Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Justification for grouping of substances and read-across

The category covers fatty acid polyesters of polyols (Trimethylolpropane (TMP) or Pentaerythritol (PE)) mixed with adipic acid. The category contains UVCB substances with fatty acid carbon chain lengths from C8-C18 (even-numbered, including linear saturated and unsaturated chains) building mono-, di-,tri- or higher esters with TMP or PE respectively in variable proportions.

The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate, environmental and human health hazards. Thus where applicable, environmental and human health effects are predicted from adequate and reliable read across data within the group applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 5, 6.1. and 13) and within Chapter 7.1 in the CSR.

Endpoint specific data matrix:

ID #

Identifier

Toxicity to soil macroorganisms except arthropods

Toxicity to terrestrial arthropods

Toxicity to terrestrial plants

Toxicity to soil microorganisms

1

CAS 95912-89-3 (a)

Experimental result
NOEC (56d)
  

≥1000 mg/L(nom., reproduction)

waiving

waiving

WoE

2

CAS 91001-61-5

Experimental result
NOEC (56d)
  

≥1000 mg/L(nom., reproduction)

waiving

waiving

WoE

3

EC 921-836-0

RA: CAS 91001-61-5

waiving

waiving

WoE

 (a) Category members subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.

Only for these substances a full set of experimental results and/or read-across is given.

Terrestrial toxicity

The members of the PFAE mixed and branched category are characterised by a high log Koc (> 5), indicating a considerable potential for adsorption to the soil particles. Therefore, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of PFAE mixed and branched category members. As stated in the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance, earthworm testing allows potential uptake vie each of surface contact, soil particle ingestion and pore water (ECHA, 2012). The Guidance also states that in absence of clear indication of selective toxicity, an invertebrate (earthworm or collembolan) is preferred. Therefore, the earthworm was chosen as the most suitable test organism for PFAE mixed and branched category members.The long-term terrestrial toxicity has been tested on the earth-worm Eisenia andrei with the category member Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS-No 95912-89-3) and Fatty acids, C16-18 and C18-unsatd., mixed esters with adipic acid and trimethylolpropane (CAS-No 91001-61-5).

Based on reproduction the 56 -day NOEC was ≥ 1000 mg/kg soil dry weight for both substances.

Since, all PFAE mixed and branched members are expected to have a similar behaviour in the environment based on their physico-chemical properties such as low water solubility (<1 mg/L), high potential for adsorption to soil particles (log Koc >5) and ready biodegradability, the remaining data gap within the category can be confidently covered by the two studies.

Furthermore, based on the physico-chemical properties mentioned above, the low bioaccumulation potential due to the molecular weight (512-1969 g/mol), size and structural complexity of the molecules and no toxic effects on aquatic organisms up to the limit of water solubility the PFAE mixed and branched category members are unlikely to pose a risk for terrestrial organisms in general.

In conclusion, terrestrial toxicity is not expected.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.