Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.003 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0 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 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

Two long-term results are available from species representing two trophic levels (aquatic invertebrates and algae). Based on these data, and in line with REACH guidance R.10 (table R10 -4), in the REACH dossier that was submitted in 2010, an assessment factor of 50 was applied for derivation of the freshwater PNEC. According to the ECHA guidance R.7b, if based on acute aquatic toxicity there would be compelling evidence to suggest that fish is substantially (by at least a factor of 10) less sensitive than invertebrates or algae, no further fish test is considered necessary. As available acute aquatic toxicity data with fish indeed show that fish are at least a factor 10 less sensitive than both aquatic invertebrates and alga, the long-term toxicity to fish study is waived (see CSR section 7.1.1.2. for further details). Considering that further long-term testing with fish, if performed, would almost certainly provide a higher effect value than already available, the PPD REACH registration consortium members are of the opinion that by this approach the assessment factor for PNEC derivation should be chosen as if were chronic data from at least three species representing three throphic levels available. Therefore, an assessment factor of 10 is applied the lowest available chronic effect value, the 21 -d NOEC of 0.0051 mg/L as observed in the Daphnia reproduction test.

Conclusion on classification

Aquatic acute toxicity data are available for three trophic levels (fish, invertebrates and alga). The lowest acute toxicity value is the 72-hour EC50 of 0.27 mg/L from the study with freshwater green algae (P. subcapitata). Chronic toxicity data are available for aquatic invertebrates and for algae. The lowest chronic toxicity value is the 21 -d NOEC of 0.0051 mg/L from the reproduction study with Daphnia magna. Furthermore, the substance is characterised as not readily biodegradable and has a log Kow value <3.

Based on all these data, according to the CLP Regulation (EC) No 1272/2008, the substance needs to be classified as Aquatic Acute Category 1, H400 (Very toxic to aquatic life) with a M-factor of 1 and as Aquatic Chronic Caterory 1, H410 (Very toxic to aquatic life with long lasting effects) with a M-factor of 10. According to the Dangerous Substance Directive 67/548/EC, the available ecotoxicological and environmental fate data warrants classification as N; R50/53 (Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).