Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
10
PNEC freshwater (intermittent releases):
0.026 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
PNEC marine water (intermittent releases):
0.003 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
3.1 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.128 mg/kg sediment dw
Assessment factor:
100

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.013 mg/kg sediment dw
Assessment factor:
1 000

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.054 mg/kg soil dw
Assessment factor:
1 000

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

Classification related key information

Readily biodegradable: 70.8 – 75.7% in 28 days (OECD 301B); read across

Acute aquatic toxicity freshwater:

-             Fish: LC50 (96 h): 2.6 mg a.i./L (measured, arithm. mean)

-            Aquatic invertebrates: LC50 (48 h): 2.7 mg a.i./L (nominal); read across

-            Algae: ErC50 (72 h): 3.57 mg a.i./L (measured, arithm. mean); read across

Chronic aquatic toxicity: 

-             Fish: NOEC (21 d): 0.036 mg a.i./L (measured, arithm. mean); read across

-            Aquatic invertebrates: NOEC (21 d): 0.006 mg a.i./L (measured, geom. mean); read across

-            Aquatic algae: NOErC (72 h): 0.468 mg a.i./L (measured, arithm. mean); read across

Conclusion on classification

Sodium 2-biphenylate (CAS 132-27-4) is readily biodegradable. The acute aquatic toxicity L(E)C50 values are > 1 mg a.i./L for fish, aquatic invertebrates and algae. The chronic effect concentration is < 1 mg/L (NOEC (21 d): 0.006 mg a.i./L). Based on the available dataset the substance is classified as Aquatic Chronic 1 according to the consolidated version of Regulation (EC) No. 1272/2008 (CLP) considering all further amendments. The substance Sodium 2-biphenylate (CAS 132-27-4) is listed on Annex VI (Index No.604-021-00-1)to CLP (in force from 1 March 2018). The harmonised classification and labelling is Acute Cat. 1 according to Annex VI to CLP. Therefore the self-classification is Acute Cat. 1 and Chronic Cat. 1 according to the consolidated version of Regulation (EC) No. 1272/2008 (CLP) considering all further amendments and Annex VI to CLP.

M-factor for chronic aquatic toxicity: 1