Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.414 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.141 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.033 mg/kg food
Assessment factor:
3 000

Additional information

PNEC water

There are no appropriate data available for PNECs calculations. Experimental short term toxicity studies are waived because of high insolubility of anthraquinone in water (In accordance with REACH Regulation (EC) No 1907/2006, Annex VII and Annex VIII). Seeing that the solubility is 74.6 micrograms per liter, substance meets the criteria for insolubility. The long-term aquatic toxicity study was performed according to testing proposal (study was performed according to method C.20 – Daphnia magna Reproduction Test, Council Regulation (EC) No. 440/2008, published in O.J.L 142, 2008).

There are five acute toxicity studies available (three for fish, one acute toxicity study to freshwater invertebrates and one for marine organisms) with reliable results and where selection of the test concentrations was based on the limit of water solubility of anthraquinone. Based on these data it was established that under the conditions maintained during the studies anthraquinone is not acutely toxic to fish, daphnids and eastern oysters at and below the material's limit of water solubility.

The same result was obtained in long-term reproduction test on Daphnia magna, where the anthraquinone do not display toxicity at and below the water solubility limit. The highest calculated reduction in reproductive output was 1.8 % and the exact values of EC50could not be calculated on the basis of data acquired (21 d–EC50>0.0539 mg.L-1 (average measured concentration)). The assumed value of EC50 is higher than solubility of the test substance in testing medium, no further testing is needed.

 

The considered substance is found to be non toxic in acute and chronic tests at its limit of water solubility. Estimation of PNECs value for aquatic environment is therefore impossible and use of sediment test should be considered as being more representative of the real environment.

  

PNEC STP

Since chemicals may cause adverse effects on microbial activity in STPs it is necessary to derive a PNECmicroorganisms. The PNECmicroorganismswill be used for the calculation of the PEC/PNEC ratio concerning microbial activity in STPs.

No reliable standard microbial inhibition test data are available. Results of toxicity study of anthraquinone (AQ) to microorganisms are above water solubility, thus the test result has to be considered as unreliable. Estimation of PNECs value for STP is therefore impossible. Although AQ is found to be nontoxic in acute and chronic tests at its limit of water solubility there is still a potential risk for water, and environmental exposure must therefore be minimised with appropriate risk management measures.

PNEC sediment

If result from whole-sediment test with benthic organisms is available the PNECsed has to be derived from this test using appropriate assessment factors.There is available one study on sub-chronic toxicity of sediment-sorbed to Chironomus tentans under flow-through conditions (Springborn Laboratories Inc., 1989). MATC - Maximum Acceptable Toxicant Concentration (concentration range encompassing the highest mean measured concentration that has no significant effect on the test organism performance and the lowest mean measured concentration that significantly affects the exposed organisms) ≥ 200 mg/kg sediment dw was determined in the study.

MATC is the geometric mean of the NOEC and the LOEC. If in the test report only the MATC is presented, the MATC can be divided by √2 to derive a NOEC.

The PNECsedimentis derived from the available NOEC141.42mg/kg sediment dw (MATC≥ 200 mg/kg sediment dw) obtained in sub-chronic test with Chironomus tentans by application of the assessment factor of 100 and is then expressed as:

PNECsed_fresh water= 1.414 mg/kg of dry sediment.

 The PNECmarine sediment is derived by application of the assessment factor of 1000 to the NOEC value from sub-chronic freshwater sediment tests and is then expressed as:

 PNECsed_marine water= 0.1414 mg/kg of dry sediment

 

 

PNEC soil

There are no appropriate data available for PNECs calculationsusing assessment factor (AF). Experimental toxicity studies are waived in accordance with REACH Regulation (EC) No 1907/2006, Annex IX and Annex X - studies do not need to be conducted if direct and indirect exposure to the soil compartment is unlikely.

When no toxicity data are available for soil organisms, the equilibrium partitioning method is applied to identify a potential risk to soil organisms. This method is regarded as a “screening approach” and aquatic toxicity (PNECwater) is used for calculation. PNECwatercould not be established due the lack of appropriate data and high insolubility in water.

PNEC oral

The PNECoral is ultimately derived from the toxicity data (food basis) applying an assessment factor.

If data on avian toxicity is available then the resulting PNECoralbirdis derived by applying an assessment factor (AF) to the available toxicity data.

The toxicity of AQ to bird Agelaius phoeniceus was reported as LD50= 100 - 300 mg/kg. Using AF 3,000 predefined for acute toxicity data,PNECoralbirdvaried from 0.033 to 0.1 mg/kg of food.

 

Conclusion on classification

According to Regulation 1272/2008 anthraquinone is not classified as hazardous to the aquatic environment.