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EC number: 284-895-5
CAS number: 84989-06-0
The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
Waiving according to outcome of risk assessment and the Integrated
Testing Strategy for toxicity to sediment (ECHA, 2017; Endpoint specific
guidance, Chapter R.7c, Section 7.11.6).
In accordance with Regulation (EC) No
1907/2006, Column 2 of Annex IX, section 9.4, toxicity tests on soil
organisms do not need to be conducted if the outcome of the chemical
safety assessment shows no indication of risk on soil organisms from
exposure to the substance in question. The PNEC soil is derived to be
0.096 mg/kg dw from a test with terrestrial plants using an assessment
factor of 1000, since no further data on other trophic levels are
available. Additionally a PNEC soil was derived using the equilibrium
partitioning method on the basis of available data for xylenol-isomers
as they are the main constituents of Tar acids, Xylenol fraction (CAS
84989-06-0). This PNEC soil based on EPM resulted in 0.3093 mg/kg dw.
Since the latter calculated value is less sensitive than the one based
on measured data, derivation of the RCRs is based on the PNEC soil of
0.096 mg/kg soil dw. The risk assessment performed showed no indications
of risks as all RCRs are below 1. Taking all the available information
mentioned above into account no further testing with terrestrial
organisms is required.
Although only data on plants are available
the above approach is further corroborated by the “Guidance on
information requirements and chemical safety assessment Chapter R.7c:
Endpoint specific guidance”, Section 7.11.6, Integrated testing strategy
(ITS) for Effects on Terrestrial Organisms (ECHA, 2017). This guidance
provides information how to address risk assessment in case no data on
soil organisms at all would be available. According to this guidance
existing information on aquatic toxicity data (PNEC aqua) and adsorption
potential in soil shall be considered to assign substance to a “soil
hazard category” and to perform a screening assessment. Aquatic toxicity
data are available for all trophic levels and a PNEC freshwater is
derived to be 0.1 mg/L. The risk assessment performed showed no
indications of risks as all RCRs are below 1. Further there is no
indication for high adsorption of the substance in soil. All available
data for the main components of Tar acids, xylenol fraction (CAS
84989-06-0) demonstrate the log Kow to be below 3, i.e. xylenol-isomers:
2.09 to 2.42 (DEZA, 2010; EPA, 2010; Sangster, 1989); cresol-isomers:
1.94 to 1.98 (OECD SIDS, 2003; Sangster, 1989); ethyl-phenols: 2.09 to
2.58 (DEZA, 2010; Umeyama et al., 1971; Sangster, 1989), or
trimethyl-phenols: 2.67 to 2.73 (Sangster, 1989). Thus, Tar acids,
xylenol fraction (CAS 84989-06-0) exhibits low potential for adsorption
to soil (trigger log Kow < 5). Following the ITS also resuts in no need
for further testing with terrestrial organisms.
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