Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Short-term toxicity to fish

The acute toxicity of the C.I. Pigment Red 3 to fish (Oryzias latipes) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1998). A static limit test with a saturated solution was conducted.Compared to the control, no signs of toxicity could be observed in the saturated solution (400mg/L). Therefore, the NOEC (48h) was determined to be higher than the concentration of a saturated solution of C.I Pigment Red 3 (>= 400 mg/l based on the nominal concentration).

Short-term toxicity to aquatic invertebrates

In an acute immobilisation screening test with Daphnia magna the effect of the saturated solution of both C.I. Pigment Red 3 and Pigment Orange 5 were determined according to OECD 202 and Directive 92/69/EC Method C.2. The limit tests were conducted under static conditions over 48 h.Compared to the control, no signs of toxicity could be observed in Daphnia magna with the saturated solution. Therefore, the NOEC (48h) was determined to be higher than the concentration of a saturated solution of both C.I. Pigment Red 3 and C.I. Pigment5.

Toxicity to aquatic algae

The toxicity of the test item (C.I. Pigment Red 3) to the unicellular freshwater green algal species Pseudokirchneriella subcapitata was determined according to the principles of OECD-Guideline 201. No inhibiting effects on specific growth rate and yield were found in the saturated solution of 6mg/L. The EC50-values for specific growth rate inhibition (ErC50) and inhibition of yield (EyC50) after 72 h were higher than the saturation level of the test item.

Toxicity to microorganisms

A Respiration Inhibition Test with activated sludge according to OECD Guideline No. 209 was carried out as a limit test for both C.I. Pigment Red 3 and C.I. Pigment5. The test was performed under static conditions with the nominal limit concentration of 1000 mg/L. The test item is not toxic at concentrations ≤ 1000 mg/L to activated sludge of a municipal sewage treatment plant.

Long-term toxicity to aquatic invertebrates

 

The test item C.I. Pigment Red 3 had no toxic effects on survival and reproduction of Daphnia magnaafter the exposure period of 21 days up to the highest test concentration of mean measured 35 μg/L (nominal 45 μg/L). This test concentration is clearly above the water solubility of the test item. The 21-day NOEC of the test item was determined to be at least 35 μg/L.

Thus, the test item C.I. Pigment Red 3 had no toxic effects on Daphnia magna at least up to its solubility limit in test water.

 

Long-term toxicity to soil macroorganisms

 

Mortality and reproduction was not affected in Earthworm Reproduction Test (OECD Guideline 222) with C.I. Pigment Red 3. NOEC was at least > 1000 mg/kg soil.

 

Toxicity to Terrestrial Plants

 

Seedling emergence and seedling growth in an OECD 208 study with C.I. Pigment Red 3 for 10 different plant species did not reveal any toxicity and NOEC was > 1000mg/kg soil.

Conclusion on classification

All acute and chronic tests showed no effects and the substance haslow potential forbioaccumulation. Therefore the information is conclusive but not sufficient for classification.