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PBT assessment

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PBT assessment: overall result

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

According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB. 

The PBT Assessment for Soaps, stocks, acidulated (CAS No. 68607-87-4) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

 

Persistence (P) Assessment:

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. The majority of the constituents of soaps, stocks, acidulated that (CAS: 68607-87-4) are readily biodegradable in one study according to OECD 301 B (> 80% (CO2 evolution) after 28 d). Therefore, it is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

An evaluation of the bioaccumulation potential of Soaps, stocks, acidulated (CAS No. 68607-87-4) is presented in chapter 5.3 (all the constituents of this substance that we register in the ECHA, are considered not to be PBT or vPvB) indicating that bioaccumulation is expected to be low. Based on the above information, Soaps, stocks, acidulated (CAS No. 68607-87-4) does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity Assessment

The screening criterion for toxicity is based on short-term aquatic toxicity studies.Aquatic organisms (algae, daphnia, and fish) did not show any toxicity up to the limit of the water solubility (< 0.05 mg/L). Hence, the substance will not be classified as “T” substance.

In addition, the substance 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) No 1272/2008. Therefore, the substance does not meet the “T” criterion.

 

In conclusion, Fatty Soaps, stocks, acidulated (CAS No. 68607-87-4) is considered not to be PBT or vPvB.