[No public or meaningful name is available]

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.2 mg/L

Assessment factor:

50

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.93 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.02 mg/L

Assessment factor:

500

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

10 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.783 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.078 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:

0.039 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Aquatic toxicity potential of the test item was calculated using assessments of potential hazard of the test item to aquatic organisms (freshwater, marine water, sewage treatment plant (STP), freshwater sediment and marine sediment), air, terrestrial organisms (soil) and predators (via secondary poisoning).

In order to assess freshwater and marine water hazard, the following data were obtained from long-term studies on the test item:

- long-term toxicity to invertebrates: NOEC (21d, Daphnia magna) ≥ 10 mg/l (nominal), based on mortality and reproduction

- toxicity to aquatic algae: NOEC (72h, Pseudokirchneriella subcapitata) = 10 mg/l (nominal)

The same effect concentrations were reported for both trophic levels, therefore, it was not necessary to determine one most sensitive species, however, it should be noted that substances, which are dyes, are often not suitable for evaluating toxicity to algae as algal growth is inhibited by reduction of light source due to discolouration of test media. Therefore, available data for long-term toxicity to invertebrates is more representative of the actual toxicity of the substance, and Daphnia magna can be considered the most sensitive species. Therefore, the common NOEC value of 10 mg/l is used to calculate freshwater and marine water risks.

Additionally, in order to assess freshwater/marine water intermittent release hazard, the following data were obtained from short-term studies on the test item:

- short-term toxicity to fish: LD₅₀ (96h, Cyprinus carpio) = 180 - 320 mg/l (nominal)

- short-term toxicity to invertebrates: EC₅₀ (48h, Daphnia magna) > 100 mg/l (nominal; solubility limit)

- toxicity to aquatic algae: E_rC₅₀ (72h, Pseudokirchneriella subcapitata) = 93 mg/l (nominal)

The most sensitive species is considered to be algae and, as stated above, algal growth may be inhibited by reduction in light source rather than by toxicity of a substance. Therefore, the value of 93 mg/l should be considered as a worst-case scenario; likely, the true L(E)C₅₀ value may be higher. However, for the purposes of estimating the PNEC value, it is used.

The PNEC_freshwater value was found to be 0.2 mg/l; the PNEC_{marine water} value was found to be 0.02 mg/l; and the PNEC_{freshwater/marine water intermittent releases} was found to be 0.93.

In order to assess STP hazard, the following data was obtained from a respiration inhibition test:

- Toxicity to microorganisms: EC₅₀ (3 h) > 1000 mg/l

The PNEC_{microorganisms} value using the effect concentration of 1000 mg/l was found to be 10 mg/l.

Hazards to freshwater and marine water sediment were calculated using the equilibrium partitioning method due to the absence of experimental studies on sediment. The following equations were applied:

- PNEC_{freshwater sediement} = K_susp-water / RHO_susp × PNEC_freshwater × 1000 × 4.6

- PNEC_{marine water sediement} = K_susp-water / RHO_susp × PNEC_freshwater × 1000 × 4.6

Hazard to terrestrial organisms was also calculated using the equilibrium partitioning method due to the absence of experimental studies on soil organisms. The following equation was applied:

- PNEC_soil = K_soil-water / RHO_soil × PNEC_freshwater × 1000 × 1.13

In order to determine the K_susp-water/K_soil-water and RHO_susp/RHO_soil values, the EUSES software was utilised which calculated values based on physicochemical properties of the substance.

- PNEC_{sediment (freshwater)} was calculated to be 0.7823 mg/kg of sediment (dry weight);

- PNEC_{sediment (marine water)} was calculated to be 0.07823 mg/kg sediment (dry weight).

-PNEC_soil was calculated to be 0.03922 mg/kg soil (dry weight).

Biotic and abiotic hazards for air were not considered as the vapour pressure of the test item is negligible.

Hazard for predators(via secondary poisoning) was not considered as the test item is not considered to bioaccumulate.

Conclusion on classification

According to the CLP Regulation (EC 1272/2008), classification for acute aquatic toxicity as Category Acute 1 applies if:

96 hr LC50 (for fish) ≤ 1 mg/l and/or

48 hr EC 50 (for crustacea) ≤ 1 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

whereas, classification for long-term aquatic hazard of non-rapidly degradable substances for which there are adequate chronic toxicity data available applies if:

Category Chronic 1:

Chronic NOEC or ECx (for fish) ≤ 0.1 mg/l and/or

Chronic NOEC or ECx (for crustacea) ≤ 0.1 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants) ≤ 0.1 mg/l.

Category Chronic 2:

Chronic NOEC or ECx (for fish) > 0.1 to ≤ 1 mg/l and/or

Chronic NOEC or ECx (for crustacea) > 0.1 to ≤ 1 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants) > 0.1 to ≤ 1 mg/l.

Based on available studies on fish, crustacea and algae, Direct Blue 267 is not classified for acute aquatic toxicity.

Based on a NOEC determined in a long term study on crustacea along with a NOEC from a study on algae, Direct Blue 267 is not classified for chronic aquatic toxicity.