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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.049 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.49 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
15 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.35 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.024 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The substance is not classified for the environment, but an algal inhibition study did show that the algae was affected by the presence of the test item over a 72 -hour exposure period. Therefore, PNECs have been derived where appropriate.

PNEC water:

PNECs have been derived based on the results of freshwater and marine algal inhibition studies. However, the PNECs derived should be treated with caution as the results come from studies conducted using Water Accommodated Fractions (WAFs).

WAFs may be used in cases where the test item is a complex mixture and is poorly soluble in water and in permitted auxiliary solvents and surfactants. Exposures to the test organisms are expressed in terms of the original concentration of test item in water at the start of the mixing period (loading rate) irrespective of the actual concentration of test item in the WAF.

Therefore, as the substance comprises two constituents of varying solubility (one constituent being of low solubility), it was considered appropriate to conduct the aquatic toxicity testing using WAFS

Given that toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, results of the aquatic toxicity tested conducted, including the algal inhibition study, were based on nominal loading rates only.

PNECs derived from studies conducted using WAFs should be viewed with caution according to the ECHA Guidance; Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance.

PNEC oral:

A PNECoral for secondary poisoning is not required as the substance is not considered to be bioaccumulative (log Pow = 2.18) and will degrade rapidly (substance is readily biodegradable).

PNEC Soil:

PNECsoilwas estimated using equilibrium partitioning theory as described in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.10

A summary of the calculations are provided:

PNECsoil=(Ksoil-water/RHOsoil) x PNECwaterx 1000 x CONVsoil(Equation 7)

= (0.73/1700) x 0.049 x 1000 x 1.13

= 0.0239 mg/kg dwt

where:

PNECwater= 0.049 mg/L

RHOsoil= 1700 kg/m-3

Ksoil-water= 0.734 m3/m-3(See Equation 8)

CONVsoil= 1.13 kg/kg

Intermediate Values:

Ksoil-water= FairsoilxKair-water+ Fwatersoil+ Fsolidsoilx (Kpsoil/1000) x RHOsolid(Equation 8)

where:

Fairsoil= 0.2 m3/m-3

Kair-water= 3.78 x 10 -3(See Equation 9)

Fwatersoil= 0.2 m3/m-3

Fsolidsoil= 0.6 m3/m-3

Kpsoil= 0.356 L/kg (See Equation 10)

RHOsolid= 2,500

Kair-water= Henry / (R x Temp)(Equation 9)

where:

Henry = 82,680 Pa/m3/mol

R = 8.314

Temp: 285K

Kpsoil= Focsoilx Koc(Equation 10)

where:

Focsoil= 0.02 L/kg

Koc = 18 L/kg


 

Conclusion on classification

The substance is not classified for the environment based on the results of acute toxicity testing studies conducted on fish, invertebrates, and algae, with representative species from both freshwater and marine environments. The ready biodegradability and the substance physico-chemical properties, such as water solubility and partition coefficient, have also been taken into account.

 

The acute toxicity testing was conducted using Water Accomodated Fractions (WAF) of the test substance (see discussion sections of studies). Given that toxicity (if observed) cannot be attributed to a single component (or a mixture of components) but to the test item as a whole the results were based on nominal loading rates only, and are summarised below:

Acute toxicity to fish: The 96-Hour LL50 (lethal loading rate) based on nominal loading rates was greater than 100 mg/l loading rate WAF and correspondingly the No Observed Effect Loading rate was 100 mg/l loading rate WAF.

Acute toxicity to marine fish: The 96-Hour LL50(lethal loading rate) based on nominal loading rates was 530 mg/L.

Acute toxicity to Daphnia magna: The 48-Hour EL50 (effective loading rate) for the test item to Daphnia magna based on nominal loading rates was greater than 100 mg/l loading rate WAF. The No Observed Effect Loading rate was 100 mg/l loading rate WAF.

Acute toxicity to Acartia tonsa: The 48-Hour LL50(lethal loading rate) based on nominal loading rates was 117.4 mg/L.

Acute toxicity to freshwater algae:

EL50(growth rate):49mg/l

No Observed Effect Loading Rate: 25 mg/l

Acute toxicity to marine algae:

EL50(growth rate): 15 mg/l

No Observed Effect Loading Rate: 10 mg/l

The acute lethal loading level (expressed as the LL/EL50) is comparable to the LC/EC50 values determined for pure substances tested within their solubility range. They can therefore be used directly for classification.

 

Based on the results of the acute studies no lethal or sub-lethal effects were observed in fish or invertebrates magna at loading rates of 100 mg/l WAF.

 

For algae, the growth rate EL50 of 49 mg/l and 15 mg/L for freshwater and marine species respectively, is not sufficient for classification of the substance in Chronic Category 3 (for substances with a 72 hr ErC50 for algae of >10 to 100 mg/l), as the substance does not meet the other criteria required for Chronic Category 3 classification, which state the substance must also not be rapidly biodegradable and/or have an experimentally determined BCF500 (or log Pow≥ 4).

Therefore, the substance does not meet the criteria for classification for the environment.