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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is PBT / vPvB
Justification:

Following a decision of the Executive Director of ECHA, dated 22 December 2009, the substance pitch, coal tar, high temp. (EC No.: 266-028-2, CAS No.: 65996-93-2) is included in the Candidate List of Substances for eventual inclusion in REACH Annex XIV. This decision entered into force on 13 January 2010.

From this date on, pitch, coal tar, high temp. (CTPht) is identified as substance of very high concern based on its carcinogenic and PBT/vPvB properties.

A detailed justification for the identification of pitch, coal tar, high temp. as CMR, PBT, and vPvB substance is presented in the SVHC Support document, prepared by ECHA and dated 2 December 2009 (URL: https://www.echa.europa.eu/documents/10162/73d246d4-8c2a-4150-b656-c15948bf0e77). The summary at the beginning of this document describes the reasons for identification of pitch, coal tar, high temp. as substance of very high concern and is quoted here as justification for the PBT status of pitch, coal tar, high temp.

 

Start of the excerpt from the SVHC support document

 

Summary of how the substance (pitch, coal tar, high temp.) meets the CMR (Cat 1 or 2), PBT or vPvB criteria, or is considered to be a substance giving rise to an equivalent level of concern

 

The PBT assessment of CTPht focused on the assessment of its PAH-constituents having been identified in concentrations above or equal to 0.1 % (indicator PAH-constituents). For 10 of these 12 indicator PAH-constituents assessed in total, half-lives in soil have been reported to be in the range of 5.7 to 9.1 years under field conditions. As these half-lives observed in soil exceed the P and vP-criteria (half-lives of 120, respectively 180 days), it is concluded that the vP criterion is fulfilled by all 10 PAH-constituents. Experimentally obtained BCF values higher than 5,000 are reported in fish, mollusks, or crustaceans for 9 indicator PAH-constituents of CTPht. As these BCF values exceed the B- and vB criteria (measured BCF values in aquatic species > 2000, respectively > 5000), it is concluded that the vB-criterion is fulfilled by the respective 9 substances. BCF values > 2000 have been reported for anthracene, which is a further indicator PAH-constituent of CTPht and thus fulfils the B-criterion. Long-term data for marine or freshwater species showing no effect concentrations (NOEC/EC10) < 0.01 mg/l are available for 9 of the indicator PAH constituents of CTPht. Furthermore, 6 of the indicator PAHs found in CTPht are classified as carcinogen, mutagen or as toxic to reproduction in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). Based on the available experimental aquatic toxicity data and the data on classification, it is concluded that 11 of the 12 indicator PAH-constituents for the assessment of CTPht fulfil the T-criteria of Annex XIII of the REACH Regulation.

 

On the basis of the available data, it is concluded that 7 of the 12 indicator PAH-constituents identified in CTPht in concentrations equal to or above 0.1 % are to be considered as both vPvB and PBT substances (fluoranthene, pyrene, benz[a]anthracene, chrysene, benzo[a]pyrene, benzo[k]fluoranthene, and benzo[ghi]perylene), one (phenanthrene) as vPvB, and one (anthracene) as PBT. For coal tar pitch, high temperature (CTPht), the above conclusion on the PBT/vPvB properties of its indicator PAH-constituents has the consequence that this substance needs as well be considered as a substance meeting both the criteria of Article 57(d) and of Article 57(e) of the REACH Regulation.

 

As, in addition, CTPht is classified as carcinogen (Carc. Cat.2; R45) (May cause cancer) according to Annex VI, part 3, Table 3.2 (the list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008*, CTPht is as well a substance meeting the criteria of Article 57 (a) of the REACH Regulation.

 

End of the excerpt

 

* Corrigendum: Current classification of pitch, coal tar, high temp. is Carc. 1A (H350), Muta. 1B (H340), and Repr. 1B (H360FD) according to Commission delegated Regulation (EU) 2020/217 of 4 October 2019 amending Regulation (EC) No 1272/2008 (CLP Regulation).