Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acute toxicity to fish

The results of a static exposure test conducted according to DIN 38412 part 15, using Leuciscus idus as test species (BASF AG, 1987), indicate that the test substance is with high probability not acutely harmful to fish. Based on nominal test item concentrations the 96-h LC50 was determined to be in a range of 215 - 464 mg/L. Neutralization of the highest test concentration of 1000 mg/L completely abolished mortality. Therefore, the observed adverse effects may be due to pH.

The study was conducted without analytical monitoring. However, the stability of MIPA in the test medium is considered to be stable due to the high water solubility (miscible at any ratio; see IUCLID chapter 4.8), the low vapour pressure (63 Pa at 25 °C; see IUCLID chapter 4.6) and the low Henry's law constant (HLC: 4.95E-5 Pa*m3/mol; calculated; HENRYWIN v3.20, EPISuite v4.11) of the substance.

Additional studies using non-neutralized test solutions support these findings. Bridie et al. (1979), determined a 96 -h LC50 of goldfish exposed to non-neutralized samples as 210 mg/L whereas neutralization of the test solutions resulted in a 96-h LC50 of > 5000 mg/L. In a flow-through test Brooke and co-workers (1984) determined a 96 -h LC50 of 2520 mg/L for Pimephales promelas, when exposed to the test item using neutralized stock solutions.

In conclusion, substance is with high probability acutely not harmful to fish. 

 

Long-term toxicity to fish

The long-term toxicity to fish was estimated using the model ECOSAR v1.11 implemented in EPISuite v4.11 (chronic value = 327 mg/L). The substance was within the applicability of the estimation model; but as long-term prediction by the model has been developed based on a small data pool (training set: n < 5), the modeled results have a high uncertainty.

In addition, the ACR approach according to ECETOC (2003, Report no. 91) results in NOECs greater than 1 mg/L, based on the effect data of the acute toxicity study (BASF AG, 1987; report no. 10F0268/875180).

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.

 

Acute toxicity to invertebrates

The acute toxicity of MIPA (CAS 78-96-6) to aquatic invertebrates was determined in a static freshwater test conducted according to Directive 79/831/EEC, Annex V, Part C, using Daphnia magna as test species (BASF AG, 1992). The reported 48 -h EC50 of 108.8 mg/L indicates the test substance to be with high probability acutely not harmful to daphnids. The test substance solutions were not neutralized.

The study was conducted without analytical monitoring. However, the stability of MIPA in the test medium is considered to be stable due to the high water solubility (miscible at any ratio; see IUCLID chapter 4.8), the low vapour pressure (63 Pa at 25 °C; see IUCLID chapter 4.6) and the low Henry's law constant (HLC: 4.95E-5 Pa*m3/mol; calculated; HENRYWIN v3.20, EPISuite v4.11) of the substance. 

 

Long-term toxicity to aquatic invertebrates

The long-term toxicity to aquatic invertebrates was estimated using the model ECOSAR v1.11 implemented in EPISuite v4.11 (chronic value = 8.5 mg/L). The substance was within the applicability of the estimation model; but as long-term prediction by the model has been developed based on a small data pool (training set: n < 5), the modeled results have a high uncertainty.

In addition, the ACR approach according to ECETOC (2003, Report no. 91) results in NOECs greater than 1 mg/L, based on the effect data of the acute toxicity study to aquatic invertebrates (BASF AG, 1987; report no. 1/1131/2/87 -1131/87).

In Annex IX Section 9.1.5 column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on invertebrates. 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, a long-term toxicity test on aquatic invertebrates is not provided.

 

Toxicity to aquatic algae

The acute toxicity of MIPA (CAS 78-96-6) to aquatic algae and cyanobacteria was investigated in a test conducted according to DIN 38412, part 9, using Desmodesmus subspicatus as test organism (BASF AG, 1989). Based on growth rate, the 72-h ErC50 was determined to be 32.7 mg/L (72-h ErC10 = 15.1 mg/L) indicating the test substance to be acutely harmful to algae. The test substance solutions were not neutralized.

The study was conducted without analytical monitoring. However, the stability of MIPA in the test medium is considered to be stable due to the high water solubility (miscible at any ratio; see IUCLID chapter 4.8), the low vapour pressure (63 Pa at 25 °C; see IUCLID chapter 4.6) and the low Henry's law constant (HLC: 4.95E-5 Pa*m3/mol; calculated; HENRYWIN v3.20, EPISuite v4.11) of the substance.

In addition, Eide-Haugmo et al. (2012/2009) performed a guideline study according to ISO 10253 with the marine algae Skeletonema costatum. After 72 hours an ErC50 of 39.0 mg/L was determined.

 

Toxicity to microorganisms

In a short-term respiration test performed by BASF (1978) the 30-min EC20 for industrial activated sludge was >261 mg/L, corresponding to the highest tested concentration.

The study was conducted without analytical monitoring. However, the stability of MIPA in the test medium is considered to be stable due to the high water solubility (miscible at any ratio; see IUCLID chapter 4.8), the low vapour pressure (63 Pa at 25 °C; see IUCLID chapter 4.6) and the low Henry's law constant (HLC: 4.95E-5 Pa*m3/mol; calculated; HENRYWIN v3.20, EPISuite v4.11) of the substance.