Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Justification for grouping of substances and read-across

The Polyfunctional acid ester (PFAE) aromatic category covers fatty alcohol esters of Benzene-1,2,4-tricarboxylic acid. The category contains both mono constituent and UVCB substances with fatty alcohol carbon chain lengths from C8-C13 (linear and iso-alcohols) building tri-esters with Benzene-1,2,4-tricarboxylic acid in variable proportions. A further surrogate substance of similar structure is included, namely a triester of Benzene-1,2,4-tricarboxylic acid with a C8 alcohol, but the alcohol moiety is branched (2-ethylhexyl).

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 data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.

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

 

Endpoint specific data matrix:

ID

CAS

Toxicity to soil macroorganisms except arthropods

Toxicity to terrestrial arthropods

Toxicity to terrestrial plants

Toxicity to soil microorganisms

#2

90218-76-1

Experimental result:
LC50 (14 d) >1000 mg/kg soil dw

(nom.)

--

Experimental result:
EC50 (17-18 d) >100 mg/kg soil dw (nom.)

--

#4

94279-36-4 (a)

RA: CAS 90218-76-1

W

RA: CAS 90218-76-1

W

#5

72361-35-4

RA: CAS 90218-76-1

W

RA: CAS 90218-76-1

W

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

(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

 

Terrestrial toxicity

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the terrestrial toxicity of the PFAE aromatic category members is considered to be negligible based on the results from available acute studies with earthworm and terrestrial plants.

The terrestrial toxicity of the PFAE aromatic category has been tested on the earthworm Eisenia fetida with the category member 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CAS No. 90218-76-1). No mortality was observed during the 14-day exposure period at the test concentration of 1,000 mg/kg soil dw. Additionally, data is also available from a test with terrestrial plants for the same substance. The 17-day EC50 value was > 100 mg/kg for all plants tested. All category members are structurally similar and read-across was performed to the structurally most similar category member. The read across is justified due to a) the structural similarity of the category members and b) similar physico-chemical properties (poorly soluble in water (< 0.05 mg/L), high adsorption potential (Koc > 5), high log Kow (> 10) resulting in a similar environmental fate and ecotoxicity profile. There is no convincing evidence that any one of the category members might lie out of the overall profile of this category.

Based on this information, toxicity of the PFAE aromatic category members to terrestrial organisms is not expected to be of concern, and consequently, no further testing is proposed.