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PBT assessment

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PBT assessment: overall result

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Name:
Trihexyl phosphate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Name:
Trihexyl phosphate
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT/vPvB Assessment” (ECHA, Version 3.0, June 2017).

 

Persistency assessment

Two GLP guideline studies according to OECD 301 B are available investigating the ready biodegradability of the substance (CAS 2528-39-4). In both studies the pass level was not reached within 28 days therefore the OECD criteria for being readily biodegradable were not fulfilled.  Since the pass level of one OECD 301B test reached after a prolonged test duration up to 38 days, it can be considered that the substance will fully mineralize under environmental conditions within a short time period and thus persistency in the environment can be excluded. Therefor it can be stated that the substance is not P/vP.

Bioaccumulation assessment

The substance has a log Kow of 7.04 OECD 117 (HPLC method). In accordance with the ECHA Guidance R.11 substances with a log Kow of > 4.5 are considered to be B/vB. Thus, the substance is considered to be potentially B/vB based on the screening criteria.

Toxicity assessment

Acute aquatic studies are available for three trophic levels (EC/LC50 > 0.01 mg/L). Furthermore also a chronic effect value derived from the algae toxicity study was with 0.095 mg/L above the 0.01 mg/L. Moreover, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to the consolidated version of Regulation (EC) No. 1272/2008 and all further amendments (ATPs). Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.