)."

  • Bioaccumulation

Coal-tar pitch is a practically water-insoluble UVCB substance and cannot pass biological membranes due to its complex high-molecular matrix structure. Besides its poor bioavailability, the determination of the partition coefficient is technically not feasible. Hence, the bioaccumulation criteria for PBT are not applicable to pitch itself. This is in line with the assumption that substances of a molecular mass of >700 are considered to be non-accumulating.

Wording in the REACH Guidance, Section C.1.4.2, page 6:

"...However, for a substance produced or imported at a level of 100 t/y or more, information on bioconcentration in aquatic species has to be made available by the registrant and to be considered in the assessment, unless this information can be waived according to column 2 of Annex IX or according to Annex XI(3) (e.g. low bioaccumulation potential, no exposure, testing technically not possible)."

  • Toxicity Assessment

Coal-tar pitch showed no acute and chronic aquatic toxicity under standard experimental conditions. However, CTPHT is classified as CMR substance. The current re-evaluation concludes: Carc. 1A, Muta. 1B and Repr. 1B. Therefore the T criterion is fulfilled.

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NOTE: Case of conflict

The substance “Pitch, coal tar, high-temp. (CAS No. 65996-93-2; CTPHT)” had been subject to the European procedure identifying substances of very high concern (SVHC). On Dec 2, 2009, the Member State Committee adopted that CTPHT is considered as a substance with both PBT and vPvB properties and subsequently placed CTPHT on the REACH Annex XIV candidate list.   Ref.: http://echa.europa.eu/doc/candidate_list/svhc_supdoc_pitch_publication.pdf.

Pitch, coal tar, high temp. (CAS 65996-93-2) was listed on 13 January 2010 as authorisation candidate according to Art. 59(1, 10) of the REACH Regulation No. 1907/2006 after classification as PBT substance.

The legality of the PBT classification is challenged by industry and currently reassessed by the General Court, Luxembourg (Case C-287/13P, follow up to Case T-93/10).

Industry considers that the evaluation has solely been based on the PAH analysis of CTPHT and does not take into account the very low water solubility and stability. The ingredients of this UVCB substance are trapped in a high-molecular matrix.

 

The only constituent of CTPHT classified as PBT substance is anthracene (CAS 120-12-7). The European CTPHT Composite sample No. 8 representing the market average and technical basis for this registration dossier contains 0.06% anthracene.

 

No ingredient of coal tar pitch amounts to more than 10%. Apart from anthracene, all other 15 EPA PAHs are not considered to be bioaccumulating or very bioaccumulating, based on an expertise of CONCAWE (2009) [ Lampi M; Parkerton T 2009: Bioaccumulation Assessment of PAHs.ExxonMobil Biomedical Sciences, Inc., CONCAWE, October 2009].