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):
0.011 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:
20 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.151 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:
0.301 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

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 (OECD 302C)

 

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

 

Aquatic short-term toxicity

96 h, LC50 (Brachydanio rerio): 1.1 mg/L (EU method C.1, read across)

48 h, EL50 (Daphnia magna): 2.7 mg/L (EU method C.2, read across)

72 h, ErC50 (Desmodesmus subspicatus): 498.32 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): 0.189 mg/L (OECD 211, read across)

72 h, NOEC (Desmodesmus subspicatus): 101.2 mg/L (OECD 201)

 

CLP

Based on the data above, 5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde is not considered to be rapidly degradable. The bioaccumulation potential is low. Acute aquatic toxicity was observed to be above 1 mg/L. Valid chronic data are available with a NOELR (72 h) of 101.2 mg/L for Desmodesmus subspicatus, a 21d-NOEL of 0.189 mg/L for Daphnia magna and a 91d-NOEC of < 0.1 mg/L (= 0.006 mg/L) for Danio rerio tested with the read across substance Phenol,4 -nonyl-,branched (CAS 84852-15-3). Therefore, 5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde needs to be classified and labelled as environmental hazard Chronic Cat. 1 (M = 10) according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

 

DSD

The acute toxicity is between 1 and 10 mg/L and the substance is not readily biodegradable. Therefore, 5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde needs to be classified and labelled as environmental hazardous (R51/53) according to Directive 67/548/EEC.