Reaction products of diazotised 4,4-diaminodiphenylamine-2-sulfonic acid, subsequently coupled with 6-amino-4-hydroxynaphthalene-2-sulfonic acid, further diazotised and coupled with metaphenylendiamine, sodium salts

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.1 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

1 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.01 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.085 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.009 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:

0.055 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Studies on short-term toxicity in freshwater from each of the three trophic levels (on fish, aquatic invertebrate and aquatic plants) were available, which showed no toxicity of Direct Black 22 (DBk22) to aquatic organisms at the limit concentrations tested; also the test in microorganisms confirms that DBk22 is non-toxic.

 

DBk22 is unlikely to be present in the marine environment based on CSR and risk management measures, therefore the here derived PNEC marine aquatic, based on freshwater data, should be considered to be hypothetical.

 

Long-term toxicity was not tested because direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level. The risk management measures to avoid any release of the substance directly in the environment are discussed in detail within the exposure scenario; furthermore DBk22 has a low potential for bioaccumulation and aquatic toxicity is unlikely to occur as indicated by the short-term aquatic testing results.

Therefore, long-term toxicity testing is not necessary, because the chemical safety assessment according to Annex I does not indicate the need to investigate further the effects on aquatic organisms.

 

No data on terrestrial toxicity were available and no terrestrial testing was performed, because direct and indirect exposure of the soil compartment is unlikely. Based on CSR and risk management measures reported there is no soil exposure, thus no specific test is necessary.

 

Although toxicity is unlikely, PNEC values for aquatic toxicity and for terrestrial organisms have been anyway calculated for completeness sake.

On the contrary the PNEC for secondary poisoning was not calculated, because DBk22 is not expected to be bioaccumulable based on a Pow value of 0.0019.

Also the PNEC for air was not calculated because no hazard for the atmosphere compartment was identified, based on exposure considerations as well as the chemical and physical characteristics of DBk22..

Conclusion on classification

According to the CLP Regulation (EC n. 1272/2008), Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment (fish toxicity) when the following criteria are met:

A )Acute (short-term) aquatic hazard

Category Acute 1:

96 hr LC 50 (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

B) Long-term aquatic hazard

(iii) Substances for which adequate chronic toxicity data are not available

Category Chronic 1:

96 hr LC 50 (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

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 2:

96 hr LC 50 (for fish) > 1 to ≤10 mg/l and/or

48 hr EC 50 (for crustacea) > 1 to ≤10 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) > 1 to ≤10 mg/l (Note 2)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 3:

96 hr LC 50 (for fish) > 10 to ≤ 100 mg/l and/or

48 hr EC 50 (for crustacea) > 10 to ≤ 100 mg/l and/or

72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 4

Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log K ow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5.

Because of the low solubility of the substance in water both Daphnia and Algae tests have been conducted at the limit of solubility (saturated solution = 5 mg/l).

The value of EL50 in the test conducted on Daphnia Magna was greater than 5 mg/l. The same results was obtained in the study conducted with thePseudokirchneriella subcapitata (ErL50 > 5 mg/l).

In concusion, as no effects have been found at the limit of solubility, the test item isnot Classified for Aquatic toxicity.