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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Phosphoric acid, C11-14 (C13-rich)-isoalkyl mono- and di-esters, partially salted with 1-Propanamine, 3-(tridecyloxy)-, branched
Type of composition:
legal entity composition of the substance
Reference substance:
Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The test item attained 0 % biodegradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301 B. Furthermore, the main amine, ether and phosphate ester functional groups predict that the test item will not readily hydrolyse at environmentally relevant pH and temperature. For these reasons, it is necessary to conclude that the test material may persist in the environment.

Bioaccumulation

The substance is a complex UVCB for which partition coefficient values were determined using the recommended slow stirring method (OECD 123 and EU Method A.23). Weighted average Log Kow results were reported as 4.94 for cationic components and 4.15 for anionic components at a nominal temperature of 25 °C. However, the substance has been shown to be surface active (48.1 mN/m at 20 °C and 990 mg/L) andLog Kow is not a valid descriptor for assessing the bioaccumulation potential(see ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017). The experimentally derived Log Kow values are therefore viewed as estimates and it is considered unlikely that the threshold value of 4.5 above which bioaccumulation is expected will be exceeded by the UVCB as a whole or its constituents.

Toxicity

Based on available evidence, and in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the criteria for classification as a carcinogen (category 1A or 1B), germ cell mutagen (category 1A or 1B) or reproductive toxin (category 1A, 1B or 2). There is also no evidence of chronic toxicity and the substance does not meet the criteria for classification for specific target organ toxicity (STOT RE 1 or STOT RE 2). With respect to the environment, the substance does not meet environmental classification criteria for non-rapidly biodegradable substances for which there are adequate long-term toxicity data available. However, adequate long-term toxicity data are available for one trophic level only (algae) and, in accordance with ECHA Guidance on the Application of the CLP Criteria (Version 5.0; July 2017), the test item has been classified as Aquatic Chronic 2 as a precaution. Present regulatory obligations do not require investigation of long-term exposure to the substance in fish or aquatic invertebrates and it is not possible to definitively conclude not T (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017).

Likely routes of exposure:

Human exposure via the dermal route plus release to the environment via waste water.