Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.197 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
4.44 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
19.49 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3.9 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
64.4 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The effect assessment has found a 72 h LC50of 1.77 โ€“ 1.95 mg Sb/L performed on the invertebrates Chlorohydra viridissma and Hydra oligactis (TAI, 1990) as the lowest valid value for acute toxicity. Although the hydra data is suitable for use in the risk assessment, the guidance on the classification and labelling of substances is clear that the hazard classification should be based on data for standard test species that are generated according to accepted test protocols (e.g. OECD testing protocols).  Such data take precedence over information that is generated with non-standard test species. The principle of classification is to indicate the relative toxicities of different substances and the use of data from standard test species would give a more consistent comparison against other substances which have classifications based on standard tests. 

For the purposes of classification, data for daphnids (DSD) or crustacea (CLP regulations) is preferred to fulfil the invertebrate endpoint. Therefore, the data for Hydra will not be used for the purposes of classification.

The lowest acute values for the different taxonomic groups are:ยท      

  • Fishfreshwater: 14.4 mg Sb/L (P.promelas, Brooke et al (1986))
  •  Fishmarine: 6.9 mg Sb/L (P.major, Takayanagi (2001))
  • Invertebrates: 12.1 mg Sb/L (D.magna, Kimball (1978))
  • Algae: >36.6 mg Sb/L (P.subcapitata, Heijerick & Vangheluwe (2004))

The marine fish P.major is not a standard test species, and classification is typically based on freshwater data when available.

The acute reference value for assessing the acute environmental classification of antimony (and antimony compounds) is therefore 12.1 mg Sb/L (= lowest acute value for the freshwater compartment). This value is higher than the Acute Cat.1 maximum threshold of 1 mg/L. It can thus be concluded that Sb and Sb compounds are not classified for the acute environmental endpoint.

Expressed as ATEG (molecular weight conversion), this value increases to 21.1 mg/L.

The lowest chronic values for the different taxonomic groups are:

 

  • Fishfreshwater: 1.13 mg Sb/L (P.promelas, Kimball (1978))
  • Invertebrates: 1.74 mg Sb/L (D.magna, Heijerick & Vangheluwe (2003))
  • Algae: 2.11 mg Sb/L (P.subcapitata, Heijerick & Vangheluwe (2004))

 

The chronic reference value for assessing the acute environmental classification of antimony (and antimony compounds) is therefore 1.13 mg Sb/L. (= lowest chronic value for the freshwater compartment). This value is higher than the Chronic Cat.1 maximum threshold of 1 mg/L. It can thus be concluded that Sb and Sb compounds are not classified for the chronic environmental endpoint.

Expressed as ATEG (molecular weight conversion), this value increases to 1.97 mg/L.