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EC number: 304-780-6
CAS number: 94279-36-4
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:
Toxicity to soil macroorganisms except arthropods
Toxicity to terrestrial arthropods
Toxicity to terrestrial plants
Toxicity to soil microorganisms
Experimental result:LC50 (14 d) >1000 mg/kg soil dw
Experimental result:EC50 (17-18 d) >100 mg/kg soil dw (nom.)
RA: CAS 90218-76-1
(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 “--“.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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