Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
5.62 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
56.2 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.21 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:
0.417 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Short-term toxicity to fish:

Oncorhynchus mykiss; OECD TG 203; read-across.

96-h LL50 value of greater than 100 mg/L loading rate WAF

Short-term toxicity to aquatic invertebrates:

Daphnia magna; OECD TG 202. Read-across

48-h EC50 > 5.62 mg/L (measured) (100 mg/L nominal loading rate WAF)

Toxicity to aquatic algae:

Pseudokirchneriella subcapitata; OECD TG 201. Read-across

Results based on initial nominal loading rates (WAFs):

72 -h ErL50 > 100 mg/L; 72 -h NOErLR = 12.5 mg/L

Results based on initial measured concentrations:

72 -h ErC50 > 28.92 mg/L; 72 -h NOErC = 6.53 mg/L

The parent alcohol, Alcohols, C11-14 - iso-, C13-rich, is classified as Acute Aquatic 1 (H400), Acute Chronic 2 (H411). According to the Summation method specified Annex I: 4.1.3.5.5.3.1 of CLP, if a mixture contains > 25% of components classified as Acute 1, then the mixture is classified as Acute 1. The alcohol is present at 20 -40% w/w and therefore the Acute 1 classification is applied to all qualities. Similarly, according to 4.1.3.5.5.4.2, if a mixture is not classified as Chronic 1 and contains >25% of components classified as Chronic 2, then the mixture is classified as Chronic 2. The alcohol is present at 20 -40% w/w and therefore the Chronic 2 classification is applied to all qualities.