Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

According to the available data the following PNEC values can be calculated:

PNEC freshwater = 1.85 mg/L

Rationale:An AF of 50 is applied to the lowest NOEC value (92.5 mg/L) obtained in two taxonomic groups. In this case this corresponds to a GLP compliant 21d daphnid reproduction test. Although there is no long-term test available in fish and the available long-term values are not obtained in fish, the available data on LC50 in medaka do not support that this is the most sensitive taxonomic group, it only reflects that no effect was seen at the highest concentration tested. The LC50 for fumaric acid supports the low toxicity of the group, but is not used in the calculation as its acidity at high concentrations in contrast with Na or K salts is likely to overestimate toxicity.

PNEC freshwater (intermittent release) = 10 mg/L

Rationale:An AF of 100 is applied to the lowest reliable LC50 value available for a C4 carboxyllic acid salt (>997 mg/L).

LC50 of malic and fumaric acid indicate low toxicity of the group as a whole but have not been used as they are likely to overestimate toxicity due to the higher acidity of the test solutions.

PNEC marine = 0.185 mg/L

Rationale: Given the limited availability of reliable marine data, the PNEC would have to be derived from the lowest of 2 freshwater NOEC values, as in the previous case. An additional safety factor of 10 is introduced to take account of greater diversity in marine taxons, thereby leadin to applying an AF of 500 upon the Daphnid NOEC of 92.5 mg/L. The suitability and usefulness of this PNEC is questionable given the very rapid degradability of the carboxyllic acid and the low likelihood of its entry into the marine environment after passing a sewage treatment plant.

PNEC STP = 10 mg/L

Rationale:An AF of 10 is applied to the lowest concentration which is known to have no effect on the innoculum in a rapid biodegradability test (92.5 mg/L). In this case this is 100 mg/L of analogue disodium tartrate in an OECD 301C 14d biodegradation test performed under GLP by the Japanese MoE (2001).

Conclusion on classification