Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity data are available for all three trophic levels. The most sensitive species was Daphnia magna (48 -h EC50 = 34.1 mg/L; BASF SE, 2011; project no. 50E0117/10E112). The Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen is assessed to be acutely harmful for aquatic organisms.

Short -term toxicity to fish

In a GLP study according to OECD 203, the acute fish toxicity of the Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen to the zebrafish (Danio rerio) was studied. The test concentrations were analytically verified and remained within 20% of the nominal values. Based on nominal concentrations, the 96 -h LC50 is greater than 120 mg/L. The 96 -h NOEC was determined to be 120 mg/L (BASF SE, 2011; Project No. 17F117/10E120).

With high probability acutely not harmful to fish.

Long-term toxicity to fish

In Annex IX Section 9.1.6 column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or CLP-Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB.  The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.   In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 9, 10).  

Therefore, and for reasons of animal welfare, a long-term toxicity test on fish is not provided.

Short-term toxicity to aquatic invertebrates

In a GLP study according to OECD 202, the acute toxicity of the Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen to the waterflea (Daphnia magna) was studied. The test concentrations were analytically verified and remained within 20% of the nominal values. Based on nominal concentrations, the 48 -h EC50 is 34.1 mg/L. The 48 -h NOEC was determined to be 10 mg/L (BASF SE, 2011; Project No. 50E0117/10E112).

This result is supported by a screening test with Daphnia magna performed in the same laboratory under similar conditions, but without GLP conditions and analytical verification of the test substance concentrations. Based on nominal values, the EC50 was determined to be between 10 and 100 mg/L (BASF SE, 2010; Project No. 60E0117/10E119).

Acutely harmful to aquatic invertebrates.

Long-term toxicity to aquatic invertebrates

The long-term toxicity to aquatic invertebrates was investigated in a GLP study according to OECD 211 using Daphnia magna test species (BASF SE 2013; report no. 51E0117/10E132). The test concentrations were analytically determined. Reproduction was the most sensitive endpoint. The 21 -d NOEC was 3.2 mg/L, the 21 -d EC10 was 4.7 mg/L (nominal).

Based on the experimentally determined EC10 the substance is assessed to be chronically not harmful to aquatic invertebrates.

 

Toxicity to aquatic algae and cyanobacteria

In a GLP study according to OECD 201, the growth inhibition of the Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen to unicellular green algae (Desmodesmus subspicatus) was tested. The test concentrations were analytically verified. They remained within 20% of the nominal values, therefore the effect values are given based on nominal concentrations. Based on growth rate inhibition, the 72 -h ErC50 is greater than 220 mg/L. The 72 -h ErC10 was determined to be 75.6 mg/L (BASF SE, 2011; Project No. 60E0117/10E119).

With high probability acutely not harmful to aquatic algae.

Toxicity to microorganisms

The key study comes from a GLP guideline study following OECD TG 209 (2010). Domestic activated sludge was exposed to Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen (CAS no. 13897 -55 -7 and CAS 13897 -56 -8) for 3 h. The EC50 was 870 mg/L, the EC20 was 180 mg/L and the EC10 was 77 mg/L (BASF, 2012).

It can be concluded that the inhibition of the degradation activity of activated sludge is not anticipated when introduced in appropriately low concentrations.