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EC number: 252-552-9
CAS number: 35415-27-1
Hazard assessment for aquatic organisms
PNECaqua for both, freshwater and marine environment was derived on the
basis of two available freshwater long-term toxicity data, i.e. daphnia
and algae. Acute toxicity data was available for three trophic levels,
i.e. algae, daphnia and fish, where no acute toxic effects were
observed. In the long-term studies, daphnia magna was the more sensitive
species in comparison to algae (compare: 21d-NOEC (Daphnia magna,
reproduction) = 4.4 mg/L; 72h-NOEC (green algae, growth rate) = 27.0
mg/L). Therefore, PNECaqua was derived from daphnia magna toxicity data.
As no acute toxicity was observed for algae, daphnia and fish, no hazard
is anticipated for the aquiatic environment related to intermittent
releases. The same applies for STP microorganisms. No toxic effects were
observed up to the limit concentration of nominal 933 -1083 mg/L and
therefore no hazard is anticipated.
PNECsediment for both, freshwater and marine environment were derived on
the basis of the EPM method according to ECHA Guidance on Information
Requirements and CSA, R.10, because no other data was available.
PNECaqua freshwater or marine and log Koc of 5.67 were used.
The only adverse effects on aquatic organisms were observed in long-term
studies available for aquatic plants and daphnia, i.e. at concentrations
of 8 mg/L and 54 mg/L for daphnia and algae, respectively (in reference
to 21d-NOEC (Daphnia magna, reproduction) = 4.4 mg/L; 72h-NOEC (green
algae, growth rate) = 27.0 mg/L). In the acute toxicity tests covering
the three trophic levels, no toxicity was observed daphnia and fish. As
observed effect concentrations lie well above the water solubility of
the submission substance, no hazard is anticipated for the aquatic
environment. With regard to microorganisms, no inhibition was observed
on respiration up to nominal 933 -1083 mg/L test substance, and no
hazard is anticipated.
In addition, the enhanced ready biodegradability test shows
mineralisation of the submission substance over 60 days, leading to the
conclusion that the submission substance will not persist in the
environment and exposure of the aquatic environment to the submission
substance is limited.
With regard to sediment, no conclusion on the anticipated hazard can be
made, because no test data is available and approximation has been only
carried out according to the EPM method based on aquatic toxicity data.
According to REACH Annex IX, there is no data requirement for sediment
toxicity data, and in-depth evaluation of the sediment is not
Hazard assessment for terrestrial organisms
PNECsoil was derived by the equilibrium partitioning method according to
ECHA Guidance on Information Requirements and CSA, R.10. For the EPM
method, the derived PNECaquatic (freshwater) of 88 µg/L and log Koc of
5.67 were applied, plus assessement factor 10 for soil hazard category
3, i.e. log Koc > 5. Also the extrapolation method using assessment
factors was applied, because one long-term toxicity study is available.
The derived PNECsoil base on experimental data was higher and therefore
PNECsoil based on EPM was chosen:
PNECsoil (EPM): 2.2 µg/kg soil dw
PNECsoil (assessment factor): 930 µg/kg soil dw (available data:
17d-NOEC (Triticum aestivum, Lepidum sativum, Brassica alba; seedling
emergence, growth) >= 93 -108 mg/kg soil dw; assessment factor 100)
In order to conduct a refined hazard assessment on terrestrial organisms
in view of the high potential of the submission substance to adsorb to
soil, a testing proposal is included to investigate further effects on
terrestrial organisms. The included testing proposal is for the
earthworm reproduction according to OECD 222, which is considered
Hazard assessment for predators
No hazard assessment for secondary poisoning was carried out because
there is no potential to cause toxic effects if accumulated in higher
organisms: The substance is neither classified as STOT (category 1, 2),
toxic for reproduction (category 1A, 1B, 2) nor any other possible
effects are identified if accumulated in higher organism.
No hazard for predators such as secondary poisoning is expected.
Classification according to Regulation (EC) No 2008/1272 (CLP)
Acute hazard category
There are adequate short-term studies available covering three trophic
levels, i.e. algae, daphnia and fish. The submission substance does not
need to be classified for the environment according to Regulation No
(EC) 2008/1272, because the submission substance does not cause any
acute aquatic toxicity.
Chronic hazard category
There are two adequate long-term toxicity studies available, i.e. for
daphnia and algae. The more sensitive value was determined for daphnia
(21d-NOEC (Daphnia magna, reproduction) = 4.4 mg/L). Furthermore, no
acute toxicity was observed, and the submission substance is not rapidly
biodegradable. According to Regulation (EC) 2008/1272, the submission
substance does not need to be classified for the environment, because
the chronic effect concentrations are above 1 mg/L (see Regulation (EC)
No 2008/1272, Table 4.1.0(b)(i)).
In conclusion, the submission substance in not classified as hazardous
for the environment.
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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