Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.588 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
5.877 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.059 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
5.877 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.043 mg/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:
0.093 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
74 mg/kg food

Additional information

Conclusion on classification

Short-term aquatic toxicity data is available for all three trophic levels (daphnia, algae and fish). No effects up to the solubility limit were observed for fish. The daphnia EL50 was 0.9 mg/L (based on loading rate) and the algae ErC50 > 0.5877 mg/L (based on initial measured concentrations). Although, for the algae endpoint classification should be based on the ErC50 (EU CLP regulation No 1272/2008 and its adaption 286/2011), the EbC50 of 0.429 mg/L was also consider as supporting data for the acute classification of Adoxal given that the EC50 based on growth rate was greater than the solubility limit (maximum inhibition seen based on growth ate was 31%). Given that the three determined EC50 values (daphnia and 2 algae values) are between 0.1 and 1.0 mg/L, the substance is classified as Acute 1 with M factor of 1.

 

Chronic aquatic toxicity data is only available for one trophic level (algae). Therefore, the long-term hazard has been assessed based on both:

a) The chronic aquatic toxicity data for algae (ErC10 = 0.288 mg/L) and ready biodegradability of the substance, which results in a Category Chronic 3 classification, and

b) The acute aquatic toxicity data for daphnia (EL50 = 0.9 mg/L) and environmental fate data (readily biodegradable and log Kow of >6), which results in a Category Chronic 1 classification

c) The acute aquatic toxicity data for fish (no effects at solubility limit) and end environmental fate data (readily biodegradable and log Kow of >6), which results in a Category Chronic 4 classification

and classifying according to the most stringent outcome.

 

Thus it is concluded that the substance is classified Aquatic Chronic 1 (H411, M factor of 1) according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.

 

According to the old DSD regulation, Directive 67/548/EEC, the substance would be classified as R50/53 based on the EC50 values of >1 and < 10 mg/L and log Kow of > 3.