Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.004 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.112 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.013 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:
0.023 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Biodegradation in water: Readily biodegradable: 89 - 92.2% (ThCO, ThO2) in 28 days (OECD 301 B, OECD 301 F) (read across)

Log Kow: -0.63 (OECD 107)

Acute toxicity:

- to fish: LC50 (96 h) = 59.5 mg/L for Oryzias latipes (OECD 203); read across

- to invertebrates: EC50 (48 h) = 11.2 mg/L for Daphnia magna (OECD 202)

- to algae: ErC50 (72 h) = 91 mg/L for Pseudokirchneriella subcapitata (OECD 201); read across

Chronic toxicity:

- to fish: not available

- to invertebrates: NOEC (21 d) = 0.2 mg/L for Daphnia magna (OECD 211); read across

- to algae: NOErC (72 h) = 20 mg/L for Pseudokirchneriella subcapitata (OECD 201); readacross

Classification justification according to CLP

Based on the data above, sodium methylparaben is considered rapidly biodegradable. The acute aquatic toxicity E(L)C50 values are in the range from 10 – 100 mg/L forall trophic levels. Valid chronic toxicity data are available for Daphnia magna and the alga Pseudokirchneriella subcapitata with the lowest NOEC of 0.2 mg/L for Daphnia magna. Therefore, sodium methylparaben needs to be classified and labelled as environmental hazard Chronic Cat. 3 according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

M-factor for acute aquatic toxicity: no classification for acute toxicity

M-factor for chronic aquatic toxicity: No M-factor assigned

Classification justification according to DSD

Based on the data above, sodium methylparaben is considered to be rapidly degradable and to have low potential for accumulation. The acute aquatic toxicity E(L)C50 values are in the range from 10 – 100 mg/L for all trophic levels. Therefore, sodium methylparaben does not need to be classified according to the Directive 67/548/EEC.