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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.9 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.9 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.09 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.073 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:
0.086 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10 mg/kg food
Assessment factor:
300

Additional information

All assessment and conversion factors used in the above PNEC calculations were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment; Chapter R.10: Characterisation of dose [concentration]-response for environment" along with appropriate equations and methodologies.

Due to the very low water solubility of the substance (<1 mg/L), aquatic ecotoxicity testing, and thus PNEC derivations, were based on Water Accommodated Fractions (WAFs) of nominal concentrations of the registration material. This was considered the most reliable and environmentally relevant method of testing.

It was deemed appropriate to derive PNECs using the most sensitive aquatic endpoint, therefore the acute Daphnia data was used despite the existence of a chronic study with Daphnia. This is because the EL50 value of 0.09 mg/L for the acute Daphnia study fell below the NOELR (mortality, growth and reproduction) of 0.14 mg/L for the chronic Daphnia study, logically it would be expected that this chronic NOELR should fall below the acute EL50. Both studies were conducted in accordance with relevant OECD guidelines, it is believed this discrepancy is likely due to difficulties in preparing WAFs at such low nominal loading rates for a UVCB material such as EC 424-820-7. It was therefore deemed appropriate to base PNEC derivation on the most sensitive/worst case endpoint.

The guidance on information requirements and chemical safety assessment Chapter R.10 p.19 states that: "An assessment factor of 100 applies also to the lowest of two long-term results (e.g. EC10 or NOECs) covering two trophic levels when such results have not been generated from that showing the lowest L(E)C50 of the short-term tests. This should, however, not apply in cases where the acutely most sensitive species has an L(E)C50 value lower than the lowest long term result (e.g. EC10 or NOECs) value. In such cases the PNEC might be derived by using an assessment factor of 100 to the lowest L(E)C50 of the short-term tests." The short-term Daphnia EC50 of 0.09 mg/l was the most sensitive endpoint and thus subject to the assessment factor of 100.

Conclusion on classification

Using the criteria set out in CLP Regulation (EC) No 1272/2008 Part 4: Environmental Hazards (as amended) the material will be classified as H400 Aquatic Acute Category 1 and H410 Aquatic Chronic Category 1. This classification is based on the worst case aquatic toxicity value, Acute Daphnia 48h EC50 = 0.09 mg/L. It was deemed appropriate to derive the classification using the most sensitive acute aquatic endpoint, despite the existence of two chronic studies at two separate trophic levels. This is because the EL50 value of 0.09 mg/L for the acute Daphnia study fell below the NOELR of 0.14 mg/L for the chronic Daphnia study. Both studies were conducted in accordance with relevant OECD guidelines, it is believed this discrepancy is likely due to the difficulties in preparing WAF at such low nominal loading rates of a UVCB material. Therefore, classifications categories for hazards to the aquatic environment were based on the most stringent/worse case aquatic toxicity values. M factors were derived similarly (using acute values, as per guidance).