Registration Dossier

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):
0.005 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:
26 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
4.06 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.615 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
18 mg/kg soil dw
Assessment factor:
5
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Biodegradation: not readily biodegradable: 0% in 28 d (ISO 10708)

 

Bioaccumulation: BCF = 159 (OECD 305, read across) 

 

Aquatic short-term toxicity

96 h, LC50 (Brachydanio rerio): 0.46 mg/L (EU method C.1)

48 h, EL50 (Daphnia magna): 9.55 mg/L (OECD 202)

72 h, ErL50 (Desmodesmus subspicatus): > 100 mg/L (OECD 201) 

 

Aquatic long-term toxicity

91d, NOEC (Oncorhynchus mykiss): 0.006 mg/L (ASTM E 1241-05, read across)

21 d, NOEL (Daphnia magna): 2.8 mg/L (OECD 211)

72 h, NOELR (Desmodesmus subspicatus): ≥ 100 mg/L (OECD 201)

 

CLP

Based on the data above, Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched (CAS 244235-47-0) is not considered to be rapidly degradable. The bioaccumulation potential is low. Acute aquatic toxicity was observed below 1 mg/L. Valid chronic data are available with a NOELR (72 h) ≥ 100 mg/L for Desmodesmus subspicatus, a 21d-NOEL of 2.8 mg/L for Daphnia magna and a 91d-NOEC of < 0.1 mg/L (= 0.006 mg/L) for the read across substance Phenol,4 -nonyl-,branched (CAS 84852-15-3). Therefore, Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched (CAS 244235-47-0) needs to be classified and labelled as environmental hazard acute Cat.1 (M = 1) and Chronic Cat. 1 (M = 10) according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

 

DSD

The acute toxicity is below 1 mg/L and the substance is not readily biodegradable. Therefore,Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched (CAS 244235-47-0) needs to be classified and labelled as environmental hazardous (R50/53) according to Directive 67/548/EEC.