1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study planned (based on read-across)

Justification for type of information:

See the Justification for testing proposal in the Reinblau RLW dossier (CAS No 41611-76-1).

TESTING PROPOSAL
According to Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 3.0, June 2017), the registered substance should be classed as a soil hazard category 3 (log Kow > 5; no aquatic toxicity). Therefore, the Equilibrium Partitioning Method (EPM) has to be used as a screening assessment, for assessing the hazard to terrestrial organisms. However, as no aquatic toxicity were observed or estimated up to the highest attainable limit of solubility of the substance in acute and chronic exposure, it is not possible, neither required, to derive a PNEC aqua, and therefore not possible to derive a PNEC soil based on EPM. Nevertheless, in the context of an Integrated Testing Strategy for soil toxicity, a confirmatory long-term soil toxicity testing is requested. Normally, the choice of test (invertebrate / plant / micro-organisms) should be based on aquatic toxicity data to select the most sensitive organisms group. For the registered substance, due to lack of toxicity, the most sensitive organism group in aquatic toxicity cannot be determined, so the invertebrates earthworm species is proposed. Hence, a testing proposal is included in the dossier to conduct an earthworm reproduction test on Reinblau RLW, according to OECD Test Guideline 222.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
All substances included in the category approach are poorly water soluble with high adsorption coefficient (log Koc>6), high partition coefficient (logKow>8) and not readily biodegradable (see the category approach document for further details).
A testing proposal for an earthworm reproduction test is requested on the tested substance, Reinblau RLW (CAS n°41611-76-1). Only two substances of the category are Annex IX tonnage band substances, Reinblau RLW and Reinblau BLW (CAS n°32724-62-2), sharing the same physico-chemical properties. Reinblau RLW has been chosen for the present testing proposal and will be used as a read-across study for the Reinblau BLW.

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : no data available
- Available non-GLP studies : no data available
- Historical human/control data : not applicable
- (Q)SAR: : no data available
- In vitro methods: not applicable
- Weight of evidence: no data available
- Grouping and read-across: no data available
- Substance-tailored exposure driven testing : not applicable
- Approaches in addition to above : not applicable
- Other reasons: not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
Under Annex IX, Section 9.4., Column 2 of REACH, terrestrial toxicity studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely, and in the absence of toxicity data for soil organisms, the EPM may be applied to assess the hazard to soil organisms. However, it’s also mentioned that the choice of the appropriate tests depends on the outcome of the chemical safety assessment. In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider, or ECHA may require, long-term toxicity testing instead of short-term. Here, based on the chemical safety assessment, the substance is classified as a soil hazard category 3, and therefore a confirmatory long-term soil toxicity testing is requested. Annex IX, Section 9.4., Column 2 of REACH does not allow omitting the need to submit information on effects on terrestrial organisms under Column 1.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The proposed earthworm reproduction test (test method: OECD TG 222) is appropriate to cover the information requirement for short-term toxicity to invertebrates for substances that have a high potential to adsorb to soil or that are very persistent (ECHA Guidance R.7.11.2.1.), where long-term toxicity testing are preferred. The OECD Test Guideline 222 is applicable to all test chemicals irrespective of their water solubility. Therefore, no particular requirement are needed. In the context of the Integrated Testing Strategy for soil toxicity, a confirmatory long-term toxicity test is requested, e.g. a simplified study with a limit test to confirm the absence of risk for soil organisms. However, as the Equilibrium Partitioning Method (EPM) cannot be used as a screening assessment, for assessing the hazard, and then the risk, to terrestrial organisms, a full long-term toxicity test is proposed. The hazard and risk of the substance to terrestrial organisms will be based on this new data.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone

EC Number:

255-460-7

EC Name:

1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone

Cas Number:

41611-76-1

Molecular formula:

C32H30N2O2

IUPAC Name:

1,4-bis[(2-ethyl-6-methylphenyl)amino]-9,10-anthraquinone

Test material form:

solid

Details on test material:

Testing proposal: To be confirmed