Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
88 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
8.8 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
366.7 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
36.7 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.2 µg/kg soil dw
Assessment factor:
10
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

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 anticipated.

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 suitable.

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.

Conclusion on classification

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.

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