Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.31 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.062 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.15 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
10 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
12.8 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
222.22 mg/kg food
Assessment factor:
90

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.

Conclusion on classification

The EU Risk Assessment Report has proposed a classification of the substance as R50/53 (N). According to Regulation 1272/2008, the classification is proposed as Acute Category 1 (H400 very toxic to aquatic life) and Chronic Category 1 (H410: Very toxic to aquatic life with long lasting effects) based on the EC50 for algae Skeletonema costatum of 32mg/L, the fact that the substance is not rapidly biodegradable and has a very high bioconcentration factor (BCF 18 100 in fish). The classification is supported by a 21-day daphnia study with a LOEC of 5.6mg/L. The algae study results may however, overestimate the toxicity of the commercial product due to the fact that the solubility was changed by using the eluate of a column extraction as test substance.

Toxicity to terrestrial organisms has been investigated in three trophic levels (earthworms, higher plants and soil microorganisms), the most sensitive trophic level has been identified as soil macro-organisms (earthworms). In general very little toxicity was observed for the three trophic levels, the most sensitive level giving a long-term NOEC value for reproduction of 128 mg/kg soil d.w. or 59 mg/kg dw when corrected for organic carbon content (earthworms; 56 days).

Higher animal toxicity via the food chain has been predicted from the results of the two generation reproductive toxicity study on rats. The study was a dietary study and gives a NOECmammal,food_chr value of 150 mg/kg food. .