Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
138 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
357 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
13.8 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.41 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:
8.75 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The acute toxicity of two similar substances to daphnia magna and algae was evaluated in rangefinding tests performed according to OECD 201 and OECD 202. For substance 1 ( A complex mixture which included alkyl naphthalenes, alkyl biphenyls, and alkyl benzene, low nonene alkylation) a NOEC could be calculated of 100 mg/L test substance. For substance 2 (A complex mixture which included alkyl naphthalenes, alkyl biphenyls, and alkyl benzenes + high nonene alkylation) a NOEC could be calculated of 10 mg/L test substance. The results obtained indicate that there is a slightly higher toxicity observed for test substance 2. As the results of these range finding tests are considered to be valid and because both test substances are very similar in their fate during the daphnia and algae tests, the conclusion as obtained from these tests is considered sufficient to select the more toxic substance as the worst-case representative in the hazard assessment of both substances. All concentrations have been converted on the basis of active ingredient concentrations.

Conclusion on classification

Classification according to GHS

Acute (short-term) aquatic hazard

Acute toxicity data for fish, crustacea and algae are > 10 mg/l. Therefore the substance needs no classification with Catagory Acute 1.

Long-term aquatic hazard

Acute toxicity data are available for fish, crustacea and algae and all E(L)C50 values are > 10 mg/l. Reliable chronic toxicity data are available for crustacea and algae and with chronic EC10 values > 1 mg/l. Further chronic fish testing has been waived to avoid unnecessary animal testing as the available data suggest that fish is equally sensitive to the substance as daphnia. Therefore additional information from a chronic fish test is not expected to alter the proposal not to classify the substance as hazardous to the aquatic environment. In addition the bioaccumulation potential of the substance is very low given the log Kow of -3.3. Based on the available information it can be concluded that chronic toxicity is > 1 mg/l and therefore the substance

does not meet the criteria for classification with Categories Chronic 1, 2 or 3.

Safety net classification

The safety net classification does not apply. The substance is inherently degradable and information on bioaccumulation is not available, but the low log Kow suggests a lack of bioaccumulation potential. In addition all chronic EC10 values are > 1 mg/l. Therefore the substance needs no classification as Chronic Category 4.

Conclusion classification according to GHS

Based on the results from the acute aquatic toxicity (values > 10 mg/l) and chronic aquatic toxicity (> 1 mg/l) and since the substance has a low bioaccumulation potential, but is not rapidly biodegradable, the substance needs no classification as hazardous to the environment according to the CLP Regulation 1272/2008.

Classification according to 67/548/EEC (DSD)

Acute aquatic toxicity is > 10 mg/l and the substance is not rapidly biodegradable. Chronic toxicity is > 1 mg/l and the substance has a low bioaccumulation potyential (log Kow of -3.3). Therefore the escape clause applies and the substance needs no classification as hazardous for the environment according to Directive 67/548/EEC.